Natural history study of depression and bipolar disorder

Dallas 2K: A Natural History Study of Depression

This study is trying to understand how depression and bipolar disorder change over time by looking at different factors in 2,500 people to see what helps them respond better to treatments.

Quick facts

• Study type: Observational
• Enrollment: 2500 (estimated)
• Ages: 10 Years and up
• Sex: All
• Sponsor: University of Texas Southwestern Medical Center (other)
• Locations: 1 site (Dallas, Texas)
• Trial ID: NCT02919280 on ClinicalTrials.gov

What this trial studies

This initiative aims to conduct a 10-year observational study involving 2,500 participants to identify and validate biosignatures related to treatment responses for depression and bipolar disorder. The study will gather a wide array of participant-specific data, including socio-demographic, lifestyle, clinical, and neurobiological factors, to develop predictive models for treatment outcomes. Participants will undergo various assessments, including questionnaires, blood and biomarker collection, EEG, and MRI, to evaluate changes in symptoms and brain function over time. The study also includes an optional mobile health component for continuous data collection.

Who should consider this trial

Good fit: Ideal candidates include individuals aged 10 and older with a current or lifetime diagnosis of a mood disorder, as well as healthy controls without psychiatric diagnoses.

Not a fit: Patients who do not have a mood disorder or those who are unable to participate in the required assessments may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved understanding and treatment of depression and bipolar disorder, enhancing patient outcomes.

How similar studies have performed: Other studies have shown promise in identifying biomarkers for depression treatment response, but this comprehensive approach is relatively novel.

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 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. 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:

1. History of schizophrenia, schizoaffective disorders or chronic psychotic disorders based upon a semi-structured diagnostic interview.
2. Diagnosis of human immunodeficiency virus (HIV) or hepatitis B or C (human immunodeficiency virus (HIV) testing is not required for this study).
3. Unable to provide a stable home address and contact information.
4. 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.
5. 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:

1. A lifetime or a current history of a mood disorder based upon a semi-structured diagnostic interview.
2. Meets any exclusion criteria as part of the main D2K study interview.

Where this trial is running

Dallas, Texas

• University of Texas Southwestern Medical Center — Dallas, Texas, United States (RECRUITING)

Study contacts

• Principal investigator: Madhukar Trivedi, MD — University of Texas Southwestern Medical Center
• Study coordinator: Afrida Khurshid, BA

Conditions: Depression, Depression, Bipolar, healthy control, depression, bipolar