NCT02919280Active, not recruiting
Dallas 2K: A Natural History Study of Depression
Source: ClinicalTrials.gov · Last updated 15 Sept 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Study type
- Observational
- Enrollment
- 2500 (estimated)
- First submitted
- 23 Sept 2016
- Start date
- 14 Jun 2016
- Primary completion date
- Sept 2036
- Lead sponsor
- University of Texas Southwestern Medical Center
- Diseases
- Bipolar disorder
- NCT number
- NCT02919280
What you commit to
- Study type: Observational
- Planned participants: 2500
- From 14 Jun 2016 to the primary completion date, Sept 2036
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Criteria the registry did not label
- Criteria for Inclusion of participants:
- A potential participant will be eligible for participation in this study if the following criteria are met:
- Male and female adult or youth aged 10 and older of any race or ethnicity.
- 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.
- A lifetime or a current diagnosis of a mood disorder based upon a semi-structured diagnostic interview.
- 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.
- Male and female adult or youth aged 10 and older of any race or ethnicity.
- 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.
- 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.
- Criteria for Exclusion of Participants
- A potential participant will NOT be eligible for participation in this study if any of the following criteria are met:
- History of schizophrenia, schizoaffective disorders or chronic psychotic disorders based upon a semi-structured diagnostic interview.
- Diagnosis of human immunodeficiency virus (HIV) or hepatitis B or C (human immunodeficiency virus (HIV) testing is not required for this study).
- Unable to provide a stable home address and contact information.
- Has any condition for which, in the opinion of the investigator or designee, study participation would not be in their best interest (including but not limited to cognitive impairment, unstable general medical condition, intoxication, active psychosis) or that could prevent, limit, or confound the protocol-specified assessments.
- Requires immediate hospitalization for psychiatric disorder or suicidal risk as assessed by a licensed study clinician.
- Eligibility for Healthy Controls
- A potential Healthy Control participant will NOT be eligible for participation in this study if any of the following criteria are met:
- A lifetime or a current history of a mood disorder based upon a semi-structured diagnostic interview.
- Meets any exclusion criteria as part of the main D2K study interview.
Age in the registry: 10 years to - · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University of Texas Southwestern Medical Center Coordinator of this site? Confirm its status | Dallas | United States | Unknown status |
Related publications
This page is information, not medical advice. Discuss any trial with your doctor.