Type: OBSERVATIONAL
Phase: Not Applicable
Status: Recruiting
Start Date: 2025-06-01
Completion: 2026-12-31
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The project investigates long-term prognosis and predictors of treatment outcomes for difficult-to-treat depression in patients in secondary psychiatric care. The current patient cohort was collected in 2012-2021 in the study "Pharmacogenetics in patients with depression with specific focus on difficult-to-treat depression, suicide attempt and CYP2D6". The cohort consists of 415 patients, examined carefully regarding diagnostic assessment and earlier treatment. All participants were also genotyped for the drug metabolizing enzymes CYP2D6 and CYP2C19. Blood samples were stored in biobank for other analyses linked to prognostic markers. The patient cohort will now be followed up with a review of medical records and extraction of register data for a period of 5 years after their participation in the original study. The purpose of the study is to improve treatment and increase knowledge about long-term prognosis in difficult-to-treat depression. This is done by examining symptom profiles, monitoring clinical course and suicidality, and examining prognostic markers.
The goal of this clinical trial is to learn if extended admission to the Kangaroo Mother Care (KMC) ward helps to prevent postpartum depression in mothers of low birthweight infants in a low-resource setting whose newborns were admitted to the neonatal intensive care unit (NICU) more than standard of care KMC. The main questions it aims to answer are: * Does longer KMC decrease the incidence of postpartum depression in mothers of low birthweight infants in a low-resource setting? * Does longer KMC improve neurodevelopmental outcomes of low birthweight infants at 6, 12, and 18 months in a low-resource setting? * What are the barriers to practicing KMC in low birthweight infants following hospital discharge in a low-resource setting? * What is the prevalence of paternal depression in a low resource setting? * Is it cost effective to admit preterm mother-infant dyads to the KMC ward following NICU discharge? Researchers will compare (extended admission to the KMC ward) to (standard of care KMC) to see if extended KMC decreases PPD in mothers of preterm infants in low-resource settings. Participants (infants) will: * At time of discharge from the NICU, when clinically stable, spend either \< 2 days in the KMC ward with their mothers or spend longer in the KMC ward until discharge. * Return to clinic at routine follow-up visits (at 2 weeks and at 6-8 weeks) where mothers will be screened for postpartum depression and fathers will be screened for depression. * Return to clinic for neurodevelopmental screening at 6, 12, and 18 months where mothers will be screened for postpartum depression and perceived social support and fathers will be screened for depression.
Postpartum women frequently experience impairments in sexual function, pelvic floor dysfunction, fatigue, and depressive symptoms, all of which may adversely affect their quality of life during the postpartum period. Although pelvic floor muscle training is recommended as part of postpartum rehabilitation, evidence regarding comprehensive physiotherapist-led exercise programmes specifically targeting postpartum sexual health remains limited. Furthermore, no standardized telerehabilitation programme has yet been evaluated using a randomized controlled trial design. The aim of this randomized controlled trial is to evaluate the effectiveness of the POSH-Ex (Postpartum Sexual Health Exercise) programme, a standardized 12-week physiotherapist-led telerehabilitation intervention designed to improve female sexual function and overall postpartum health after childbirth. Secondary objectives are to evaluate its effects on pelvic floor muscle strength, physical activity, fatigue, depressive symptoms, health-related quality of life, and body composition. A total of 84 postpartum women will be randomly allocated in a 1:1 ratio to either the intervention group or the control group. Participants in the intervention group will complete supervised online exercise sessions twice weekly for 12 weeks, while participants in the control group will receive usual postpartum care. Outcome assessments will be performed at baseline and immediately after completion of the intervention. The primary outcome is female sexual function assessed using the Female Sexual Function Index (FSFI). Secondary outcomes include pelvic floor muscle strength, physical activity, fatigue, depressive symptoms, health-related quality of life, and body composition. The findings are expected to provide high-quality evidence regarding the effectiveness of a standardized telerehabilitation programme for postpartum rehabilitation and may contribute to the development of evidence-based postpartum rehabilitation programmes and future clinical practice guidelines.
The goal of this clinical trial is to learn if a personalized arts-based social prescribing program, Art Pharmacy, delivered through a mobile app (SocialRx App) can improve mental health and social connectedness in adolescents aged 15-18 with depression or anxiety enrolled in Medicaid managed care. The main question it aims to answer is: Compared to stable treatment, does participation in the Art Pharmacy program through the SocialRx App improve depression, anxiety, social connectedness, and loneliness? Researchers will compare participants receiving the Art Pharmacy program and digital companion to those receiving stable treatment (no change to existing care) to evaluate its effects on mental health and social connectedness. Participants will: Be randomly assigned to either the Art Pharmacy program delivered through the SocialRx App or a control group receiving stable treatment. Complete online surveys at baseline and follow-up time points (e.g., 3, 6, 9, and 12 months). If assigned to the intervention group, Art Pharmacy, participants will receive monthly arts and cultural activity recommendations, attend activities, and interact with a care navigator delivered through the SocialRx App.
In addition to the "core" symptoms of ASD (i.e., impaired communication, impaired reciprocal social interaction and restricted, repetitive and stereotyped patterns of behaviors or interests), it is estimated that up to 70% of autistic people present at least one comorbid psychiatric disorder, leading to a deterioration in quality of life, a greater demand for support and worse prognosis and outcome. Anxiety and depressive symptoms would seem to be more present in individuals with Level 1 ASD, requiring their prioritisation against core symptoms. To date, the first-line treatment for autistic patients with comorbid depressive and/or anxiety symptoms is still debated and it is not always clear whether they may or may not benefit from psychotherapeutic and conventional psychopharmacological approaches. As such, growing evidence strengthens the therapeutic potential of the endocannabinoid (eCB) system modulation and of eCB-like compounds. The aim of this study is to provide a response to an unmet clinical need in this framework of psychic vulnerability by initiating oral therapy with palmitoylethanolamide (PEA), a nutraceutical/food supplement with proven anti-inflammatory and neuroprotective properties. Indeed, many conditions of psychological distress are thought to be underpinned by systemic inflammatory and/or neuroinflammatory processes, on which PEA has shown remarkable efficacy, including through modulation of the immune response and the interaction between the endocannabinoid system and the gut-microbiota-brain axis. The trial we are proposing is a 12-week open-label phase 2 study involving the daily intake of PEA 600 mg, at a dosage of 1 tablet/day. This study will be conducted at the Unit of Psychiatry of Santa Maria della Misericordia Udine University Hospital. Through this study, we wish to evaluate: the ability of PEA to alleviate symptoms of psychic distress (i.e., anxiety and/or depression) in Level 1 autistic adults; the safety and tolerability of sustained intake of PEA in Level 1 autistic adults; and the biological basis of PEA functioning. The study involves taking PEA orally once daily (600 mg daily) at the same time as a meal during the initial 12-week phase. Upon completion of the initial phase, subjects will be offered to enter an extension phase of the trial of an additional 24 weeks to assess treatment stability, with the possibility of titration of PEA to 1200 mg daily based on observed clinical compensation. Each participant will be on PEA treatment for up to 36 weeks. During the course of the study, periodic clinical re-evaluations will be conducted at our Day-Hospital setting. The trial will unfold through one screening visit, one baseline visit, and two follow-up visits (FUP, 4 weeks and 12 weeks apart). The patient will be administered standardized interviews by a qualified investigating physician; clinical objective examination, collection of blood and urine samples for standard hematochemical investigations…
This randomized clinical trial aims to compare the effectiveness and safety of accelerated intermittent theta burst stimulation (iTBS) with standard iTBS in adults with major depressive disorder. Participants will be randomly assigned to receive either accelerated or standard iTBS targeting the left dorsolateral prefrontal cortex, in addition to pharmacotherapy. The accelerated iTBS group will receive 45 treatment sessions over approximately 15 treatment days, while the standard iTBS group will receive 20 treatment sessions over 4 weeks. The primary objective is to compare changes in depressive symptom severity between the two treatment groups from baseline to the end of treatment. Depressive symptoms will be assessed using the 17-item Hamilton Depression Rating Scale (HAM-D17). The study will also evaluate other clinical outcomes, cognitive function, quality of life, sleep quality, neurophysiological measures, and treatment safety.
The aim of this randomised controlled pilot study is to evaluate the feasibility of the Nurture and Play (NnP) offered to a Danish population of psychosocial vulnerable pregnant women and their partners. More specifically the objectives of the study are to: * Test the feasibility of the NnP including both parents * Evaluate the recruitment procedure, the adherence as well as the participant's and professional´s experience of the intervention * Evaluate the collaboration between the hospitals and the municipalities. The study consists of: 1. A randomized controlled pilot study (n=20 women/couples) carried out according to the Standard Protocol Items: Recommendations for Interventional Trials SPIRIT statement for clinical trials. The parents who agree to participate in the study will be randomly assigned in a 1:1 ratio to either the intervention or the control group. In addition to care-as-usual, the intervention group will be offered to participate in the NnP adapted to include partners. The intervention consists of 11 group sessions (4 perinatal and 7 postnatal sessions) and will be provided to the parents in the intervention group from around 26 weeks gestation until the baby is around seven months old. Each group session will be led by a midwife and a health nurse and will consist of four to five mothers/couples. 2. A qualitative descriptive interview study aiming to evaluate the participants' and professionals´ experience of the intervention. Data will be collected through: * Online Questionnaires. * Interviews. * Videotaped settings.
This Randomized Controlled Trial (RCT) aims to assess the effectiveness and acceptability of the Unified Protocol (UP) in an online group format for the treatment of emotional disorders in adults. Participants will be 90 adults (45 in the control group and 45 in the experimental group) with diagnosis of long COVID and comorbid emotional disorders. Participants will be recruited at Hospital Royo Villanova from Zaragoza, Spain. In this study it will be explored whether the changes obtained after the intervention in emotional disorders and cognitive complaints are maintained over 12 months. Additionally, levels of chronic stress will be longitudinally evaluated in the experimental group through accumulated cortisol levels in hair, before and after the application of the UP.
Objectives: To assess the feasibility, acceptability and appropriateness of a family-authored digital ICU diary intervention for bereaved family members in Hong Kong ICUs, and to explore family members' experiences of writing digital diaries during and following patient death. Hypothesis: The ICU digital diary intervention will prove feasible, acceptable and potentially efficacious in reducing bereaved family members' PTSD, anxiety and depression at 1 and 3 months post-patient death compared with baseline measurements. Design and Subjects: A two-arm, assessor-blind pilot randomised controlled trial with subsequent qualitative process evaluation. Forty family members of ICU patients receiving life-sustaining treatment will be recruited from three Hong Kong public hospitals and randomised 1:1 to intervention or control groups. Instruments: Feasibility of Intervention Measure (FIM), Acceptability of Intervention Measure (AIM), Intervention Appropriateness Measure (IAM), Impact of Event Scale-Revised (IES-R), Posttraumatic Stress Syndrome-14 (PTSS-14) and Hospital Anxiety and Depression Scale (HADS). Intervention: Family-authored digital ICU diary via WhatsApp, commencing when a patient's treatment is deemed life-sustaining, continuing through death and a one-month bereavement period. Main Outcome Measures: Primary: recruitment rate, retention rate, compliance, feasibility, acceptability and appropriateness. Secondary: symptoms of PTSD, anxiety and depression. Data Analysis: Descriptive statistics for feasibility outcomes; repeated measures ANOVA and linear mixed effects models for psychological outcomes; thematic analysis for qualitative data.
To examine the trajectories of anxiety and depression symptoms over the course of oncological disease, and to assess potential predictors-sociodemographic (age, sex, marital status, employment status), clinical (tumor location, stage, treatment type, general health), psychological (coping strategies, quality of life, cognitive difficulties, fear of recurrence), and physical activity-and their association with support needs and utilization of psychosocial services.
The goal of this study is to investigate how a common antidepressant citalopram (which increases the levels of the chemical messenger serotonin), affects how a key area of the brain involved in depression (the amygdala) responds to emotional information. Healthy participants will undergo medical and psychiatric health screening, after which they will be assigned to receive either a single dose of citalopram (20mg) or placebo, and undergo brain scanning (7T fMRI) whilst viewing emotional faces. Since the scan uses high field strength, the investigators will be able to see effects of citalopram on different subfields within the amygdala which will help to understand how citalopram might be working.
Depressive symptoms are common among patients admitted to the intensive care unit (ICU) and may adversely affect recovery, participation in care, treatment adherence, quality of life, and outcomes after critical illness. Conventional antidepressants have limited utility for rapidly treating depressive symptoms during an ICU admission because of their delayed onset of action and potential drug interactions in medically complex patients. Ketamine is an N-methyl-D-aspartate receptor antagonist with rapid antidepressant effects when administered intravenously at subanesthetic doses. However, evidence regarding its efficacy and safety for depressive symptoms developing during critical illness remains limited. The KID-ICU trial is a Phase II randomized, double-blind, placebo-controlled, multicenter trial evaluating subanesthetic intravenous ketamine for moderate-to-severe depressive symptoms in adult ICU patients. Eligible participants are adults who have been admitted to an ICU for 6 or more days and have a Patient Health Questionnaire-9 (PHQ-9) score of 10 or greater. Participants will be randomized in a 1:1 ratio to receive either intravenous ketamine at 0.5 mg/kg, with a maximum dose of 60 mg per infusion, administered over 60 minutes once daily for 2 consecutive days, or normal saline placebo with an identical volume, appearance, and infusion duration. The primary efficacy outcome is the change in PHQ-9 total score from baseline to Day 14 after the second scheduled infusion. Secondary outcomes include the longitudinal trajectory of PHQ-9 scores through Day 30, clinically meaningful PHQ-9 response at Day 14, anxiety and depressive symptoms assessed with the Hospital Anxiety and Depression Scale, Clinical Global Impression scores, prespecified safety events, time to ICU and hospital discharge alive, and 30-day all-cause mortality. A total of 50 participants will be enrolled across participating ICUs in Argentina. Psychiatric and clinical follow-up will be provided to all participants regardless of treatment assignment.
The goal of this observational cross-sectional study is to investigate whether the severity of facial dysfunction is associated with psychological distress in patients with unilateral facial palsy. The main questions it aims to answer are: * Is there a significant relationship between the degree of facial muscle dysfunction (as measured by Sunnybrook Facial Grading Scale and EMG parameters) and levels of anxiety and depression (as measured by HADS)? * Does reduced facial function correlate with lower self-esteem levels (as measured by the Arabic version of the Single-Item Self-Esteem Scale)? Researcher will assess and analyze the correlation between facial motor impairment and psychological outcomes to determine whether greater functional impairment is associated with increased psychological distress. Participants will: * Undergo clinical assessment using the Sunnybrook Facial Grading Scale to evaluate facial nerve function * Receive electrophysiological evaluation using surface electromyography (sEMG) to measure muscle activity * Complete standardized questionnaires including the Hospital Anxiety and Depression Scale (HADS) and the Arabic Single-Item Self-Esteem Scale (A-SISE)
This study investigates the development of intra-abdominal hypertension and compartment syndrome in patients undergoing elective pancreatic procedures. Main objective is to determine the proportion of patients after pancreatic operation who develop elevated intra-abdominal pressure and assess its association with postoperative complication rates. Another goal of the study is to compare open versus robotic pancreatic procedures regarding the occurrence of intra-abdominal hypertension and abdominal compartment syndrome.
Breast cancer is the most common cancer type in European women. Patients treated for early non-metastatic breast cancer comprise a growing group of survivors due to early diagnosis and improved treatment. Many of these survivors experience adverse effects such as decreased bone mineral density, derangement of metabolic markers (fat, glucose, insulin) and increased blood pressure. Increasing risk of bone fracture and cardiometabolic disease (eg. diabetes mellitus type 2). The purpose of this study is to identify mechanisms behind cardiometabolic changes that may be connected to the (neo-)adjuvant treatment. On top of this we hope to indentify potential biological markers that can help prevent development of metabolic disease. We will be recruiting 120 post-menopausal women age 50-70 with early breast cancer and 1-2 times a year for 5 years examine bone mineral density, body composition, glucose and fat metabolism and nerve damage. A questionnaire will be used to collect information on diet, physical activity and quality of life. Derudover anvendes spørgeskemaer til at indsamle information vedrørende. This new knowledge will help clinicians start adequate preventive measures to help patients avoid cardiometabolic disease secondary to cancer treatment.
Since early-onset preeclampsia (EOPE) is commonly associated with inadequate placentation, placental insufficiency, chronic fetal hypoxia, oxidative stress, and heightened inflammation, these pathological processes may adversely affect hippocampal neuronal development and maturation of axonal pathways such as the fornix. These mechanisms support our hypothesis that fetal fornix and hippocampus dimensions may be reduced in pregnancies complicated by EOPE, forming the scientific basis of our study. Previous research has suggested a potential link between preeclampsia (PE) and altered neurocognitive development. However, no studies to date have specifically evaluated the relationship between EOPE and fetal fornix or hippocampus dimensions. Therefore, the objective of our study is to assess fetal fornix and hippocampus measurements in pregnant women with early-onset preeclampsia compared with healthy controls.
Metabolic surgery is an emerging option to treat obesity-related metabolic diseases (e.g., type 2 diabetes) and prevent cardiovascular disease (CVD). Metabolic surgery can profoundly alter the gut microbiota; meanwhile, gut microbiota may affect surgical outcomes. Longitudinal studies that examined pre- to post-surgery changes in gut microbiota and its relation to cardiometabolic health after surgery are limited. Furthermore, few studies have included African Americans, a population with high rates of cardiometabolic diseases. The investigators aim to fill these research gaps by establishing a longitudinal, observational study of metabolic surgery patients and applying multi-omics to identify stool, blood, and/or tissue microbial features related to post-surgery cardiometabolic outcomes. In the current study, the investigators plan to enroll up to 300 patients who undergo metabolic surgery at Vanderbilt University Medical Center and follow them for up to 10 years after surgery. Fasting blood and stool samples will be collected at pre-surgery and 3-month, 1-year, 2-year, and 3-year post-surgery clinical visits. Tissue samples (e.g., biopsies of the liver and adipose and remnants of the stomach) will be collected during operation. Meanwhile, participants will complete a REDCap survey at baseline and 1-year, 2-year, and 3-year post-surgery. Participants' electronic medical records will be used to obtain additional information and facilitate long-term follow-up. The investigators will evaluate pre- to post-surgery changes in the fecal microbiome and fecal and blood levels of metabolites and proteins and the associations of microbiome, metabolites, and proteins with cardiometabolic improvements after surgery. This study will advance our understanding of the role of gut microbiota in metabolic surgery, which may translate into novel approaches to identify and treat obese patients for better cardiometabolic health.
The goal of this prospective observational study is to determine whether the trajectory of optic nerve sheath diameter (ONSD) after osmotherapy weaning can predict rebound intracranial hypertension in adult patients with traumatic brain injury requiring osmotherapy for elevated intracranial pressure. The main questions it aims to answer are: Does the trajectory of ONSD during osmotherapy weaning predict the development of rebound intracranial hypertension? What is the diagnostic accuracy of serial ONSD measurements for the early detection of rebound intracranial hypertension? Researchers will compare patients who develop rebound intracranial hypertension with those who do not to determine whether changes in ONSD trajectory differ significantly between the two groups. Participants will: Undergo serial bedside ocular ultrasound examinations for ONSD measurement at predefined time points after osmotherapy weaning. Receive standard clinical management for traumatic brain injury according to institutional protocols; no additional therapeutic intervention will be administered. Undergo routine neurological assessments, laboratory investigations, and neuroimaging as clinically indicated. Be followed for the occurrence of rebound intracranial hypertension and relevant clinical outcomes during their ICU stay
External ventricular drainage is frequently used in neurocritical care, particularly in patients admitted for non-traumatic subarachnoid hemorrhage who develop hydrocephalus and/or intracranial hypertension. While external ventricular drainage is often initially lifesaving, its prolonged maintenance is associated with complications, especially infections and prolonged hospital length of stay. There is currently no consensus on the optimal weaning strategy. Two approaches are used in routine practice: direct clamping (the external ventricular drain is closed as soon as weanability criteria are met) and gradual weaning (the external ventricular drain level is progressively raised before final clamping). No randomized controlled trial has yet demonstrated the superiority of one strategy over the other in patients with non-traumatic subarachnoid hemorrhage. The investigators hypothesize that a direct clamping strategy, combined with daily screening of standardized weanability criteria, will reduce the duration of external ventricular drain maintenance compared with the conventional gradual weaning strategy. SEVDVE-2 is a multicenter, randomized, controlled, parallel-group, single-blind superiority trial that will compare these two weaning strategies in 170 adult patients admitted to critical care for non-traumatic subarachnoid hemorrhage with a first external ventricular drain inserted within the previous 3 days. Patients will be randomized 1:1, stratified on the presence of an intraventricular hematoma. The primary outcome is the number of external ventricular drain-free days alive at Day 28.
The investigators design a prospective, observational cohort study to provide contemporary information on the prevalence, characteristics, risk stratification，cost-effective ,treatments and prognosis of Chinese hospitalised adult patients with intracerebral hemorrhage.