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.

    Behavioral Activation Teletherapy

    The Behavioral Activation Teletherapy (BAT) study is currently recruiting English and Spanish-speaking participants ages 18-64. The BAT intervention is targeted to increase physical activity for individuals with depression.

    Study participation will last approximately 3 months and consist of:

    • 13 visits: 2 at clinic and 11 remote teletherapy sessions.
    • Questionnaires completed remotely prior to teletherapy sessions and occasionally questionnaires after session.
    • Wearing a Fitbit provided by the study to monitor physical activity.
    • Tracking weekly activity in provided packet.

    To learn more about this study, visit our 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.

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

    UNIKET is a study to develop a baseline of normal targets for mood disorder identification that can inform better treatment.

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

    Esketamine Administered as Monotherapy

    The TRD4005 study is investigating the efficacy of each individual dose of esketamine nasal spray, 56mg and 84mg, compared with placebo nasal spray in improving depressive symptoms in participants with treatment-resistant depression. 

    This study has 4 phases: screening, double-blind treatment, open-label treatment/observation, and follow-up. 

    1. Screening Phase (4-7 weeks): Participant eligibility is confirmed through study tests and procedures. 
    2. Double-Blind Treatment Phase (~4 weeks): Participants are randomized to 56mg esketamine nasal spray or 84mg esketamine nasal spray or placebo nasal spray in a 1:1:2 ratio. 
    3. Open-Label Treatment/Observation (Up to 12 weeks): Participation is optional and all participants who agree to participate will receive esketamine nasal spray. 
    4. Follow-Up Visit: A visit at the clinic approximately 4 weeks after final dose of study drug. 

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

    Study to Assess the Efficacy and Safety of Adjunctive NBI-1065845 in Adults With Major Depressive Disorder (MDD)

    SAVITRI is a randomized, double-blind, placebo-controlled study to assess the efficacy and safety of adjunctive NBI-1065845 in adults with major depressive disorder.

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

    Phase 2 Study of NV-5138 in Adults With Treatment Resistant Depression

    SUPERNUS is investigating the efficacy of the investigational drug NV-5138 used as an adjunctive treatment to oral antidepressant medication(s), compared with placebo for the treatment of treatment-resistant depression (TRD). 

    There are 3 periods in the study: 

    1. Screening Period (up to 6 weeks): Three clinic visits to confirm participant eligibility. 
    2. Double-Blind Treatment Period (Approximately 5 weeks): Participants are randomized in a 1:1 ratio to receive investigational drug NV-5138 or placebo and attend 6 weekly clinic visits. 
    3. Follow-Up Period (approximately 4 weeks): Participants are contacted via telephone to complete a few safety assessments with study team after approximately 4 weeks after stopping the investigational drug. 

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

    Study to Evaluate the Efficacy and Safety of Once-Weekly Oral NBI-1065846 in the Treatment of Anhedonia in MDD 

    TERPSIS is a randomized, double-blind, placebo-controlled, proof-of-concept study to evaluate the efficacy and safety of once-weekly oral NBI-1065846 in the treatment of anhedonia in major depressive disorder.

    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.

    Mood Disorders Research

    Substance Abuse 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. 

      Innovatively Increasing PCP Prescribing of Buprenorphine: Measurement Based Care and Integrated Electronic Solution (MBC4OUD)

      This trial examines the increase in primary-care provider prescription of buprenorphine.

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

      Surmounting Withdrawal to Initiate Fast Treatment With Naltrexone (SWIFT)

      This trial explores fast treatment with naltrexone for opioid withdrawal to improve the real-world effectiveness of injection naltrexone for opioid use disorder.

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

      rTMS for Stimulant Use Disorders (STIMULUS)

      This trial examines the use of rTMS for stimulant use disorder treatment.

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

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

      A randomized, placebo-controlled trial of extended-release naltrexone and monthly extended-release buprenorphine for the treatment of cocaine use disorder.

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

      Strategies to Enhance Recruitment and Retention of Black Individuals Into Clinical Trials for Substance Use Disorders (I-DREM)

      An observational study exploring strategies to enhance recruitment and retention of African American/black individuals in clinical trials through the development of a research engagement manual.

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

      Monthly Injectable BUP for MA Use Disorder (MURB) Trial 

      A randomized, double-blind, placebo-controlled trial of monthly injectable buprenorphine for the treatment of methamphetamine use disorder.

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

      Remote Methadone Ingestion Surveillance Trial (RMIST)

      A remote methadone ingestion surveillance trial to treat opioid use disorder during and after the covid-19 pandemic.

      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.

        Characterizing Inflammatory Profiles and Suicidal Behavior in Adolescents

        An observational study to understand the role of inflammatory dysfunction of suicidal behavior to guide risk identification and treatments.

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

        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)

        A double-blind randomized controlled trial that examines an acute-course of ketamine versus midazolam to treat the reoccurence of suicidality in adolescents.

        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.