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Dallas 2K: A Natural History Study of Depression

NCT02919280 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 2500

Last updated 2025-05-04

No results posted yet for this study

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.

Conditions

Interventions

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.

Sponsors & Collaborators

  • The Hersh Foundation

    collaborator UNKNOWN

  • University of Texas Southwestern Medical Center

    lead OTHER

Principal Investigators

  • Madhukar Trivedi, MD · University of Texas Southwestern Medical Center

Eligibility

Min Age
10 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2016-06-14
Primary Completion
2036-09-30
Completion
2036-09-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02919280 on ClinicalTrials.gov