
Study in Major Depressive Disorder With BTRX-335140 (NMRA-335140) vs Placebo
Major Depressive DisorderA proof of concept (POC) study evaluating the impact of BTRX-335140 (NMRA-335140) relative to placebo on symptoms of major depressive disorder (MDD) in adult participants with MDD and symptoms of anhedonia and anxiety following 8 weeks of double-blind treatment as assessed by the HAMD-17 Scale.

Web-based ACT to Support Parents With Children With Chronic and Developmental Conditions
Burnout SyndromePsychological Distress2 moreParents of children with a chronic disease or functional disabilities have an increased risk of stress-related distress and reduced quality of life. Internet-delivered interventions are one way to reach out to exhausted parents who may often have challenges in finding time to access face-to-face services. We developed a guided web-based Acceptance and Commitment Therapy intervention for Finnish parents of children with chronic conditions or functional disabilities. Participants (N=100) will be recruited on parent associations' Facebook groups and randomly assigned to guided web-based ACT condition and a control condition receiving psychoeducation. The guided web-based ACT condition will receive a 10-week web intervention including three remote meetings with a psychologist through the telemedicine application Doxy.me. Symptoms of burnout (SMBQ), depression (PHQ), health-related quality of life (RAND-36), mindfulness (FFMQ), general measure of psychological flexibility (CompACT) as well as the wellbeing of their child (KINDL) will be measured before (pre) and after the intervention (post), at 7-month (follow-up 1) and 10-month (follow-up 2) after the pre-measurement. In this randomized controlled trial we will investigate the outcomes and the mechanisms of change of the web-based ACTintervention. In addition, we will examine the acceptability of the web-based intervention.

Using Acceptance and Commitment Therapy for Parents of Disabled Child
Acceptance and Commitment TherapyAnxiety Depression5 moreThis study was carried out to determine the effect of ACT-based interventions applied to parents of special needs children (CSN) on their levels of psychological inflexibility, psychological resilience, depression, anxiety, stress, and caregiver burden.

Impact of Intensive Social Interaction on Post-Stroke Depression in Individuals With Aphasia
Post-stroke DepressionPost-stroke AphasiaThe present parallel-group, single-center, blinded-assessment controlled trial seeks to explore the feasibility - in terms of high completion rates - and potential efficacy of intensive communicative-pragmatic social interaction for treatment of post stroke depression in subacute aphasia. Apart from evidence of treatment feasibility, the primary hypothesis predicts significantly greater progress on self-report and clinician-rated measures of depression severity after (i) intensive communicative-pragmatic social interaction combined with standard care, compared to (ii) standard care alone.

A Study of Psilocybin for Major Depressive Disorder (MDD)
Depressive DisorderMajorOne hundred participants, ages 21 to 65, who meet Diagnostic and Statistical Manual of Mental Disorders (DSM-5) criteria for major depressive disorder (MDD) will be stratified by study site and randomized with a 1-to-1 allocation under double-blind conditions to receive a single 25 mg oral dose of psilocybin or a single 100 mg oral dose of niacin. Niacin will serve as an active placebo. The purpose of this study is to evaluate the potential efficacy of a single 25 mg oral dose of psilocybin for MDD compared to the active placebo in otherwise medically-healthy participants, assessed as the difference between groups in changes in depressive symptoms from Baseline to Day 43 post-dose.

Engaging Self-regulation Targets to Improve Mood and Weight and Understand Mechanism in Depressed...
ObesityDepressionMultimorbidity (i.e., the coexistence of 2 or more chronic conditions in an individual) is increasingly recognized as a pressing public health problem. Effective interventions targeting coexisting depression and obesity are critical given the high prevalence and worsened outcomes for patients with both conditions. ENGAGE-2 is a pilot randomized controlled trial (RCT). The objective is to investigate the outcomes and mechanisms of an integrated depression and obesity intervention that combines collaborative stepped depression treatment and evidence-based behavioral weight loss treatment. The Integrated Coaching for Better Mood and Weight-2 (I-CARE2) intervention synergistically integrates 2 proven national programs: the Program to Encourage Active and Rewarding Lives (PEARLS) for depression care and the Group Lifestyle Balance (GLB) program for weight loss and cardiometabolic risk reduction. In Phase 1 of the ENGAGE project, investigators developed a new protocol to quantify activation and connectivity of the Affective, Cognitive Control, and Default Mode brain circuits from functional magnetic resonance imaging (fMRI) among 108 depressed obese patients. Investigators implement the same fMRI protocol in this second phase of the project to examine the mechanistic role of these brain circuits as potential neural targets in treatment engagement and response in the I-CARE2 intervention. A new sample of 105 depressed obese patients are randomized in a 2:1 ratio to receive the I-CARE2 intervention (n=70) or usual care (n=35). Study assessments occur at 0 (baseline), 2 and 6 months. Investigators hypothesize that 1 or more of the neural targets under study will moderate (baseline state) and/or mediate (change at follow-up) the effect of the I-CARE2 intervention versus usual care on health behaviors (problem-solving ability, dietary intakes, physical activity) and clinical outcomes (weight loss, depression, anxiety).

A Study in People With Depression to Test the Effects of BI 1358894 on Parts of the Brain That Are...
Depressive DisorderMajorTo assess the effect of a single dose of BI 1358894 compared to placebo on BOLD responses in modulating brain processing of emotional and cognitive stimuli on the amygdala and related brain structure using fMRI in in unmedicated patients with depression.

Cultural Adaptation of the TIM&SARA Prevention Program
Depressive SymptomsDisparities between African-American and European-American youth regarding academic outcomes, mental health, and physical health exist. Depression, a very common mental health problem, plays a central role by impacting academic outcomes and cardiovascular health. Thus, a program that successfully reduces the likelihood for youths to develop depression should also reduce problems with academic outcomes and physical health and therefore reduce disparity in all three domains. Research demonstrates that European-American youth benefit more from programs preventing the development of depression than their African-American peers. Thus, the goals of this project are to (a) identify mechanisms that may result in differential program effectiveness across racial groups, and (b) adapt such a program (TIM&SARA) so youth from diverse racial backgrounds benefit similarly. Freshmen in an urban high-school will participate in TIM&SARA, fill out surveys and give biological data in saliva.

Study With Vortioxetine on Emotional Functioning in Patients With Depression
Major Depressive DisorderThe study will evaluate effectiveness of flexible dose vortioxetine 10-20 mg/day on emotional functioning in patients with MDD with an inadequate response to SSRIs/SNRIs.

The Safety and Efficacy of Psilocybin in Participants With Treatment Resistant Depression
Treatment Resistant DepressionThe Safety and Efficacy of Psilocybin in Participants with Treatment Resistant Depression