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Clinical and demOgRaphic Features of Patients With Uncontrolled Severe Asthma in Russia (CORSAR)

NCT06472310
Recruiting
Conditions Severe Asthma
Phase Not Applicable
Enrollment 5000
Locations 40 sites
Compensation Not reported — ask the study team
Data Updated 2026-11-15
View Trial Details Official Listing I'm Interested
Study Details Design, interventions, and primary outcomes

About This Study

This study is an observational multicenter cross-sectional study. Planned study population consists of 5 000 adult patients with uncontrolled SA receiving treatment according to standard of care (except biologics). Planned number of study site is 50 outpatient centers with experience of uncontrolled SA treatment in about 50 regions of Russia (in order to describe characteristics of patients with uncontrolled SA in different regions in the most comprehensive way). This non-interventional study does not imply any intervention into a routine clinical practice, and does not provide for any diagnostic and therapeutic procedures other than those used in routine practice.

Design

Study type: Observational Observational model: Other Time perspective: Other

Primary Outcomes

  • To characterise the profile of routine therapy used for patients with uncontrolled SA not receiving biological therapy in proportion of patients receiving different classes of drugs will be calculated (June 2024 - June 2027)
  • To determine the pattern and trends of OCS prescription (June 2024 - June 2027)
  • To describe clinical and demographic characteristics of patients with uncontrolled SA not receiving biological therapy in Russian Federation mean age at the inclusion into the study will be collected (June 2024 - June 2027)
  • To describe demographic characteristics of patients with uncontrolled SA not receiving biological therapy in Russian Federation mean age at the primary asthma diagnosis will be collected (June 2024 - June 2027)
  • To describe demographic characteristics of patients with uncontrolled SA not receiving biological therapy in Russian Federation mean age at the diagnosis of SA will be collected (June 2024 - June 2027)
  • To describe demographic characteristics of patients with uncontrolled SA not receiving biological therapy in Russian Federation proportion of men and women will be calculated (June 2024 - June 2027)
  • To describe demographic characteristics of patients with uncontrolled SA not receiving biological therapy in Russian Federation data on mean body mass index (BMI) will be collected (June 2024 - June 2027)
  • To describe demographic characteristics of patients with uncontrolled SA not receiving biological therapy in Russian Federation proportion of patients with overweight will be calculated (June 2024 - June 2027)
Interested in this trial?
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Study Contact:
Study Information
Type: OBSERVATIONAL
Phase: Not Applicable
Status: Recruiting
Start Date: 2024-06-06
Completion: 2027-06-30
Eligibility
Age: 18 Years and older
Sex: ALL
Volunteers: false
Enrollment: 5000 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: AstraZeneca
Contact Information
Study Contact:
AstraZeneca Clinical Study Information Center
1-877-240-9479
information.center@astrazeneca.com
Interventions
N/A
Study Locations (40 sites)
Research Site, Astrakhan, Russia
Research Site, Barnaul, Russia
Research Site, Blagoveshchensk, Russia
Research Site, Bryansk, Russia
Research Site, Chelyabinsk, Russia
Research Site, Gatchina, Russia
Research Site, Irkutsk, Russia
Research Site, Izhevsk, Russia
Research Site, Kazan', Russia
Research Site, Kemerovo, Russia
Eligibility Criteria
Inclusion Criteria: 1. Age ≥ 18 years at the time of inclusion; 2. Signed and dated written informed consent in accordance with ICH GCP and local law prior to inclusion in the study; 3. Patients with diagnosis of uncontrolled SA (Asthma Control Questionnaire-5 (ACQ-5) score \> 1,5) established no less than 52 weeks prior to inclusion; Severe asthma is defined as asthma, that is controlled due to treatment with ICS in medium or high doses plus LABA and/or ALP, and/or LAMA, and/or systemic corticosteroids (sCS), and/or immunobiological therapy, while attempts to reduce the volume of therapy lead to a loss of symptom control, or asthma remains uncontrolled despite this treatment. Such therapy should be carried out at least 3 months before inclusion. Uncontrolled asthma is defined as ACQ-5\>1.5. 4. Patients with the availability of at least 52 weeks of follow-up data (prior to inclusion) in the medical records. Exclusion Criteria: 1. Patients receiving any biological therapy currently or within 52 weeks prior to inclusion; 2. Presence of chronic obstructive pulmonary disease (COPD) or idiopathic pulmonary fibrosis (ILF) currently or in the anamnesis; 3. The participation in any clinical study currently or within 52 weeks prior to inclusion; 4. An acute or chronic disease that, as deemed by Investigator, limits the ability of patients to participate in this study or could influence the interpretation of the results.

Theta-Burst Stimulation for Bipolar Depression

NCT06370988
Recruiting
Conditions Bipolar Depression, Bipolar Disorder, Tr...
Phase NA
Enrollment 124
Locations 2 sites
Compensation Not reported — ask the study team
Data Updated 2026-11-15
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Study Details Design, interventions, and primary outcomes

About This Study

The purpose of this trial is to determine if intermittent theta-burst stimulation (iTBS) can reduce the symptoms of depression in treatment-resistant bipolar disorder. To do this, some of the participants in this study will receive treatment with active iTBS stimulation, while others will receive sham iTBS stimulation. Participants will come for 30 days of either active iTBS or sham iTBS, with a 6-week follow-up period. Symptoms of depression (for determining treatment efficacy) and mania (for determining treatment safety) will be assessed using the 17-item Hamilton Rating Scale for Depression (HRSD-17) and the Young Mania Rating Scale (YMRS) every five treatments during the treatment course, and at 1 week and 6 week after treatment completion.

Design

Study type: Interventional Phases: Allocation: Randomized Intervention model: Parallel Primary purpose: Treatment Masking/blinding: Quadruple

Interventions / Regimen

  • Device: iTBS Stimulation — Fluid-Cooled B70 A/P Coil with either Magventure X100 or R30
  • Device: Sham iTBS Stimulation — Fluid-Cooled B70 A/P Coil with either Magventure X100 or R30

Primary Outcomes

  • Change on the 17-item Hamilton Rating Scale for Depression (HRSD-17) (From enrollment to 6 weeks post-treatment)
Interested in this trial?
Contact the study team directly or view the official listing
View on ClinicalTrials.gov I'm Interested
Study Contact:
Study Information
Type: INTERVENTIONAL
Phase: NA
Status: Recruiting
Start Date: 2024-05-15
Completion: 2029-05
Eligibility
Age: 18 Years – 65 Years
Sex: ALL
Volunteers: false
Enrollment: 124 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: Centre for Addiction and Mental Health
Collaborators: University Health Network, Toronto
Contact Information
Study Contact:
Hannah Taalman
416-535-8501
Hannah.Taalman@camh.ca
Mawahib Semeralul
416-535-8501
mawahib.semeralul@camh.ca
Eileen Lam
437-553-0367
Eileen.lam@uhn.ca
University Health Network
Interventions
  • Device: iTBS Stimulation — Fluid-Cooled B70 A/P Coil with either Magventure X100 or R30
  • Device: Sham iTBS Stimulation — Fluid-Cooled B70 A/P Coil with either Magventure X100 or R30
Study Locations (2 sites)
University Health Network, Toronto, Ontario M5T 2S8 Canada
Centre for Addiction and Mental Health, Toronto, Ontario M6J 1H4 Canada
Eligibility Criteria
Inclusion Criteria The participant must meet all of the inclusion criteria to eligible for this clinical trial: 1. Must be deemed to have capacity to provide informed consent; 2. Must be an outpatient 3. Have a DSM 5 diagnosis of bipolar disorder (type I or II), current episode depressed confirmed by Mini-International Neuropsychiatric Interview version 7.0.2 (MINI); 4. Age 18-65; 5. failure to achieve a clinical response to ≥1 adequate treatment trial for bipolar depression based on the Antidepressant Treatment History Form - Short Form (ATHF-SF) OR unable to tolerate at least 2 separate inadequate treatment trials for bipolar depression;43 6. moderately severe depression with a score ≥ 15 on the PHQ-9;44 7. not currently experiencing a mixed or manic episode (YMRS ≤10); 8. no increase or initiation of psychotropic medication with intention of treating depressive symptoms in the 4 weeks prior to screening. This excludes targeted treatment of insomnia with trazodone, melatonin, low-dose doxepin \[3-6mg\], low-dose benzodiazepines \[≤2mg lorazepam daily equivalent\], non-benzodiazepine benzodiazepine receptor agonists, or orexin antagonists; 9. able to adhere to the treatment schedule; 10. pass the TMS adult safety screening questionnaire.45 Exclusion Criteria An individual who meets any of the following criteria will be excluded from participation in this clinical trial: 1. have a history of MINI diagnosis of a substance use disorder (other than nicotine and/or caffeine) within the last 3 months; 2. have a concomitant major unstable medical illness; 3. have active suicidal intent (assessed during HRSD-17 Item 3 and SSRS as imminent intent to act on specific plan, confirmed by psychiatric staff); 4. are pregnant or intend to get pregnant during the study; 5. have a lifetime MINI diagnosis of schizophrenia or schizoaffective disorder; 6. have psychotic symptoms within the current episode; 7. have a MINI anxiety disorder, trauma-related disorder, obsessive compulsive disorder, or personality disorder assessed by a study investigator to be primary and/or causing greater impairment than BD-DE; 8. failure of an adequate acute course of ECT as defined by ATHF-SF during the current episode; 9. have received any rTMS before due to potential to compromise blinding of treatment allocation; 10. have any clinically significant neurological disorder (e.g., recent major cerebrovascular accident), or any history of seizure except those therapeutically induced by ECT or with clear precipitant (e.g., febrile seizure of childhood, alcohol withdrawal, etc.); 11. have any intracranial implant (e.g., aneurysm clips, shunts, stimulators,) or any other metal object within or near the head, excluding the mouth, that cannot be safely removed; 12. are participating in psychotherapy for less than 3 months. Patients will be permitted if they have been in stable treatment for at least 3 months prior to study entry, with no anticipated change in the frequency of therapeutic sessions, or focus of therapeutic sessions over the duration of the study; 13. are currently taking lorazepam \>2 mg daily (or equivalent) due to the potential to limit rTMS efficacy; 14. are currently taking any dose of an anticonvulsant due to the potential to limit rTMS efficacy. If anticonvulsants have been discontinued prior to screening, at least 5 half-lives have elapsed until screening to allow sufficient drug clearance; 15. have a non-correctable clinically significant sensory impairment (i.e., cannot hear well enough to cooperate with interview).

Open-Label Psilocybin Study in Transdiagnostic Population

NCT06442423
Recruiting
Conditions Transdiagnostic, Depression - Major Depr...
Phase PHASE1
Enrollment 50
Locations 1 sites
Compensation Not reported — ask the study team
Data Updated 2026-11-15
View Trial Details Official Listing I'm Interested
Study Details Design, interventions, and primary outcomes

About This Study

The primary objective of this study is to investigate the safety, feasibility, and tolerability of psilocybin treatment in individuals with functional impairment due to psychiatric symptoms. The secondary objective of this study is to determine whether individuals with functional impairments due to psychiatric symptoms will experience statistically significant symptom reduction and functional improvement from baseline symptom measurements (Visit 3) to 1-week (Visit 7), 4-weeks (Visit 8), and 6-weeks (Visit 9) post dosing. The investigators will recruit individuals with mood, anxiety, trauma, addictive, or related symptomatology, and who have functional impairment associated with these symptoms. A DSM-5 diagnosis is not required (nor is it an exclusion). The investigators will allow for comorbidity and only exclude based on psychological and physiological safety considerations. Critically, this approach will allow us to assess the tolerability of our interventions in individuals who would typically be excluded from efficacy studies due to various comorbid DSM-5 conditions. The investigators will employ an open-label study where participants will be given one dose of oral psilocybin 25mg. The investigators will also have follow-up visits at 1, 4, and 6 weeks and an optional long-term follow-up at 3, 6, and 12 months.

Design

Study type: Interventional Phases: Phase1 Allocation: Intervention model: Single Group Primary purpose: Treatment Masking/blinding: None

Interventions / Regimen

  • Drug: Psilocybin — Psilocybin will be administered in an opaque, size 2 gelatin capsule with approximately 180 ml of water to be orally ingested at Visit 5. The dose of psilocybin will be 25 mg.This is an open-label clinical trial with a single treatment arm. This is an open-label clinical trial with no blinding.

Primary Outcomes

  • Columbia-Suicide Severity Rating Scale (C-SSRS) (6 weeks)
  • Adverse Events Log (6 weeks)
Interested in this trial?
Contact the study team directly or view the official listing
View on ClinicalTrials.gov I'm Interested
Study Contact:
Study Information
Type: INTERVENTIONAL
Phase: PHASE1
Status: Recruiting
Start Date: 2024-10-17
Completion: 2027-12
Eligibility
Age: 18 Years and older
Sex: ALL
Volunteers: true
Enrollment: 50 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: Yale University
Collaborators: Usona Institute, State of Connecticut Department of Mental Health and Addiction Services, Brain & Behavior Research Foundation
Principal Investigators:
  • Benjamin Kelmendi, MD (PRINCIPAL_INVESTIGATOR) - Yale University
  • Gabrielle Agin-Liebes, PhD (PRINCIPAL_INVESTIGATOR) - Yale University
Contact Information
Study Contact:
Sarah Shnayder
(203) 737-3404
enact@yale.edu
Gabby Agin-Liebes, PhD
(203) 444-1795
enact@yale.edu
Connecticut Mental Health Center - Yale School of Medicine
Interventions
  • Drug: Psilocybin — Psilocybin will be administered in an opaque, size 2 gelatin capsule with approximately 180 ml of water to be orally ingested at Visit 5. The dose of psilocybin will be 25 mg.This is an open-label clinical trial with a single treatment arm. This is an open-label clinical trial with no blinding.
Study Locations (1 sites)
Connecticut Mental Health Center - Yale School of Medicine, New Haven, Connecticut 06519 United States
Eligibility Criteria
Inclusion Criteria: 1. At least one psychiatric symptom causing functional impairment over the past 30 days as established by a trained rater on the DIAMOND (at least "mild" impairment) and/or the WHODAS-2.0 12-item (a raw score of \>16) - assessment instruments indexing health and disability. 2. English fluency - able to understand the process of consent and the risk and benefits associated with the study, and able to provide written (signed and dated) informed consent form. 3. Agree to set up safe transportation after leaving the site following the dosing session. Acceptable arrangements include: arranging for a friend/family member to drive them home, pick them up and escort them home; if the participant is unable to arrange for a friend/family member to escort them home, the study staff will arrange private transportation and follow up with the participant to ensure that they arrived at their destination. 4. Must be able to identify a physician/treater that can be contacted to further assure that it is safe for the subject to participate and agree to sign a medical release for the investigators to communicate directly with this outside provider to confirm treatment and medical history via phone and/or email. 5. Ability to orally ingest pills for psilocybin dosing visit. 6. Must provide an adult contact (relative, spouse, close friend or other caregiver) who is willing and able to be reached by the PI and/or study personnel in the event of an emergency, and who can provide transportation for study visits if necessary and independently comment on any changes in the participant's mood or behavior after the administration of psilocybin. Be medically stable (no medical issues based on physical exam, labs and medical evaluation) as determined by screening for medical problems via a personal interview, a medical questionnaire, a physical examination, an ECG, and routine blood and urinalysis laboratory tests (see section 6.3.4 for labs). Must also demonstrate decisional capacity based on clinical assessment ensuring the participant can understand, appreciate, and reason through the study's purpose, procedures, and associated risks, as well as tolerate the potential effects of the study medication. 7. Be psychologically stable: Concurrent psychotherapy is allowed if the type and frequency of the therapy has been stable for at least one month prior to screening and is expected to remain stable during participation in the study (up to 4-weeks post-dosing). 8. If participant is of childbearing potential, must agree to use adequate birth control and not attempt to become pregnant during study up to 4 weeks post dosing session (see Section 6.3.3). If participant is of childbearing potential, must have a negative urine pregnancy test at study entry and prior to the dosing session. Participants who are FOCBP must not plan to become pregnant or donate eggs, starting at least 1 month before receiving the trial intervention and for at least 1 week after the final follow-up visit. A FOCBP is defined as a female who is considered fertile following menarche and until becoming postmenopausal, unless permanently sterile (see below). Females in the following categories are not considered FOCBP: * Premenarchal. * Premenopausal with 1 of the following: 1. Documented hysterectomy or bilateral salpingectomy/tubal occlusion/oophorectomy. 2. Postmenopausal. * A postmenopausal state is defined as no menses for 12 months without an alternative medical cause. * Females receiving hormone replacement therapy (HRT) and whose menopausal status is in doubt will be required to use 1 of the nonhormonal, highly effective contraception methods if they wish to continue their HRT during the trial. Exclusion Criteria: Psychiatric Exclusion Criteria: 1. Personal history of a primary psychotic disorder (e.g., schizophrenia, delusional disorder, schizoaffective disorder) or Bipolar I disorder, or at least one first-degree relative with a diagnosis of primary psychotic disorder (e.g., schizophrenia, delusional disorder, schizoaffective disorder) or Bipolar I disorder. 2. Active suicidal intent or suicidal or non-suicidal self-injurious behaviors, as defined by a "yes" response to question 4 on C-SSRS within the past 6 months at screening or prior to dosing (Active Suicidal Ideation with Some Intent to Act, with or without Specific Plan). 3. Use of a classic psychedelic (i.e., LSD, psilocybin, DMT, mescaline) within the 3 months prior to enrollment (not including microdosing). 4. Use of ketamine within the past month at Screening. 5. History of regular and frequent use of a classic psychedelic (more than 10 times per year) in a structured, intentional setting over the past 10 years. Structured use refers to participation in organized retreats, ceremonies, or church services. Microdosing is not included. 6. History of Other Hallucinogen Use Disorder. 7. History of intolerance to drugs known significantly to alter perception (i.e., psilocybin, LSD, salvinorium A, mescaline). 8. Patients taking 5-hydroxytryptophan or St. John's Wort 9. A positive breathalyzer test 10. A positive urine toxicology screening, which detects the standard panel of five drugs (marijuana, cocaine, opioids/opiates, amphetamines, and phencyclidine (PCP)), as well as benzodiazepines, 3,4-methylenedioxymethamphetamine (MDMA). If a participant tests positive for any of these substances, the PI may request a retest during the screening phase. The exceptions to the exclusion are prescribed opioid pain medication and benzodiazepines, or over-the-counter non-narcotic pain medication. If a participant is prescribed benzodiazepines, the participant will be asked to refrain from taking on the day of the psilocybin dosing session. Additionally, participants will not be excluded from the study based on the use of cannabis. However, they will be instructed to refrain from use of cannabis on the day before, day of, and day following the drug administration session. Participants whose primary clinical presenting issue is substance use-related will not be excluded based on a positive test at screening but will be expected to adhere to the dosing day drug test produces (outlined in section 6.3.6). 11. Changes to psychotropic medication and/or dosages within the past 3 months. 12. Current or recent (within 2 weeks of enrollment) prescription of MAOI, Lithium, and/or methadone use. 13. Has a psychiatric condition that precludes the establishment of therapeutic rapport as evidenced by long-term patterns of unstable relationships, a history of significant stress- related paranoia, or identity disturbances. 14. Use of any other investigational drugs within 30 days prior to Screening. 15. Allergy to gelatin. General Medical/Laboratory Exclusion Criteria: 1. Hypertension at screening is defined as: systolic blood pressure \> 140 mmHg or diastolic blood pressure \> 90 mmHg, on the lowest of three measurements. 2. History of cardiovascular disease, including but not limited to clinically significant coronary artery disease, cardiac hypertrophy, cardiac ischemia, congestive heart failure, myocardial infarction, angina pectoris, coronary artery bypass graft or artificial heart valve, stroke, transient ischemic attack, or any clinically significant arrhythmia. 3. Any clinically significant abnormal electrocardiogram (ECG) finding, such as findings suggestive of ischemia or infarct, complete bundle branch block, atrial fibrillation or other symptomatic arrhythmias, or predominantly non-sinus rhythm, at Screening. 4. Resting QT interval with Fridericia's correction (QTcF) ≥ 450 msec (male) or ≥ 470 msec a. (female) at Screening, or inability to determine QTcF interval. 5. Presence of risk factors for torsades de pointes, including: long QT syndrome, uncontrolled hypokalemia or hypomagnesemia, history of cardiac failure, history of clinically significant/symptomatic bradycardia, family history of idiopathic sudden death or congenital lo

The Effect of Postpartum Debriefing on the Psychological Outcomes

NCT06824480
Recruiting
Conditions Well-Being, Psychological
Phase NA
Enrollment 72
Locations 2 sites
Compensation Not reported — ask the study team
Data Updated 2026-11-15
View Trial Details Official Listing I'm Interested
Study Details Design, interventions, and primary outcomes

About This Study

This study was planned to determine the effect of re-signification of birth in the early postpartum period on postpartum fear of childbirth, postpartum depression and birth trauma.

Design

Study type: Interventional Phases: Allocation: Randomized Intervention model: Parallel Primary purpose: Prevention Masking/blinding: Single

Interventions / Regimen

  • Behavioral: debriefing group — Women who volunteered to participate in the study and met the participation criteria were informed about the study. The first session will be held face to face in the clinic for 40 minutes. Then, the second session will be held by phone within 4-6 weeks after birth, with a total of 2 meetings with each woman for approximately 40 minutes.
  • Behavioral: control group — he women in the control group will be asked how the birth went within 12-24 hours after birth by the researcher as part of their routine care, but no detailed analysis or interpretation will be made.

Primary Outcomes

  • Personal Information Form (the first 12-24 hours after birth)
  • Birth Process Evaluation Form (the first 12-24 hours after birth)
  • Wijma Birth Expectation/Experience Scale B version (W-DBÖ-B) at Birth: (the first 12-24 hours after birth)
  • Wijma Birth Expectation/Experience Scale B version (W-DBÖ-B) at Birth: (ANNEX-3) (first 6-8 weeks after birth)
  • City Birth Trauma Scale (CityBiTS) (first 6-8 weeks after birth)
  • Edinburgh Postpartum Depression Scale (EDPS) (first 6-8 weeks after birth)
Interested in this trial?
Contact the study team directly or view the official listing
View on ClinicalTrials.gov I'm Interested
Study Contact:
Study Information
Type: INTERVENTIONAL
Phase: NA
Status: Recruiting
Start Date: 2024-02-01
Completion: 2025-06-15
Eligibility
Age: 18 Years – 45 Years
Sex: FEMALE
Volunteers: true
Enrollment: 72 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: Mersin University
Contact Information
Study Contact:
gozde gokce ısbir professor dr. Gozde GOKCE ISBIR
+905057782319
gozdegokce@gmail.com
Mersin University Mersin University
+903243610001
Mersin University
Interventions
  • Behavioral: debriefing group — Women who volunteered to participate in the study and met the participation criteria were informed about the study. The first session will be held face to face in the clinic for 40 minutes. Then, the second session will be held by phone within 4-6 weeks after birth, with a total of 2 meetings with each woman for approximately 40 minutes.
  • Behavioral: control group — he women in the control group will be asked how the birth went within 12-24 hours after birth by the researcher as part of their routine care, but no detailed analysis or interpretation will be made.
Study Locations (2 sites)
Mersin university, Mersin, Turkey (Türkiye)
Mersin University, Mersin, Turkey (Türkiye)
Eligibility Criteria
Inclusion Criteria: Women who volunteer to participate in the study, Whose mother tongue is Turkish, Who are between the ages of 18-45, Who are at least primary school graduates, Who are 37-42 weeks pregnant, Who are nulliparous, Who have a healthy pregnancy, Who do not have a psychological condition or psychiatric disorder, Who are monitored and cared for in the first 24 hours after birth at the Tarsus State Hospital Maternity Department, Who approve of the reinterpretation of birth application to be carried out by the researcher will be included in the sample. Exclusion Criteria: Those who did not volunteer to participate in the study, Those who gave birth before the 37th week of pregnancy, Those who were multiparous, Those who had abnormal medical conditions during pregnancy (placental disorder, preeclampsia, premature birth threat, etc.), Those whose native language is not Turkish, Those who have visual, speech and hearing impairments, Those who had an emergency cesarean section, Those who stayed in the hospital for less than 12 hours after birth, Those who received a psychiatric diagnosis during the postpartum period (except those diagnosed with postpartum depression and post-traumatic stress disorder related to birth), Those who could not be reached by phone during the follow-up of the study, Women who developed complications in the first 24 hours after birth and required intensive care, Those whose babies required neonatal intensive care during the postpartum period, Those who experienced another life event that traumatized the woman during the postpartum period (harassment, rape, earthquake, accident, loss of a loved one) etc.) Those who want to withdraw from the study at any stage of the study will not be included in the sample.

Psilocybin Microdosing With Psychotherapy for Treatment-Resistant Depression

NCT07183748
Recruiting
Conditions Treatment Resistant Depression
Phase PHASE2
Enrollment 20
Locations 1 sites
Compensation Not reported — ask the study team
Data Updated 2026-11-15
View Trial Details Official Listing I'm Interested
Study Details Design, interventions, and primary outcomes

About This Study

Objective: To assess the safety and efficacy of a six-week microdosing regimen of psilocybin combined with short-term, experience-based psychotherapy in patients with treatment-resistant depression who have not responded to previous pharmacological or long-term psychological interventions. Hypothesis: Compared to baseline, the group that begins with psilocybin will exhibit a more rapid reduction in depressive symptoms after six weeks, compared to the group that begins with placebo and receives only psychotherapy. Following the crossover between conditions, the placebo-first group will also show an accelerated reduction in these measures after the subsequent six weeks. Alternative hypothesis: No difference will be observed between groups in the rate of symptom reduction. Objective: To examine biological markers that may mediate potential improvements in depressive symptoms among participants receiving psilocybin microdosing compared to placebo. Hypothesis: Compared to baseline, six weeks of active psilocybin dosing will result in decreased levels of cortisol and inflammatory markers, and increased levels of oxytocin and BDNF in saliva. Objective: To assess psychological factors that may mediate potential improvements in depressive symptoms among participants receiving psilocybin microdosing compared to placebo. Hypothesis: Compared to baseline, six weeks of active psilocybin dosing will lead to increased cognitive flexibility, greater self-compassion, and enhanced present-moment awareness. Objective: To explore a subpopulation of women experiencing premenstrual symptom exacerbation (PMS) and the potential for improvement in depressive symptoms in the days preceding menstruation, if any. Hypothesis: Among women with worsened premenstrual symptoms, psilocybin will reduce premenstrual symptoms, specifically depressive symptoms, compared to baseline.

Design

Study type: Interventional Phases: Phase2 Allocation: Randomized Intervention model: Crossover Primary purpose: Treatment Masking/blinding: Triple

Interventions / Regimen

  • Drug: Psilocybin (drug) — 0.4 grams
  • Other: Placebo — Placebo

Primary Outcomes

  • Beck Depression Inventory -II (BDI-II) change from baseline (Baseline, Weeks 2, 4, 6, 8, 10, 12, and 24)
  • Columbia Suicide Severity Rating Scale (C-SSRS) (Baseline, Weeks 2, 4, 6, 8, 10, 12, and 24)
  • Mindful Attention Awareness Scale (MAAS (Baseline, Weeks 2, 4, 6, 8, 10, 12, and 24)
  • Five Facet Mindfulness Questionnaire (FFMQ) (Baseline, Weeks 2, 4, 6, 8, 10, 12, and 24)
  • Self-Compassion Scale, Neff, 2003b (Baseline, Weeks 2, 4, 6, 8, 10, 12, and 24)
  • The Quality of Life Enjoyment & Satisfaction Questionnaire (Q-LESQ-SF) . (Baseline, Weeks 2, 4, 6, 8, 10, 12, and 24)
  • Premenstrual symptoms screening tool: PSST, Steiner (Baseline, Weeks 2, 4, 6, 8, 10, 12, and 24)
  • Cognitive Flexibility Scale (Baseline, Weeks 2, 4, 6, 8, 10, 12, and 24)
Interested in this trial?
Contact the study team directly or view the official listing
View on ClinicalTrials.gov I'm Interested
Study Contact:
Study Information
Type: INTERVENTIONAL
Phase: PHASE2
Status: Recruiting
Start Date: 2025-12-01
Completion: 2028-06-01
Eligibility
Age: 18 Years – 65 Years
Sex: ALL
Volunteers: false
Enrollment: 20 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: Beersheva Mental Health Center
Collaborators: MSICS PHARMA LTD
Contact Information
Study Contact:
Oded Arbel, MD
+972506576691
oded.arbel@pbsh.health.gov.il
Dr. Arbel
+972506576691
oded.arbel@pbsh.health.gov.il
Mental Health Center Beer Sheva
Interventions
  • Drug: Psilocybin (drug) — 0.4 grams
  • Other: Placebo — Placebo
Study Locations (1 sites)
Mental Health Center Beer Sheva, Beersheba, Israel
Eligibility Criteria
Inclusion Criteria: * Age range between 18-65 years. * Diagnosis of treatment-resistant major depression as defined by the DSM-IV criteria (309.81) (ASA 1994) and determined by the BDI (BDI-II, 1996). * Willingness to discontinue psychiatric medication starting two weeks prior to the beginning of the study and throughout its duration, as well as to cease the use of drugs and licensed cannabis, and to suspend psychotherapy for the duration of the study. Participants also commit not to initiate psychiatric medication or psychotherapy during the study without consulting the research team. All under supervision within a day treatment framework. * Abstinence from drugs and other psychiatric medications. * Negative pregnancy test for women, and use of contraception by both men and women during the study period. * Willingness to sign a confidentiality waiver allowing the research team to consult with the participant's treating physician. * Willingness to provide the contact information of a close and relevant person in case suicidal ideation arises. * Commitment to participate in all stages of the study, including follow-up assessments. * Willingness not to participate in another study during the current study period. Exclusion Criteria: * Investigators and their immediate family members are not permitted to participate in the study. Immediate family is defined as the investigator's spouse, parent, child, grandparent, or grandchild. * Pregnant women, breastfeeding women, or women of childbearing age who are not using medically approved contraceptive methods (e.g., condoms). Men who are sexually active and may cause pregnancy but are unwilling to use contraception. * Significant unstable physical illness (including cardiac, hepatic, renal, respiratory, endocrinological, neurological, or hematological conditions), based on the investigator's judgment. * Psychotic spectrum disorders. * Bipolar disorder. * Post-traumatic disorder involving dissociative symptoms. * Uncontrolled anxiety disorder. * Chronic perceptual disorder (HPPD). * Head injury or cognitive impairment (including intellectual disability or dementia). * Severe suicidal risk or aggressive behavior toward others, as assessed by the investigator and standardized depression/suicide assessment questionnaires. History of chronic benzodiazepine use (at least 4 mg lorazepam daily for over two years), or signs and symptoms of benzodiazepine use within two weeks prior to randomization. * Alcohol and/or substance abuse within the past 6 months, based on the clinical judgment of the investigator. * Any active addiction (substance use disorder). * Current or past epilepsy. * Individuals with focal or generalized encephalopathy (e.g., tumor, stroke, meningitis, encephalitis), or head trauma that may be epileptogenic.

Intersession Processes in Psychotherapeutic Treatments Using an Ecological Momentary Assessment Approach (ISA-Bell)

NCT05553197
Recruiting
Conditions Depression
Phase NA
Enrollment 84
Locations 1 sites
Compensation Not reported — ask the study team
Data Updated 2026-11-15
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Study Details Design, interventions, and primary outcomes

About This Study

The effects of a monitoring intervention as an add-on to face-to-face Cognitive Behavioral Therapy (CBT) for depression are assessed in this randomised trial. Monitoring consists of Ecological Momentary Assessment (EMA) of symptoms and inter-session processes via mobile phones. Twenty sessions of face-to-face CBT + EMA are compared to twenty sessions of face-to-face CBT (treatment as usual, TAU). 84 patients with mild to moderate depression will be randomised to CBT + EMA or to TAU.

Design

Study type: Interventional Phases: Allocation: Randomized Intervention model: Parallel Primary purpose: Treatment Masking/blinding: None

Interventions / Regimen

  • Behavioral: Cognitive Behavioural Therapy (CBT) — 20 sessions of face-to-face, individual CBT
  • Other: Ecological Momentary Assessment (EMA) — Two four-week blocks of twice daily ecological momentary assessment (EMA) of symptoms and inter-session processes

Primary Outcomes

  • Patient Health Questionnaire (PHQ-9) (4-month follow-up)
Interested in this trial?
Contact the study team directly or view the official listing
View on ClinicalTrials.gov I'm Interested
Study Contact:
Study Information
Type: INTERVENTIONAL
Phase: NA
Status: Recruiting
Start Date: 2022-11-01
Completion: 2026-05-31
Eligibility
Age: 18 Years and older
Sex: ALL
Volunteers: false
Enrollment: 84 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: Birgit Watzke
Collaborators: Universität Tübingen
Principal Investigators:
  • Birgit Watzke, PhD (PRINCIPAL_INVESTIGATOR) - University of Zurich
Contact Information
Study Contact:
Louisa Jagmetti, M.Sc.
+41 44 635 73 28
louisa.jagmetti@psychologie.uzh.ch
Fiona Fäh
+41 44 635 73 21
fiona.faeh@psychologie.uzh.ch
Louisa Jagmetti, M.Sc.
+41 44 635 73 28
louisa.jagmetti@psychologie.uzh.ch
Psychotherapeutisches Zentrum Universität Zürich
Interventions
  • Behavioral: Cognitive Behavioural Therapy (CBT) — 20 sessions of face-to-face, individual CBT
  • Other: Ecological Momentary Assessment (EMA) — Two four-week blocks of twice daily ecological momentary assessment (EMA) of symptoms and inter-session processes
Study Locations (1 sites)
Psychotherapeutisches Zentrum Universität Zürich, Zurich, Canton of Zurich 8032 Switzerland
Eligibility Criteria
Inclusion Criteria: * ICD-10 diagnosis of mild or moderate depression, first or recurrent episode (F32.0, F32.1, F33.0, F33.1) * PHQ-9 ≥ 5 * Possession of smartphone with internet access * Signed informed consent Exclusion Criteria: * Acute or past suicidality; self-reported * Acute addiction (F10 - F19) * Dysthymia (F34.1), postpartum depression, or severe depression (F32.3; F33.3) * PHQ-9 \> 20 * Depression not main mental health concern * Planned onset or planned change in antidepressant medication * History of psychotic symptoms, bipolar disorder, personality disorders, or organic brain disorders * Cognitive impairment or physical disability that would hinder psychotherapy or the use of a smartphone

RCT for Latina Mental Health Using Web-Based Apps

NCT06874790
Recruiting
Conditions Mental Health, Anxiety, Depression, Well...
Phase NA
Enrollment 700
Locations 1 sites
Compensation Not reported — ask the study team
Data Updated 2026-11-15
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Study Details Design, interventions, and primary outcomes

About This Study

This study compares a choice-driven, interactive, evidence-informed storytelling web-based app intervention with links to resources and treatment (Tx) recommendations (made by a character via her blog) and Tx locator, to a web-based app with links to publicly available informational internet videos, MH resources, and a treatment locator for at least moderately anxious/depressed untreated English and Spanish speaking Latinas to determine if a story-based, character-driven approach is more effective for catalyzing mental health treatment initiation.

Design

Study type: Interventional Phases: Allocation: Randomized Intervention model: Parallel Primary purpose: Health Services Research Masking/blinding: Triple

Interventions / Regimen

  • Behavioral: Catalina — Catalina transmedia web-based app intervention with 10 story-based videos (including bonus story extender videos) totaling 31 minutes plus the blog of the character, "Veronica," which has MH resource links including Veronica's recommendations of at least 3 local Latinx-serving clinics in LA and Orange County ZIP Codes that offer low-cost MH Tx.
  • Behavioral: Control webpage — Links to informational videos (totaling 31 minutes) on depression and anxiety, listing of the same 3 local Latinx-serving clinics in LA and Orange County ZIP codes that offer low-cost MH Tx, and links to nationally available websites that offer resources (including access to service locators).

Primary Outcomes

  • Number of Participants Initiating Mental Health Treatment (MH Tx) (9 months)
Interested in this trial?
Contact the study team directly or view the official listing
View on ClinicalTrials.gov I'm Interested
Study Contact:
Study Information
Type: INTERVENTIONAL
Phase: NA
Status: Recruiting
Start Date: 2025-07-09
Completion: 2028-11-30
Eligibility
Age: 18 Years and older
Sex: FEMALE
Volunteers: true
Enrollment: 700 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: University of California, Los Angeles
Collaborators: National Institute of Mental Health (NIMH)
Principal Investigators:
  • MarySue V. Heilemann, PhD,RN,FAAN (PRINCIPAL_INVESTIGATOR) - UCLA School of Nursing
Contact Information
Study Contact:
Study Coordinator
310-210-4273
mediahealthstudy@gmail.com
Interventions
  • Behavioral: Catalina — Catalina transmedia web-based app intervention with 10 story-based videos (including bonus story extender videos) totaling 31 minutes plus the blog of the character, "Veronica," which has MH resource links including Veronica's recommendations of at least 3 local Latinx-serving clinics in LA and Orange County ZIP Codes that offer low-cost MH Tx.
  • Behavioral: Control webpage — Links to informational videos (totaling 31 minutes) on depression and anxiety, listing of the same 3 local Latinx-serving clinics in LA and Orange County ZIP codes that offer low-cost MH Tx, and links to nationally available websites that offer resources (including access to service locators).
Study Locations (1 sites)
UCLA, Los Angeles, California 90095 United States
Eligibility Criteria
Inclusion Criteria: * Latina (women who are from or have family ties to Latin America) * Currently resides in LA or Orange County * Age 18 and older * Able to speak, read, and write in English or Spanish * Score 10 or higher on GAD-7 and/or PHQ-8 * Access to the internet via smartphone, tablet, or computer * Not currently receiving mental health therapy or pharmacotherapy * Has not accessed mental health services during the previous 6 months Exclusion Criteria: * Not Latina or Hispanic * Under age 18

Promoting Active Therapy: Path to Wellness

NCT06858189
Recruiting
Conditions Depression, Anxiety, Physical Activity, ...
Phase PHASE2
Enrollment 60
Locations 1 sites
Compensation Not reported — ask the study team
Data Updated 2026-11-15
View Trial Details Official Listing I'm Interested
Study Details Design, interventions, and primary outcomes

About This Study

This project will examine changes in depression and anxiety following a 10-week intervention promoting nature-based physical activity in mental health settings. We will recruit ten licensed therapists whose caseload includes adults with depression and anxiety. Following a training by our team, each participating therapist will recruit six clients, who will be randomly assigned to the intervention or control condition. Clients in the intervention condition will engage in walk-and-talk therapy outdoors during weekly sessions and discuss strategies for being active outdoors on their own. We will assess changes in depression, anxiety, and nature-based physical activity in both groups.

Design

Study type: Interventional Phases: Phase2 Allocation: Randomized Intervention model: Parallel Primary purpose: Treatment Masking/blinding: Single

Interventions / Regimen

  • Behavioral: Walk-and-talk therapy — During the 10-week intervention, clients and therapists will engage in walk-and-talk therapy outdoors in natural settings during weekly therapy sessions. In addition, therapists will work with clients to set realistic goals for increased nature-based physical activity outside of the therapy setting. Therapists will check in with clients weekly regarding their progress and assist with goal revision, barrier planning, and self-monitoring.

Primary Outcomes

  • Participation in walk-and-talk therapy (Weekly throughout the 10-week intervention)
  • Perceived therapist support for nature-based physical activity (End of intervention (after 10 weeks))
  • Acceptability (End of intervention (after 10 weeks))
Interested in this trial?
Contact the study team directly or view the official listing
View on ClinicalTrials.gov I'm Interested
Study Contact:
Study Information
Type: INTERVENTIONAL
Phase: PHASE2
Status: Recruiting
Start Date: 2025-02-28
Completion: 2026-05-31
Eligibility
Age: 18 Years – 65 Years
Sex: ALL
Volunteers: false
Enrollment: 60 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: Kansas State University
Collaborators: REI Cooperative Action Fund
Contact Information
Study Contact:
Emily L Mailey, PhD
847-224-1199
emailey@ksu.edu
Gina M Besenyi, PhD
785-532-6765
gbesenyi@ksu.edu
Interventions
  • Behavioral: Walk-and-talk therapy — During the 10-week intervention, clients and therapists will engage in walk-and-talk therapy outdoors in natural settings during weekly therapy sessions. In addition, therapists will work with clients to set realistic goals for increased nature-based physical activity outside of the therapy setting. Therapists will check in with clients weekly regarding their progress and assist with goal revision, barrier planning, and self-monitoring.
Study Locations (1 sites)
Kansas State University, Manhattan, Kansas 66506 United States
Eligibility Criteria
Inclusion Criteria: * Current client of a participating therapist who has completed study training * Diagnosed depressive or anxiety disorder * Able to safely engage in moderate physical activity * Willing to complete all study requirements Exclusion Criteria: * Planning to discontinue therapy in less than 6 months * Active suicidal ideation * Does not pass exercise risk screener

Transcranial Ultrasonic Stimulation in Treatment-resistant Depression : an Open-label Pilot Trial

NCT06085950
Recruiting
Conditions Treatment Resistant Depression
Phase NA
Enrollment 32
Locations 1 sites
Compensation Not reported — ask the study team
Data Updated 2026-11-15
View Trial Details Official Listing I'm Interested
Study Details Design, interventions, and primary outcomes

About This Study

The primary objective of this study is to optimize the protocol for the TUS administration in patients with TRD while gaining an initial impression of treatment efficacy.

Design

Study type: Interventional Phases: Allocation: Non Randomized Intervention model: Sequential Primary purpose: Treatment Masking/blinding: None

Interventions / Regimen

  • Device: Transcranial Ultrasonic Stimulation prototype — Transcranial Ultrasonic Stimulation prototype delivers personalized low-intensity ultrasound stimulation

Primary Outcomes

  • Percent change in the Montgomery-Åsberg Depression Scale (MADRS) score from baseline to primary endpoint (Pre-treatment and Day 5 from start of intervention)
Interested in this trial?
Contact the study team directly or view the official listing
View on ClinicalTrials.gov I'm Interested
Study Contact:
Study Information
Type: INTERVENTIONAL
Phase: NA
Status: Recruiting
Start Date: 2023-05-09
Completion: 2028-06
Eligibility
Age: 18 Years – 75 Years
Sex: ALL
Volunteers: false
Enrollment: 32 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: Centre Hospitalier St Anne
Contact Information
Study Contact:
Marion PLAZE
+33 1 45 65 87 20
m.plaze@ghu-paris.fr
David ATTALI
d.attali@ghu-paris.fr
Marion Plaze, MD, PHD
0145658720
m.plaze@ghu-paris.fr
GHU Sainte-Anne
Interventions
  • Device: Transcranial Ultrasonic Stimulation prototype — Transcranial Ultrasonic Stimulation prototype delivers personalized low-intensity ultrasound stimulation
Study Locations (1 sites)
GHU Sainte-Anne, Paris, 75014 France
Eligibility Criteria
Inclusion Criteria: * Age between 18 and 75 years, * Diagnosis of major depressive episode (MDE) as part of major depressive disorder as defined by DSM-5 criteria * Severe MDE (HDRS-17\> 20) * Drug resistance to at least two well-conducted antidepressant treatment lines * With stable antidepressant treatment for at least 4 weeks before inclusion * Benefiting from a social security scheme * Having given their consent to participate Exclusion Criteria: * Psychiatric history other than a mood disorder * Neurological history, including epilepsy and intracerebral calcifications * History of substance use disorder other than tobacco * Contraindication to brain MRI (pacemaker, neurostimulator, injury from metallic shine, …) * Compulsory psychiatric care * Protected adults, people under legal safeguard * Pregnant or breastfeeding woman * Women of childbearing age who do not have a negative pregnancy test and are not using contraception

Phase 3 Study of Adjunctive Treatment With Seltorexant in Adult and Elderly Participants With Major Depressive Disorder and Insomnia Symptoms

NCT06559306
Recruiting
Conditions Depressive Disorder, Major
Phase PHASE3
Enrollment 752
Locations 205 sites
Compensation Not reported — ask the study team
Data Updated 2026-11-15
View Trial Details Official Listing I'm Interested
Study Details Design, interventions, and primary outcomes

About This Study

The purpose of this study is to know how well seltorexant works, and also to evaluate safety and maintenance effect of seltorexant compared with placebo as an adjunctive therapy to an antidepressant in improving depressive symptoms in participants with major depressive disorder with insomnia symptoms (MDDIS) who have had an inadequate response to current antidepressant therapy with a selective serotonin reuptake inhibitor (SSRI) or serotonin-norepinephrine reuptake inhibitor (SNRI).

Design

Study type: Interventional Phases: Phase3 Allocation: Randomized Intervention model: Parallel Primary purpose: Treatment Masking/blinding: Double

Interventions / Regimen

  • Drug: Seltorexant — Seltorexant will be administered orally.
  • Drug: Placebo — Matching Placebo tablets will be administered orally.
  • Drug: Selective Serotonin Reuptake Inhibitor (SSRI)/Serotonin-Norepinephrine Reuptake Inhibitor (SNRI) — SSRI/SNRI will be administered orally.

Primary Outcomes

  • Part 1: Change from Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score at Day 43 (Baseline, Day 43)
  • Part 2: Time from Randomization to the First Relapse in Participants Who Achieve a Stable Response (Time from randomization to the first Relapse during the maintenance phase (up to 2 years and 10 months))
Interested in this trial?
Contact the study team directly or view the official listing
View on ClinicalTrials.gov I'm Interested
Study Contact:
Study Information
Type: INTERVENTIONAL
Phase: PHASE3
Status: Recruiting
Start Date: 2024-07-25
Completion: 2029-05-04
Eligibility
Age: 18 Years – 74 Years
Sex: ALL
Volunteers: false
Enrollment: 752 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: Janssen Research & Development, LLC
Principal Investigators:
  • Janssen Research & Development, LLC Clinical Trail (STUDY_DIRECTOR) - Janssen Research & Development, LLC
Contact Information
Study Contact:
Study Contact
844-434-4210
Participate-In-This-Study1@its.jnj.com
Interventions
  • Drug: Seltorexant — Seltorexant will be administered orally.
  • Drug: Placebo — Matching Placebo tablets will be administered orally.
  • Drug: Selective Serotonin Reuptake Inhibitor (SSRI)/Serotonin-Norepinephrine Reuptake Inhibitor (SNRI) — SSRI/SNRI will be administered orally.
Study Locations (205 sites)
University of Alabama at Birmingham, Birmingham, Alabama 35294 United States
Chandler Clinical Trials, Chandler, Arizona 85224 United States
University of Arizona, Tucson, Arizona 85724 United States
SanRo Clinical Research Group LLC WCG Clinical Network, Bryant, Arkansas 72022 United States
Preferred Research Partners, Little Rock, Arkansas 72211 United States
PAMOJA Clinical Institute LLC, Anaheim, California 92801 United States
Axiom Research, Colton, California 92324 United States
Elite Research Network 6, Encino, California 91316 United States
Behavioral Research Specialists LLC, Glendale, California 91206 United States
WR PRI Los Alamitos, Los Alamitos, California 90720 United States
Eligibility Criteria
Inclusion Criteria: Participants in part 1 and direct enrollers to part 2: * Meet DSM-5 MDD, without psychotic features based upon clinical assessment and confirmed by the structured clinical interview for DSM-5 Axis I disorders-clinical trials version (SCID-CT) diagnosed with first depressive episode prior to age 60 * Have had an inadequate response to at least 1 but no more than 2 antidepressants, administered at an adequate dose and duration in the current episode of depression. An inadequate response is defined as less than (\<) 50% reduction but with some improvement (that is, improvement greater than \[\>\] 0%) in depressive symptom severity with residual symptoms other than insomnia present, and overall good tolerability, as assessed by the MGH-ATRQ, and this must include the participant's current antidepressant treatment * Is receiving and tolerating well any one of the following SSRI or SNRI for depressive symptoms at screening, in any formulation and available in the participating country: citalopram, duloxetine, escitalopram, fluvoxamine, fluoxetine, milnacipran, levomilnacipran, paroxetine, sertraline, venlafaxine, desvenlafaxine, vilazodone, or vortioxetine at a stable dose (at therapeutic dose level) for at least 6 weeks * Having a major depressive episode of at least moderate severity, as assessed with 17-item Hamilton Depression Rating Scale, implemented through the Structured Interview Guide (SIGH-D) in a blinded manner at screening and must not demonstrate a clinically significant improvement from the beginning to end of screening. Participants entering after completing part 1: * Must have completed Part 1 DB treatment phase * Can consistently tolerate study drug (at the end of Part 1), and there is no additional safety risk for the participant if they proceed to Part 2 * Was able to consistently follow the study procedures in Part 1 as judged by the investigator. * Must be medically stable based on clinical laboratory tests Exclusion Criteria: * Has a recent (last 3 months) history of, or current signs and symptoms of, severe renal insufficiency clinically significant or unstable cardiovascular, respiratory, gastrointestinal, neurologic, hematologic, rheumatologic, immunologic or endocrine disorders and uncontrolled Type 1 or Type 2 diabetes mellitus * Has a history of narcolepsy and seizures * Has current signs/symptoms of hypothyroidism or hyperthyroidism * Participants taking thyroid supplementation for antidepressant purposes * Has Cushing's disease, Addison's disease, primary amenorrhea, or other evidence of significant medical disorders of the HPA axis

Alteration of Symbiosis Intestinal Microbiota on Patients With Anorexia Nervosa

NCT05632497
Recruiting
Conditions Anorexia Nervosa, Dysbiosis, Anxious Dep...
Phase Not Applicable
Enrollment 120
Locations 1 sites
Compensation Not reported — ask the study team
Data Updated 2026-11-15
View Trial Details Official Listing I'm Interested
Study Details Design, interventions, and primary outcomes

About This Study

The purpose of this study will be to study the association between the level of psychic symptomatic of anorexia nervosa (AN) (intensity of food restriction, symptoms of anxiety and depression) and alteration of host environment symbiosis and the mechanism (dysbiosis of intestinal microbiota, increase of intestinal permeability, immunity alteration and low-grade inflammation).

Design

Study type: Observational Observational model: Case Control Time perspective: Prospective

Interventions / Regimen

  • Biological: Stool and blood samples — Stool and blood samples

Primary Outcomes

  • Eating Disorder (at baseline)
  • Anxio-depressive symptomatologic assessements by HAD score (at baseline)
  • Anxio-depressive symptomatologic assessements by scale of Beck BDI 13 (at baseline)
  • Anxio-depressive symptomatologic assessements by LSAS Lieboweitz social anxiety scale (at baseline)
  • Anxio-depressive symptomatologic assessements by MOCI (at baseline)
  • Anxio-depressive symptomatologic assessements (at baseline)
  • Physical exercise (at baseline)
  • Biological parameter (at baseline)
Interested in this trial?
Contact the study team directly or view the official listing
View on ClinicalTrials.gov I'm Interested
Study Contact:
Study Information
Type: OBSERVATIONAL
Phase: Not Applicable
Status: Recruiting
Start Date: 2024-05-23
Completion: 2026-10
Eligibility
Age: 18 Years and older
Sex: ALL
Volunteers: true
Enrollment: 120 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: Assistance Publique - Hôpitaux de Paris
Collaborators: Fondation de France
Principal Investigators:
  • Mouna HANACHI GUIDOUM, MD (PRINCIPAL_INVESTIGATOR) - Service de Nutrition Clinique, Hôpital Paul Brousse - APHP
Contact Information
Study Contact:
Mouna HANACHI GUIDOUM, MD
+ 33 6 70 39 42 37
mouna.hanachi@aphp.fr
Joël DORE
+ 33 1 34 65 27 09
joel.dore@jouy.inrae.fr
Interventions
  • Biological: Stool and blood samples — Stool and blood samples
Study Locations (1 sites)
Service de Nutrition Clinique, Hôpital Paul Brousse (APHP), Villejuif, 94800 France
Eligibility Criteria
Inclusion Criteria: For patients: * Patients aged ≥18 years; * Anorexia according to DSM-5 and CIDI (Composite International Diagnostic Interview); * Body mass index (BMI) (P/T2) \< 15; * Hospitalization for nutrition rehabilitation; * Covered by a health insurance; * Informed consent form signed. For Healthy Volunteers: * Aged ≥18 years; * 18.5 \< BMI (P/T2) \< 25; * Covered by a health insurance; * Informed consent form signed. Exclusion Criteria: For patients: * Patients no-responding all criteria of DSM-5 or CIDI scores; * Taken of antibiotic treatment 2 months / or laxativ 3 weeks before hospitalization; * Somatic comorbidity should perturb intestinal microbiota (Crohn's disease, diabetes and all other chronic inflammatory diseases); * Patients under guardianship; * Patients covered by french AME scheme. For Healthy Volunteers: * Any disease should perturb intestinal microbiota; * Recent ponderal variation; * Taken of antibiotic treatment 2 months or laxativ 3 weeks before hospitalization; * Under guardianship; * Covered by french AME scheme.

Couples' Affect in Relationships Study

NCT06907654
Recruiting
Conditions Depression Disorders
Phase NA
Enrollment 2000
Locations 1 sites
Compensation Not reported — ask the study team
Data Updated 2026-11-15
View Trial Details Official Listing I'm Interested
Study Details Design, interventions, and primary outcomes

About This Study

The goal of this clinical trial is to find out whether learning about well-being impacts the thoughts and feelings of romantic couples. The main question it aims to answer is: * Does gaining knowledge about well-being positively impact individuals and their romantic relationships? Participants will complete online surveys about their thoughts and feelings.

Design

Study type: Interventional Phases: Allocation: Randomized Intervention model: Parallel Primary purpose: Treatment Masking/blinding: None

Interventions / Regimen

  • Device: well-being app — The HMP app is a meditation-based smartphone app designed to promote and protect psychological well-being through sustainable skills training. The program is grounded in constituents of psychological well-being identified in empirical literature. HMP provides core content, with instruction administered through a curriculum of guided practices. HMP has guided audio practices that address 4 constituents of well-being: awareness, connection, insight, and purpose.
  • Behavioral: List of well-being resources — Participants will be given a list of resources that promote well-being.

Primary Outcomes

  • Change in Primary Participant-Rated Couples Satisfaction Index (CSI-16) (Baseline, Week 4, 3-Month Follow-Up, 1-Year Follow-Up, 2-Year Follow-Up)
  • Change in Second-Person PHQ-9 Rating of Primary Participant (Baseline, Week 4, 3-Month Follow-Up, 1-Year Follow-Up, 2-Year Follow-Up)
Interested in this trial?
Contact the study team directly or view the official listing
View on ClinicalTrials.gov I'm Interested
Study Contact:
Study Information
Type: INTERVENTIONAL
Phase: NA
Status: Recruiting
Start Date: 2026-08-04
Completion: 2028-12
Eligibility
Age: 18 Years and older
Sex: ALL
Volunteers: true
Enrollment: 2000 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: University of Wisconsin, Madison
Principal Investigators:
  • Simon Goldberg, PhD (PRINCIPAL_INVESTIGATOR) - University of Wisconsin, Madison
Contact Information
Study Contact:
Lily Smith
cares@chm.wisc.edu
Lily Smith
cares@chm.wisc.edu
University of Wisconsin - Madison
Simon Goldberg, PhD
University of Wisconsin - Madison
Interventions
  • Device: well-being app — The HMP app is a meditation-based smartphone app designed to promote and protect psychological well-being through sustainable skills training. The program is grounded in constituents of psychological well-being identified in empirical literature. HMP provides core content, with instruction administered through a curriculum of guided practices. HMP has guided audio practices that address 4 constituents of well-being: awareness, connection, insight, and purpose.
  • Behavioral: List of well-being resources — Participants will be given a list of resources that promote well-being.
Study Locations (1 sites)
University of Wisconsin - Madison, Madison, Wisconsin 53705 United States
Eligibility Criteria
Inclusion Criteria: * Age ≥ 18 years * Be either married, living together, OR in a dating relationship for at least 12 months * Proficiency in English * US citizen or permanent resident * If non-monogamous, must be able to enroll in the study with a primary partner with whom they spend the majority of their time. * Use of a smartphone (primary participant only) * Phone able to receive SMS text messages * Depression symptoms (≥ 5 on PHQ-9; primary participant only) Exclusion Criteria: * Severe physical or sexual relationship aggression during the past 6 months (any item endorsement on 5-item severe IPV screener) * Endorsement of active suicidality * History of psychosis or mania * Prior use of the Healthy Minds Program app * Prior significant experience with meditation * Severe hearing impairment that would interfere with the use of an audio-based intervention (primary participant only) * Did not pass video attention check * Investigators may also track the time it takes for participants to complete surveys and use survey timing as a method to flag for suspicious bot activity * Participant presents false or misleading information or other indicators that the participant may be participating in the study in bad faith. At screening, each participant's address will be checked and they will be excluded if the address is 1) invalid or 2) a non-residential address. Participants will also be excluded if the same email is provided for both partners. Participants will be excluded if they fail the attention check item in the baseline survey. Participants will be excluded if they complete their screeners \<= 20 minutes of each other.