Depression Paid Clinical Trials in Massachusetts

The purpose of this study is to test the effectiveness of a universal, digital, single-session intervention for youth mental health, functioning, and well-being, when implemented with Ukrainian children and adolescents. The intervention teaches well-established procedures that research has shown to be effective in helping American children calm themselves and regulate emotions, including slowed breathing and peaceful mental imagery. The intervention has not been tested previously with Ukrainian students. Participants will be provided access to this brief online program as part of the school curriculum. Students will be randomly assigned to receive the digital program either immediately or after 2 months. This 2-month lag will allow for evaluating the effectiveness of Project Calm in improving students' mental health, well-being, and self-calming skills. This will also allow for evaluating the effectiveness of such an intervention for war-exposed youths for whom these interventions may be especially helpful given the gap between these children's needs for mental health services and the very limited availability of clinicians Read Less

This is an outpatient, 2-arm, Phase 3, multicenter, randomized, double-blind, placebo-controlled study to assess the efficacy and safety of REL-1017 once daily (QD) as an adjunctive treatment of Major Depressive Disorder. Study participants will continue to take their current antidepressant therapy in addition to the study drug or placebo for the duration of the treatment period. Read Less

The goal of this research study is to train psychotherapists to administer individualized evidence-based psychotherapies in a cancer care setting to participants with elevated levels of distress due to their illness and/or treatment. The intervention will mirror clinical care in psycho-oncology in which the therapist, collaboratively with their supervisor, will choose specific components of the following evidence-based treatments to administer based on the clinical presentation of the patient and referring problem. Cognitive Behavioral Therapy (CBT) Acceptance Commitment Therapy (ACT) Mindfulness-Based Cognitive Therapy (MBCT) Mindfulness-Based Stress Reduction (MBSR) Meaning-Centered Psychotherapy (MCP) Cognitive Behavioral Therapy for Insomnia (CBT-I) CBT for other cancer-related physical symptoms like pain, fatigue, and nausea. Participation in this research study is expected to last about 26 weeks. It is expected that about 100 people and 15 therapists will take part in this research study. Read Less

Compared to civilian students in higher education, student Veterans have high rates of mental health disorders (PTSD: 40% vs. 9% and Depression: 24% vs 12.1%). As a result, Veterans with mental health disorders can be more likely to experience academic issues, such as lower enrollment rates and slower degree attainment on average. In addition, student Veterans with mental health disorders can experience substantial challenges with the already-difficult transition to the student role, with difficulties related to education planning, academic skills, and mental health management. Though many student Veterans could benefit from programming embedded in supported education interventions, current in-person VA supported education treatments are often difficult to access - or not available locally - for these Veterans. In addition, there is no widely available, VA-specific online or mobile-app based resource for students, which is a substantial gap in resources for student Veterans. The goal of this project is to develop and evaluate a comprehensive mobile app for student Veterans with mental health disorders. This intervention will use the principles of Veteran supported education research and manualized treatments to develop a personalized academic success app, VetEd, to address a variety of academic and psychiatric symptom-related educational barriers for student Veterans. Specifically, VetEd will provide a resource to (1) orient student Veterans with mental health disorders to successfully transition to the role of student as defined by their self-created educational roadmap, which will include helping students acquire (2) academic skills, (3) mental health management skills, and (4) up-to-date information on psychiatric, academic, and financial resources to help them successfully meet higher-education expectations. This overall study will involve three aims: 1) Developing a Veteran-centered educational support app to help student Veterans with mental health disorders to identify their perceived academic needs, app preferences, and evaluate Veteran-centered content; 2) Testing and iteratively revising the VetEd app (n =15) by assessing app software, content, human-computer interface, usability, satisfaction data, and preliminary exploration of changes in educational functioning (course activity completion, academic self-efficacy, and retention; and 3) Completing final revisions of the VetEd app for a future grant application of a larger RCT. This pilot project is significant and innovative in three key respects: (1) it extends services based in previous, effective supported education research to address both psychiatric and academic concerns for Veterans with mental health disorders; (2) is potentially cost-effective and easy to disseminate nationally; and (3) focuses on improving Veterans' academic functioning and quality of life is substantially different than current VA mobile app offerings. Results from this pilot project will inform the development of a Merit Review application for a larger, randomized clinical trial of VetEd with student Veterans. Read Less

The purpose of the study is to do a preliminary assessment of whether fluoxetine is effective, safe, and tolerable for the treatment of depression in adults with Down syndrome. Read Less

This is a parallel group study design. The investigators propose to compare an online, synchronous group-based yoga intervention developed for individuals with depression to an online, synchronous individualized, evidence-based behavioral therapy for depression, or Brief Behavioral Activation Treatment for Depression (BA). This study is a multi-site randomized trial of adults with clinically significant depressive symptoms. Participants (N=518) will be randomized in an equal allocation ratio (i.e., 1:1) across two intervention groups: yoga and BA. Interventions will be provided over a 12-week period and assessments will occur at baseline (week 0), week 6, week 12, week 18, and week 24. Read Less

VOICES Veterans Socials (VS) support Veterans in the community through weekly social groups. Veterans socials have the potential to improve social functioning, mental health symptoms, and create lasting social support. This project aims to evaluate and improve Veterans Socials to help older Veterans with depression by adapting materials, interviewing VS attendees, and collecting questionnaires. The goal is to improve the program based on the results for future use and research. Read Less

The purpose of this study is to assess the efficacy of an oral medication, IGC-AD1 that is a natural THC-based (Tetrahydrocannabinol) formulation, administered in micro doses, twice a day, on symptomatological Agitation, in patients with mild to severe dementia from Alzheimer's. Read Less

The goal of this clinical trial is to estimate the importance of neuroimaging in accelerated intermittent theta burst stimulation (aiTBS) for depression. Participants will receive aiTBS treatment, but they will not know if their treatment spot was found with neuroimaging or head measurements. Read Less

This study is a waitlisted randomized controlled trial. We aim to assess the level of compliance for those learning the intervention and to evaluate the impact of the practice on neuropsychological and somatic outcomes using validated scales. Enrollment into the study will be ongoing until we are able to get a sufficient sample size as described in the "Statistical Consideration" section. Upon enrollment and randomization, surveys will be administered to both the intervention and control groups at four time-points: baseline, T2, T3, and T4, each of which are 6 weeks apart. Compliance data will be collected weekly for 12 weeks for both groups. Read Less

The goal of this interventional double-blind study is to demonstrate the safety and efficacy of PRISM neurofeedback training within an MDD Anhedonia sample. The main questions it aims to answer are: what clinical profile / symptoms-based biomarkers scores can be used by clinics to administer PRISM therapy in conjunction with standard care of therapy? What are the initial guidelines for integrating PRISM neurofeedback training for MDD therapy with MDD Anhedonia? Participants will be randomly assigned to one of two arms, Active, or Sham. During the study, participants will perform the following: Complete clinical assessments using questionnaires, an MRI scan, and tasks that probe reward responsivity, learning, and motivation. Perform 15 (+/-3) neurofeedback training sessions (performed twice a week on nonconsecutive days for about 2 months). Complete the same clinical assessments, post-NF training MRI scan, and tasks same as in the screening/baseline stage. Researchers will compare the sham and treatment arm to evaluate if the neurofeedback effect reduced MDD symptoms in MDD patients with Anhedonia. Read Less

This is a longitudinal study where individual with Major Depressive Disorder (MDD) will be monitored for 12 weeks. The study aims to develop an objective, sensor-based, algorithm able to detect the presence of depression as well as predict treatment response. Measurement-based treatment is considered optimal and the development of a valid passive, objective, behavioral and biological assessment of depressive symptoms that does not rely on clinician interviews will improve monitoring and ultimately improve treatment significantly. Read Less