Clinical Trials

Solving Depression, Saving Tomorrows

For more than two decades, Dr. Madhukar Trivedi and his colleagues at UT Southwestern Medical Center have conducted cutting-edge research to improve the treatment of depression, including the largest study-to-date examining appropriate treatment sequences for depression.

Dr. Trivedi meeting with a patient
Mood Disorders Research

Depression Trials

Depression is a major health challenge affecting more than 300 million people globally. Research suggests that 1 in 6 people will experience depression in their lifetime with an 18% increase over the past decade. Of the more than 17 million individuals diagnosed with depression living in the United States, more than 5 million experience treatment-resistant depression.  Many of our trials focus on those individuals struggling with treatment-resistant depression.

    A Phase III, Multicenter, Randomised, Double-Blind, Controlled Study to Investigate the Efficacy, Safety, and Tolerability of Two Initial Administrations of COMP360 in Participants with Treatment-Resistant Depression (COMP006)

    To learn more about this study, visit the clinicaltrials.gov study page.

    Dallas 2K

    The Dallas 2K study is a long-term study researching the biological mechanisms of depression and antidepressant treatment response. The D2K study comprises 2,000 participants, over 10 years of age, with a lifetime or current diagnosis of a mood disorder.

    Researchers will collect socio-demographic and clinical data, cognitive and psychological assessments, fluid-based biomarkers (blood, urine, saliva), neuroimaging, and EEG. With this information, we hope to create a biosignature to ease treatment selection or identify moderators of response or non-response to treatments in patients with depression. No interventions or treatments will be conducted in the course of the project. 

    To learn more about this study, visit our clinicaltrials.gov study page.

    A Randomized, Double-Blind, Multienter, Parallel-Group, Placebo-Controlled Study to Evaluate the Efficacy, Safety, and Tolerability of Aticaprant 10 mg as Adjunctive Therapy in Adult Participants with Major Depressive Disorder (MDD) with Moderate-to-Severe Anhedonia and Inadequate Response to Current Antidepressant Therapy (MDD3002)

    To learn more about this study, visit the clinicaltrials.gov study page.

    An Open-Label, Long-Term, Safety and Efficacy Study of Aticaprant as Adjunctive Therapy in Adult and Elderly Participants with Major Depressive Disorder (MDD) (MDD3003)

    To learn more about this study, visit the clinicaltrials.gov study page.

    Studying the Health of Asians to Advance Knowledge, Treatments, and Interventions for Depression (SHAKTI)

    We are currently recruiting English-speaking individuals aged 10 years and older who self-identify as Asian and/or Pacific Islander (e.g., East Asian, South Asian, Southeast Asian, Southwest Asian, Central Asian, Oceanian, Polynesian, Micronesian, Melanesian). 

    Researchers will collect socio-demographic and clinical data, cognitive and psychological assessments, fluid-based biomarkers (blood, urine, saliva, stool), neuroimaging, and EEG. Participants may attend up to 4 clinic visits per year, and some study procedures may be done remotely. 

    To learn more about this study, visit our clinicaltrials.gov study page.

    Elucidating the neurocircuitry of irritability with high-field neuroimaging to identify novel therapeutic targets

    To learn more about this study, visit our clinicaltrials.gov study page.

    UTSW Depression Cohort: A Longitudinal Study of Depression

    The UTSW Depression Cohort is a longitudinal observational study to describe the longitudinal course of illness and real-world treatment outcomes for depressed patients receiving routine care from their providers.

    To learn more about this study, visit our clinicaltrials.gov study page.

    Efficacy and Safety of Bupropion Hydrobromide in Adolescents and Children with Major Depressive Disorder

    To learn more about this study, visit our clinicaltrials.gov study page.

    Mood Disorders Research

    Substance Use Trials

    Substance use, particularly the use of stimulants and opioids in the fourth wave of the opioid epidemic, are a major public health problem. Research is needed to develop new substance use disorder treatments and to determine how to best broadly disseminate the treatments that are currently available and effective. Dr. Madhukar Trivedi leads the Clinical Trials Network Big South/ West Network Node to investigate novel interventions to improve outcomes for substance use disorders. 

      Extended-Release Naltrexone and Monthly Extended-Release Buprenorphine for Cocaine Use Disorder (CURB-2)

      To learn more about this study, visit the clinicaltrials.gov study page.

      Randomized, Double-Blind, Active Placebo-Controlled Trial of Ketamine for Methamphetamine Use Disorder

      Trial of Naltrexone/Bupropion for the Treatment of Methamphetamine Use Disorder

      To learn more about this study, visit the clinicaltrials.gov study page.

      Observational Longitudinal Study of Individuals with Stimulant Use Disorder: Research and Development of a Biosignature (STIM-RAD)

      To learn more about this study, visit our clinicaltrials.gov study page.

      Mood Disorders Research

      Resilience and Suicidal Ideation Trials

      Our priorities at the CDRC include studying biomarkers related to youth suicide risk and more effective ways to treat suicidal ideation and behavior. To further this goal of reducing adolescent suicidality, our team has received two grants from the American Foundation for Suicide Prevention (AFSP) and the National Institute of Mental Health (NIMH). Because depression often begins early in life, our goal is to proactively study the disease in young people to ultimately prevent or minimize its impact population-wide.

        Resilience Against Depression Study

        A longitudinal observational study that follows participants ages 10 and older to uncover the socio-demographic, lifestyle, clinical, psychological, and biological factors associated with depression and bipolar disorder.

        To learn more about this study, visit our clinicaltrials.gov study page.

        Ketamine Versus Midazolam for Recurrence of Suicidality in Adolescents (TASK)

        To learn more about this study, visit our clinicaltrials.gov study page.

        Texas Youth Depression and Suicide Research Network

        A state-funded multi-center research initiative to examine healthcare systems and assess the mental health care received by children and adolescents in the state of Texas.

        To learn more about this study, visit our clinicaltrials.gov study page.

        Educating About Suicidality

        Dr. Madhukar Trivedi interviews the CDRC's own Faculty, and pediatric specialist, Dr. E. Rabia Ayvaci about suicidality risk in adolescents as part of our CDRC Townhall.

        Find out more
        Drs. Ayvaci and Trivedi

        Real People. Real Research.

        As part of Suicide Prevention Month, the AFSP team coordinated a series of awareness events to shine a light on the research and the reasons why we do the work.

        Find out more
        Dr. Ayvaci presenting

        Participating in Purpose

        For more than two decades, Dr. Madhukar Trivedi and his colleagues at UT Southwestern Medical Center have conducted cutting-edge research to improve the treatment of depression, including the largest study-to-date examining appropriate treatment sequences for depression.

        Find out more
        Dr. Trivedi's Clinical Research interview

        Statewide Initiatives

        Be part of the great impact we're having on science and medical care across the globe.

        To better understand the areas of greatest impact, we have identified and partnered with schools, community organizations, and healthcare systems on initiatives to improve the diagnosis and treatment of mood disorders and enhance suicide prevention efforts.