NCT02919280 Dallas 2K: A Natural History Study of Depression
| NCT ID | NCT02919280 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Texas Southwestern Medical Center |
| Condition | Depression |
| Study Type | OBSERVATIONAL |
| Enrollment | 2,500 participants |
| Start Date | 2016-06-14 |
| Primary Completion | 2036-09 |
Trial Parameters
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Brief Summary
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.
Eligibility Criteria
Criteria for Inclusion of participants: A potential participant will be eligible for participation in this study if the following criteria are met: 1. Male and female adult or youth aged 10 and older of any race or ethnicity. 2. Ability to speak, read, and understand English. However, the parent(s) or legal guardians of minors may either speak English or Spanish as the consenting process can be conducted bilingually. 3. A lifetime or a current diagnosis of a mood disorder based upon a semi-structured diagnostic interview. 4. Adults age 18 and older must be able to provide written informed consent; for youth younger than age 18, a parent or legal guardian must provide written informed consent, and the child or teen must provide written informed assent. Eligibility for Healthy Controls For comparison purposes, potential health control participants who do NOT have a psychiatric diagnosis will be enrolled as part of the healthy control arm of this study. 1. Male and female adult or youth a
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