Dallas 2K: A Natural History Study of Depression

Part of paid clinical trials in Dallas, Texas.

Sponsor
University of Texas Southwestern Medical Center
Study ID
NCT02919280
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
10 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • Observational Study — OTHER
    The Dallas 2K is a 10-year natural history, longitudinal, prospective study of a cohort of 2,500 participants. There is no medication or non-medication treatment or intervention provided by this study.

Study Details

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.

Key Dates

Start date
Jun 14, 2016
Status verified
May 2025
Primary completion
Sep 30, 2036
Completion
Sep 30, 2036

Study Design

Enrollment
2,500 participants (estimated)

Arms

  • Arm: No treatment
    This is an observational study. No intervention / treatment involved.

Primary Outcome Measure

Longitudinal changes in depression severity of subjects with elevated symptomatology on Patient Health Questionnaire (PHQ-9) for non-psychotic depressive disorders. [ Time Frame: 10 years ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of Texas Southwestern Medical CenterDallasTexas75390
Sangita Sethuram, MBA, CCRP
[email protected]
214-648-4357
Madhukar Trivedi, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Dallas, TX

By condition
Depression
By specialty
PsychiatryMental healthBehavioral health
By research site
University of Texas Southwestern Medical Center· Dallas, TX

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