Dallas 2K: A Natural History Study of Depression (D2K)

May 2, 2025 updated by: Madhukar H. Trivedi, MD, University of Texas Southwestern Medical Center

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Estimated)

2500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • Texas
      • Dallas, Texas, United States, 75390
        • Recruiting
        • University of Texas Southwestern Medical Center
        • Principal Investigator:
          • Madhukar Trivedi, MD
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

10 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

The following group is being targeted for this observational study:

  1. Depressed patients
  2. Lifetime or Current Diagnosis of a Mood Disorder
  3. Bipolar Disorder
  4. Health Controls with NO Psychiatric Diagnosis ( For Comparison Purposes)

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
No treatment
This is an observational study. No intervention / treatment involved.
Other: Observational Study
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
10 years

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Texas Southwestern Medical Center

Collaborators

The Hersh Foundation

Investigators

  • Principal Investigator: Madhukar Trivedi, MD, University of Texas Southwestern Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 14, 2016

Primary Completion (Estimated)

September 1, 2036

Study Completion (Estimated)

September 1, 2036

Study Registration Dates

First Submitted

September 23, 2016

First Submitted That Met QC Criteria

September 27, 2016

First Posted (Estimated)

September 29, 2016

Study Record Updates

Last Update Posted (Actual)

May 4, 2025

Last Update Submitted That Met QC Criteria

May 2, 2025

Last Verified

May 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STU 112015-021

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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