The epidemiology of major depressive disorder: results from the National Comorbidity Survey Replication (NCS-R).
Ronald C Kessler, Patricia Berglund, Olga Demler...
https://pubmed.ncbi.nlm.nih.gov/12813115Actively Recruiting
Age: 10Years +
All Genders
Healthy Volunteers
ID02919280
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
N/A
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
Researchers are conducting a 10-year natural history study called Dallas 2K to understand factors affecting depression treatment response and outcomes. This study involves 2,500 participants with elevated depressive symptoms, collecting a wide range of data including socio-demographic, lifestyle, clinical, behavioral, biological, neurophysiological, and neuroimaging information. The goal is to identify and validate biosignatures linked to treatment response, remission, recurrence, and relapse in depressive disorders. This observational study does not provide any medication or treatment but collects data through participant-rated and clinician-rated assessments, biospecimen collections, EEG, MRI, and optional mobile health monitoring via phone apps or wristbands. Assessments occur regularly with surveys monthly, and MRI, EEG, biospecimen collection, cognitive tasks, and self-report assessments up to four times a year. The schedule adapts to participant characteristics to ensure balanced data. Participants will engage in repeated evaluations over the 10 years, including brain imaging, EEG scans, and fluid biomarker analyses from blood, saliva, stool, and urine. Questionnaires will track depression symptoms and quality of life. Youth participants will complete age-appropriate questionnaires with support as needed. The study measures longitudinal changes in depression severity and related brain and biological functions while monitoring participant well-being throughout the study.
CONDITIONS
Brief Title
Dallas 2K: A Natural History Study of Depression
Who Can Participate
Age: 10Years +
All Genders
Healthy Volunteers
Eligibility Criteria
You may qualify if you...
- Male and female participants aged 10 years and older of any race or ethnicity
- Ability to speak, read, and understand English (parents or guardians of minors may speak English or Spanish for consent)
- Lifetime or current diagnosis of a mood disorder based on a diagnostic interview
- Adults 18 and older must provide written informed consent; minors must have parent or guardian consent and provide written assent
- Healthy controls without psychiatric diagnosis may also participate with similar age and language requirements
You will not qualify if you...
- History of schizophrenia, schizoaffective disorder, or chronic psychotic disorders
- Diagnosis of HIV or hepatitis B or C (testing not required)
- Inability to provide a stable home address and contact information
- Any condition that would make study participation unsafe or limit assessments, such as cognitive impairment, unstable medical condition, intoxication, or active psychosis
- Immediate hospitalization required for psychiatric disorder or suicidal risk
- Healthy controls with lifetime or current mood disorder or any main study exclusion criteria
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Diagnostic Evaluation
Duration - Initial baseline assessments at enrollment
Participants undergo assessments including clinician rated and participant rated questionnaires, cognitive behavioral tasks, and collection of biological samples to evaluate depression and related factors.
1 baseline visit (in-person)
Long-term Monitoring
Duration - Up to 10 years
Participants are observed over 10 years with regular assessments including monthly surveys, MRI and EEG scans, biospecimen and stool sample collections, and cognitive and behavioral evaluations to track depression severity and related outcomes.
Monthly surveys 12 times a year; up to 4 visits per year each for MRI, EEG, biospecimen, stool collection, and cognitive behavioral tasks; 4 visits per year for extensive assessments
Trial Site Locations
Total: 1 location
1
University of Texas Southwestern Medical Center
Dallas, Texas, United States, 75390
Actively Recruiting
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Research Team
A
Afrida Khurshid, BA
S
Sangita Sethuram, MBA, CCRP
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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Madhukar H Trivedi, A John Rush, Stephen R Wisniewski...
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Bernard S Bloom
https://pubmed.ncbi.nlm.nih.gov/15293766Defining anhedonia subgroups using the dimensional anhedonia rating scale in active depression: Findings from the Texas resilience against depression study.
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https://pubmed.ncbi.nlm.nih.gov/41401669