Dallas 2K: A Natural History Study of Depression

Recruiting

• Conditions: Depression, Bipolar; Depression
• Interventions: Other: Observational Study

• Registration Number: NCT02919280
• Lead Sponsor: University of Texas Southwestern Medical Center

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.

Detailed Description

D2K is a 10-year natural history, longitudinal, prospective study of a cohort of 2,500 participants that will help uncover the socio-demographic, lifestyle, clinical, psychological, and neurobiological factors that contribute to antidepressant treatment response: remission, recurrence, relapse and individual outcomes in depressive disorders. As this is an exploratory study, we will assess a comprehensive panel of carefully selected participant specific parameters: socio-demographic (age, sex, gender, race, ethnicity, economic); life habits (physical activity, substance use); clinical (medical history, anxious depression, early life trauma), biological (biomarkers in blood, saliva, urine, stool), behavioral (cognitive, emotional), neurophysiological (EEG), and neuroimaging (magnetic resonance imaging; MRI) with the goal of developing the most robust predictive models of depression treatment response and of outcomes.

Clinician rated assessments, participant rated assessments, blood, saliva, stool, and urine collection, EEG, and MRI will be performed during the duration of the study. An optional m-health study may be collected continuously via a phone application and/or wristband over the course of the study. With this said, due to the nature of the protocol and the large number of research participants, we expect some appointments that include procedures and assessments to be missed within an expected study time frame. We will attempt to complete any missed appointments at the next scheduled visit. For the purposes of this study, missed procedures and/or assessments are not considered protocol deviations. In addition, the schedule of assessments to be completed will vary from time to time within this longitudinal study to help balance the data between age, sex, biological gender, gender identity, sexual orientation, gender expression, and diagnosis breakdown of our enrolled participants for data analyses.

The schedule of assessments will NOT exceed the following:

1. Monthly Surveys: 12 times a year

2. MRI: up to 4 times a year

3. EEG: up to 4 times a year

4. Biospecimen collection: up to 4 times a year

5. Cognitive Behavioral Tasks: up to 4 times a year

6. Extensive Self-report and Clinician rated assessments: 4 times a year

7. Stool Sample collection: up to 4 times a year

8. Optional M-health: Duration of the study (starting from Baseline) Participants will be compensated based on the study activity they complete and will not exceed the total amount (per year) that is approved by the IRB. No study procedures will be conducted until signed informed consent has been obtained from the participant. Details regarding informed consent procedures are included in section 8.

Procedures specific to youth 17 years old or younger: Participants will complete the questionnaires that have been normed and validated to their age with the assistance of study staff. Forms may also be completed by participant's parent(s)/guardian(s)/LAR as needed.

Study Timeline

• Study Start: 2016-06-14
• Study First Submitted: 2016-09-23
• Study First Submitted QC: 2016-09-27
• Study First Posted: 2016-09-29
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-02
• Last Update Posted: 2025-05-04
• Primary Completion: 2036-09
• Study Completion: 2036-09

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 2500

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
No treatment	Observational Study	This is an observational study. No intervention / treatment involved.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Comparison of Longitudinal changes in functioning as measured by quantitative electroencephalography (EEG) in patients with severe depression.	10 years
Comparison of Longitudinal changes in fluid based biomarkers as measured by proteomic methods in patients with severe depression.	10 years
Comparison of Longitudinal changes in fluid based biomarkers as measured by genomic methods in patients with severe depression.	10 years
Comparison of Longitudinal changes in functioning as measured by Magnetic Resonance imaging in patients with severe depression	10 years
Comparison of Longitudinal changes in fluid based biomarkers as measured by metabolomics methods in patients with severe depression.	10 years
Comparison of Longitudinal changes in fluid based biomarkers as measured by transcriptomic methods in patients with severe depression.	10 years
Comparison of Longitudinal changes in fluid based biomarkers as measured by epigenomic methods in patients with severe depression.	10 years

Trial Locations

Locations (1)

University of Texas Southwestern Medical Center; 🇺🇸 Dallas, Texas, United States