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About This Study

To enroll in this clinical trial, prospective participants must meet stringent criteria. The participants need to fall within the age range of 18 to 64 and exhibit chronic depression at therapy resistance stage 2. This stage signifies that the participants have undergone unsuccessful treatment with at least two different antidepressants, despite adequate dosage and duration. Moreover, the participants should have engaged in at least 12 sessions of psychotherapy without experiencing significant relief from depressive symptoms. Additionally, participants must demonstrate the cognitive capacity to provide informed consent. Upon expressing interest in the study and consenting to participate, individuals undergo a thorough screening process. This screening encompasses a comprehensive clinical interview to assess medical and psychiatric history, as well as various medical tests. These tests include physical examinations, blood draws (which may include pregnancy tests for female participants), and electrocardiograms (ECGs) to evaluate heart function. Following the screening, participants are randomly assigned to one of three different treatment groups (Ketamine +TAU; Ketamine+CBASP, Placebo+CBASP). The study protocol involves a combination of psychotherapeutic treatment and either ketamine infusions or placebo. Throughout the study period, participants are subject to regular data collection, including psychological assessments, blood samples, and magnetic resonance imaging (MRI) scans. Participants' responses to treatment, as well as any changes in symptoms or side effects, are closely monitored. After completing the study, participants are offered follow-up therapy as part of standard care. MRI scans are conducted to examine changes in brain activity associated with treatment response and depressive symptomatology, particularly focusing on alterations in neural circuitry and thought processes. Additionally, participants are encouraged to report any changes in medication regimen or other treatments received during the study period.

Design

Interventions / Regimen

• Drug: Ketamine — Two ketamine hydrochloride (Ketamin Inresa 2 ml) infusions (interval 2-3 days) per week for three weeks, 6 infusions in total. Ketamine hydrochloride (Ketamin Inresa 2 ml) is applied continuously over a time span of 40 minutes with a subanesthetic dosage of 0.5 mg per kg body weight.
• Drug: Placebo — Two times placebo (Isotone E NaCL 0.9 %) infusions (interval 2-3 days) per week for three weeks, 6 infusions in total. Placebo is applied continuously over a time span of 40 minutes.
• Behavioral: CBASP — In addition to standard ward psychotherapeutic program (group and single sessions) with cognitive behavioural, sociotherapeutic, occupational therapy and physiotherapeutic elements, patients in the CBASP conditions receive one CBASP group session (50 min) per week for 12 weeks. The single sessions (one 50 min and one 25 min per week) contents are CBASP-specific.
• Behavioral: TAU — Standard ward psychotherapeutic program (group and single sessions) with cognitive behavioural, sociotherapeutic, occupational therapy and physiotherapeutic elements.

Primary Outcomes

• Change of depressive symptoms assessed with Montgomery-Åsberg Depression Rating Scale (MADRS) between start and end of treatment in a group comparison (3 months after enrollment)

About This Study

Depression is a leading cause of disability worldwide with a 19% lifetime prevalence in the United States. Dysfunctional reward processing is one of the core features of depression. Common treatments of depression include psychological therapies (e.g., cognitive behavioral therapy), medication (e.g., bupropion, sertraline) and psychological therapies and medication combined, but they may not address the function of the reward circuit in depression. These treatments often o not improve depressive symptoms in patients with depression who are classified as having treatment-resistant depression, and they may be unlikely to respond to further medication trials. Transcranial magnetic stimulation (TMS) is a non-invasive brain stimulation that enables us to selectively excite or inhibit neural activity. Multiple TMS pulses given consecutively are known as repetitive TMS (rTMS), and the primary clinical location for applying rTMS is the left dorsolateral prefrontal cortex (DLPFC) for treatment of depressive symptoms. Many of these studies have shown that rTMS to the DLPFC may result in decreased depressive symptoms, but is only partially effective (response and remission rates of 41.2 and 35.3%, respectively). This evidence supports the importance of evaluating the efficacy of rTMS in other brain regions, such as the orbitofrontal cortex (OFC), in the treatment of depressive symptoms rather than in the DLPFC.

Design

Interventions / Regimen

• Device: Repetitive Transcranial Magnetic Stimulation — 1. 4 weeks of active rTMS (total of up to 20 sessions) 2. 5 sessions per day for 5 consecutive days (total of up to 25 sessions)

Primary Outcomes

• Functional connectivity of orbital frontal cortex (OFC) (20 days or 5 days)
• Clinical outcomes (6 months)

About This Study

The purpose of this study is to determine if treatment with a single dose of RE104 for Injection reduces depressive symptoms or depressive symptoms mixed with anxiety symptoms in participants with Adjustment Disorder due to cancer or other illnesses such as Amyotrophic Lateral Sclerosis (ALS), Multiple Sclerosis (MS), Parkinson's Disease (PD) or Idiopathic Pulmonary Fibrosis (IPF) as compared to active-placebo.

Design

Interventions / Regimen

• Drug: RE104 for Injection — Single, subcutaneous dose of RE104 for Injection

Primary Outcomes

• RE104 30 mg versus RE104 1.5 mg change from baseline in MADRS total score (Day 7)

About This Study

This is a two-arm randomized controlled trial to compare telephone-based depression self-management (UPLIFT) to telephone-based support groups (BOOST). A sample of 120 English- and Spanish-speaking people with epilepsy (PWE) with elevated depressive symptoms will be enrolled. Both interventions are 8-week programs delivered in one-hour weekly sessions to groups of about 6 participants. Changes in depressive symptoms, quality of life and seizures will be assessed over 12 months. The trial will also examine mediators and moderators of treatment effects.

Design

Interventions / Regimen

• Behavioral: UPLIFT (Using Practice and Learning to Increase Favorable Thoughts) — UPLIFT is an 8-week program that combines cognitive behavioral therapy (CBT) and mindfulness techniques and is delivered to small groups of participants by phone. Each weekly session is 1 hour long and is comprised of a check-in period, teaching on the week's topic, group discussion, a skill-building exercise, and a home practice assignment. CBT-related skills include thought monitoring, identifying cognitive distortions, problem identification, goal setting, and identifying supports. Relaxation exercises are also used for coping and to facilitate awareness of the body. Mindfulness activities include attention to breath, sights and sounds and other meditations. Audio guides are provided for home practice of mindfulness exercises.
• Behavioral: BOOST (Bringing Out Our Strength Together) — BOOST is a telephone-based support program delivered in 8 weekly group sessions. Each weekly session is 1 hour long and is comprised of a check-in period, introduction of the week's topic, and group discussion. Weekly BOOST session topics include: (1) personal experience of epilepsy; (2) personal experience of mood problems (depression, anxiety, stress); (3) seizure triggers; (4) concerns related to epilepsy treatment (e.g., medication adherence, side effects); (5) changes in seizures over time; (6) the impact of behavior (e.g., sleep, substance use) on seizures; (7) social relationships and epilepsy; and (8) review of the BOOST experience.

Primary Outcomes

• Presence of clinically significant depressive symptoms (Baseline Visit)
• Presence of clinically significant depressive symptoms (3 month visit)
• Presence of clinically significant depressive symptoms (6 month visit)
• Presence of clinically significant depressive symptoms (12 month visit)

About This Study

Premenstrual dysphoric disorder (PMDD) is a sex-specific depressive disorder where depressive symptom severity drastically changes in relation to menstrual cycle phase. It is characterized by late luteal phase symptoms of affective lability, irritability, depressed mood, and anxiety. A lot remains unclear and further studies are needed in order to improve the understanding of PMDD and to differentiate it from major depressive disorder (MDD). To date, and in contrast to MDD, the neural correlates of PMDD have been sparsely and poorly investigated. The aim of this study is therefore to investigate the neural correlates of PMDD as compared to MDD and to relate them to stress reactivity. Therefore, three groups of naturally cycling women will be investigated and compared, namely (1) women with MDD, (2) women with PMDD, and (3) healthy control women. Stress and HPA axis activity are assumed to play a crucial role in the development of many mental disorders, including MDD. How stress reactivity and HPA axis activity are connected to PMDD still needs to be investigated. Furthermore, the HPA axis can affect or suppress the activity of the hypothalamic-pituitary-gonadal (HPG) axis, which is involved mainly in the reproductive, but also the immune system, making it an important candidate for the investigation of sex-specific differences in stress reactivity. There are sex-specific differences in stress reactivity, but also in the prevalence of stress-related diseases. Women are twice as likely to suffer from depression than men and the first onset of MDD usually peaks during the reproductive years. As to why these differences exist, a recent theory suggests that ovarian hormone fluctuations function as modulators of women's susceptibility to stress and that altered reactivity to stressors during different cycle phases plays a role in the etiology of depressive disorders. This hypothesis extends the Social Signal Transduction Theory of Depression which first and foremost relates depression to inflammation. They postulate a critical role of cytokines for understanding the pathogenesis of depression. Therefore, ovarian hormone fluctuations, but also inflammation in regard to MDD and PMDD and stress reactivity will be investigated in this study.

Design

Primary Outcomes

• neural stress reactivity / activation of the CCN (cognitive control network) during stress-related tasks (during the MIST (20 minutes))
• stress-related cortisol reactivity (five cortisol measurements at MRI arrival, before the MIST, 50 minutes after the MIST, 70 minutes after the MIST, 120 minutes after the MIST)
• TNF-alpha in response to stress-related task (blood sample before and after the MIST (approx. 120 minutes))
• CRP in response to stress-related task (blood sample before and after the MIST (approx. 120 minutes))
• IL-6 in response to stress-related task (blood sample before and after the MIST (approx. 120 minutes))
• activity of parasympathetic nervous system (PNS) in response to stress-related task (change of RMSSD in relation to HRV during MIST (20 minutes))
• activity of parasympathetic nervous system (PNS) in response to stress-related task (change of pNN50 of HRV during MIST (20 minutes))
• activity of sympathetic nervous system (SNS) (change of skin conductance during MIST (20 minutes))

About This Study

The purpose of this trial is to compare the treatment efficacy (improvement in depressive symptoms) of accelerated TBS protocol (where participants receive multiple TBS treatments daily) to conventional TBS protocol (where participants receive a single TBS treatment daily) in late life depression. In addition, the study also aims to determine if specific patterns of stimulation are more or less effective. To do this, all participants will receive active treatments, but some of the participants in this study will receive accelerated TBS and some will receive once daily TBS.

Design

Interventions / Regimen

• Device: TBS — Repetitive transcranial magnetic stimulation (rTMS) is a form of non-invasive neurostimulation that uses focused magnetic field pulses to directly stimulate cortical neurons. Theta burst stimulation (TBS) is a briefer form of patterned rTMS that has been shown to be effective against major depressive disorder. Each treatment will consist of either 1) cTBS of right DLPFC followed by iTBS of left DLPFC; or 2) iTBS of left DLPFC.

Primary Outcomes

• Depression severity (6 weeks)

About This Study

This study will evaluate the efficacy of valbenazine on clinician- and patient-reported outcomes in participants with TD while receiving or after stopping a VMAT2 inhibitor.

Design

Interventions / Regimen

• Drug: Valbenazine — Valbenazine capsules for oral administration.

Primary Outcomes

• Change from Baseline in the Abnormal Involuntary Movement Scale (AIMS) Dyskinesia Total Score (AIMS 1-7) at Week 24 (Baseline, Week 24)

About This Study

This Phase II trial will examine engagement in telehealth for children undergoing psychotherapy. Specifically, the trial will examine patient engagement in Teleo, a virtual therapy platform specifically designed for psychotherapy with youth, as compared to standard video conferencing.

Design

Interventions / Regimen

• Other: Teleo — Therapist-led psychotherapy sessions implemented within the Teleo virtual therapy platform.
• Other: Standard Videoconferencing — Therapist-led psychotherapy sessions implemented in standard (non-Teleo) video platform.

Primary Outcomes

• Child Involvement Rating Scale (CIRS) (Week 1)

About This Study

The goal of this living-lab clinical trial is to test the effectiveness of digital health monitoring and feedback platform for community dwelling older adults. The main questions it aims to answer are: * Identify digital sensing variables that are predictive of mental and physical health declines and health emergencies of older adults * Develop digital health monitoring service to inform individualized daily health status of older adults users * Develop ICT network to share the daily health status and emergency signals with community based healthcare service providers and family caregivers if an older adult user approves of them to receive their health information. Participants will be asked to participate in a living lab using a wearable sensor, motion sensor, and smartphone applications for 6 weeks and also take part in pre-mid-post surveys to evaluate the usability, accuracy, and effectiveness of the digital healthcare service platform to improve health managements and connections with community and family caregivers. If there is a comparison group: Researchers will compare age and gender matched control group to see if health status of the living-lab group is better than the control group.

Design

Interventions / Regimen

• Behavioral: Living-lab digital intervention group — Older adults will receive individualized daily health feedback via the mobile applications, which will be shared with caregivers. They will also receive support for health emergency by the platform sending automatic emergency push alarm to community and family caregivers.

Primary Outcomes

• Patient Health Questionnaire-9 (PHQ-9) (Daily assessments across 6 weeks)
• Sleep fragmentation index (Daily assessments across 6 weeks)
• Daily steps (Daily assessments across 6 weeks)
• Intensity of physical activity (Daily assessments across 6 weeks)
• Heart rate variability (Daily assessments across 6 weeks)

About This Study

This is a parallel, two-arm interventional study comparing the Mental Health CPR behavioral intervention to standard community health education. The goal of this clinical trial is to learn if Mental Health CPR program, a culturally and linguistically adapted behavioral intervention, helps improve emotional well-being and access to mental health services among Hispanic/Latino cancer survivors in Puerto Rico. The main questions it aims to answer are: * Does Mental Health CPR help more people complete psychological distress screening? * Does it help more participants connect with psycho-oncology services? Researchers will compare the Mental Health CPR program to standard community health education to determine whether it improves emotional well-being, enhances communication between patients and caregivers, reduces negative attitudes toward mental health care, and lowers emotional distress levels. Participants will: * Attend community sessions led by trained Community Mental Health Workers (CMHWs) * Receive printed materials and educational resources * Take part in brief follow-ups over about 36 weeks

Design

Interventions / Regimen

• Behavioral: Mental Health CPR — The Mental Health CPR is a culturally adapted behavioral intervention implemented by trained Community Mental Health Workers (CMHWs). It includes interactive sessions designed to improve emotional well-being, communication between cancer survivors and caregivers, and access to mental health services. The content integrates educational videos, group discussions, and digital resources from the Community Mental Health Toolbox. The intervention also reinforces sustainability by promoting local resource use and peer support networks. Additionally, the intervention will periodically conduct mental health and distress screenings, integrate mental health promotion educational activities and skill-building activities, case management component will integrate the cancer-mental health toolbox and linkage to Psycho-Oncology Mental Health Services (MHCS) component through the PAPSI psycho-oncology mental health service program at PHSU if needed.
• Behavioral: Standard Community Health Education — The control group receives standard behavioral health education materials commonly distributed in community health settings. These materials include information on stress reduction, healthy lifestyle habits, and general mental health awareness but do not include interactive or CMHW-facilitated sessions.

Primary Outcomes

• Development of the Community Toolbox for the Mental Health CPR Intervention (18 months)
• Distress Thermometer (DT) (9 months)
• Psych-oncology mental health service referral uptake (9 months)

About This Study

The purpose of the research is to test out a combined treatment for depression where the investigators stimulate a nerve in the ear while at the same time stimulate the brain with magnets. These treatments are called transcutaneous (through the skin) auricular (ear) vagus nerve stimulation (taVNS) and transcranial (through the skull) magnetic stimulation (TMS). For participants who already have a cervical VNS device, the investigators will not change their treatment and will use this in place of the taVNS. The investigators think this combined method might treat depressive symptoms better than either alone. This study is in person at the Institute of Psychiatry in downtown Charleston on the MUSC campus. First, participants will have a screening session and then will have 6 treatment days total where participants will receive either VNS treatment alone, TMS treatment alone, or both at the same time. The treatment that participants start with will be randomized, and they will have 2 treatment days of each combination.

Design

Interventions / Regimen

• Device: Vagus Nerve Stimulation — All taVNS sessions will use the following parameters: 25Hz, 500us pulse width, on for 7 seconds, off for 12 seconds.The length of VNS treatment sessions will be identical to TMS treatment sessions and will have the same 30 minute break between each treatment session. These treatments (active or sham) will be administered to participants each treatment day, for a total of 6 different treatment days, but only 4 are active.
• Device: Transcranial Magnetic Stimulation — Participants will receive 20 trains of 30 pulses each for a total of 600 pulses per session. We will repeat this for 6 sessions each day, with at least 30 minutes between each session. These treatments (active or sham) will be administered to participants each treatment day, for a total of 6 different treatment days, but only 4 are active, so participants will get 24 TMS sessions over the course.

Primary Outcomes

• Change in Hamilton Depression Rating Scale (Through study completion, an average of 8 weeks)
• Change in Patient Health Questionnaire 9 (Through study completion, an average of 8 weeks)

About This Study

The goal of this study is to learn how accurate smartwatches are at measuring oxygen levels in patients with a condition called pulmonary hypertension. The main questions it aims to answer are: * How accurate the smartwatches are at measuring oxygen levels when the patient is sitting at rest * How accurate are smartwatches at measuring oxygen levels after exercise * How accurate are smartwatches at measuring oxygen levels after breathing a lower level of oxygen through a mask. Researchers will compare oxygen levels measured through a smartwatch with those checked through a finger probe oxygen monitor and also from a blood sample checked from the artery in the wrist to see if smartwatch oxygen measurements are similar. Participants will: -Attend the hospital once, just for a few hours to collect all the required data.

Design

Primary Outcomes

• Agreement of oxygen saturations (SpO2) measured by the wrist-worn pulse oximeter when compared with arterial blood gas oxygen saturations (SaO2) at rest (1 study visit, anticipated to be around 3 hours.)