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.

If you are interested in participating, or know someone who would be, please complete this form.

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.

If you are interested in participating, or know someone who would be, please complete this form.

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.

If you are interested in participating, or know someone who would be, please complete this form, or CDRC@UTSouthwestern.edu. 

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

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.

If you are interested in participating, or know someone who would be, please complete this form.

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. 

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.

If you are interested in participating, or know someone who would be, please complete this form.

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.

If you are interested in participating, or know someone who would be, please complete this form.

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.

If you are interested in participating, or know someone who would be, please complete this form.

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.

If you are interested in participating, or know someone who would be, please complete this form.

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.

If you are interested in participating, or know someone who would be, please complete this form.

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.

If you are interested in participating, or know someone who would be, please complete this form.

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 Black (e.g., African American) individuals in clinical trials through the development of a research engagement manual.

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

If you are interested in participating, or know someone who would be, please complete this form.

Monthly Injectable BUP for MA Use Disorder (MURB) Trial 

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

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

If you are interested in participating, or know someone who would be, please complete this form.

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.

If you are interested in participating, or know someone who would be, please complete this form.

Texas Youth Depression and Suicide Research Network

A state-funded multi-center research initiative to examine health care 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.

If you are interested in participating, or know someone who would be, please complete this form.

Resilience Against Depression Study

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

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

If you are interested in participating, or know someone who would be, please complete this form.

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 reoccurrence of suicidality in adolescents.

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

If you are interested in participating, or know someone who would be, please complete this form.