Actively Recruiting
Dallas 2K: A Natural History Study of Depression
Led by University of Texas Southwestern Medical Center · Updated on 2025-05-04
2500
Participants Needed
1
Research Sites
1054 weeks
Total Duration
On this page
Sponsors
U
University of Texas Southwestern Medical Center
Lead Sponsor
T
The Hersh Foundation
Collaborating Sponsor
AI-Summary
What this Trial Is About
The primary objective of this initiative is to implement a prospective study that will allow us to identify and validate biosignatures of response to treatments for depression and depression outcome (using an integrated array of participant specific data: socio-demographic, lifestyle, clinical and behavioral assessments, fluid-based biomarkers, genomics, neuroimaging, EEG, and cell-based assays) in a longitudinal cohort of subjects with elevated symptoms of a depressive disorder. Symptom remission across various treatment options will be assessed using questionnaires for symptom changes, antidepressant treatment tolerability and overall quality of life. Other outcomes generated from this study will include rate of change in quantitative measures of brain function, of depression relevant brain regions correlated with systems-levels behavior and other functional neuro-circuitry MRI measures. Rate of change of specified biochemical biomarkers will also be assessed. Integration of these measures will provide an unmatched understanding into the mechanisms of depression and hold tremendous promise for better disease treatment and associated outcomes.
CONDITIONS
Official Title
Dallas 2K: A Natural History Study of Depression
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male and female youth or adults aged 10 and older of any race or ethnicity
- Ability to speak, read, and understand English (parent or guardian may use Spanish for minors)
- Lifetime or current diagnosis of a mood disorder based on a semi-structured interview
- Adults 18 and older must provide written informed consent
- For youth younger than 18, a parent or legal guardian must provide written informed consent and the child or teen must provide written assent
- Healthy controls aged 10 and older without psychiatric diagnosis may also participate with the same consent requirements
You will not qualify if you...
- History of schizophrenia, schizoaffective disorder, or chronic psychotic disorders
- Diagnosis of HIV, hepatitis B, or hepatitis C (HIV testing not required)
- Unable to provide a stable home address and contact information
- Conditions that, in the investigator's opinion, make participation unadvisable (e.g., cognitive impairment, unstable medical condition, intoxication, active psychosis)
- Immediate hospitalization required for psychiatric disorder or suicidal risk
- Healthy controls with a current or lifetime mood disorder diagnosis
- Healthy controls who meet any exclusion criteria of the main study
AI-Screening
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Trial Site Locations
Total: 1 location
1
University of Texas Southwestern Medical Center
Dallas, Texas, United States, 75390
Actively Recruiting
Research Team
A
Afrida Khurshid, BA
CONTACT
S
Sangita Sethuram, MBA, CCRP
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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