NCT02919280

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,500

participants targeted

Target at P75+ for all trials

Timeline
124mo left

Started Jun 2016

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress49%
Jun 2016Sep 2036

Study Start

First participant enrolled

June 14, 2016

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

September 23, 2016

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 29, 2016

Completed
19.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2036

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2036

Last Updated

May 4, 2025

Status Verified

May 1, 2025

Enrollment Period

20.2 years

First QC Date

September 23, 2016

Last Update Submit

May 2, 2025

Conditions

DepressionDepression, Bipolar

Keywords

healthy controldepressionbipolar

Outcome Measures

Primary Outcomes (1)

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

    10 years

Secondary Outcomes (7)

  • Comparison of Longitudinal changes in functioning as measured by Magnetic Resonance imaging in patients with severe depression

    10 years

  • 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 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

  • +2 more secondary outcomes

Study Arms (1)

No treatment

This is an observational study. No intervention / treatment involved.

Other: Observational Study

Interventions

Observational StudyOTHER

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.

No treatment

Eligibility Criteria

Age10 Years+
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Texas Southwestern Medical Center

Dallas, Texas, 75390, United States

RECRUITING

Related Publications (6)

  • Kessler RC, Berglund P, Demler O, Jin R, Koretz D, Merikangas KR, Rush AJ, Walters EE, Wang PS; National Comorbidity Survey Replication. The epidemiology of major depressive disorder: results from the National Comorbidity Survey Replication (NCS-R). JAMA. 2003 Jun 18;289(23):3095-105. doi: 10.1001/jama.289.23.3095.

    PMID: 12813115BACKGROUND

  • Rush AJ, Trivedi MH, Wisniewski SR, Nierenberg AA, Stewart JW, Warden D, Niederehe G, Thase ME, Lavori PW, Lebowitz BD, McGrath PJ, Rosenbaum JF, Sackeim HA, Kupfer DJ, Luther J, Fava M. Acute and longer-term outcomes in depressed outpatients requiring one or several treatment steps: a STAR*D report. Am J Psychiatry. 2006 Nov;163(11):1905-17. doi: 10.1176/ajp.2006.163.11.1905.

    PMID: 17074942RESULT

  • Trivedi MH, Greer TL, Grannemann BD, Church TS, Somoza E, Blair SN, Szapocznik J, Stoutenberg M, Rethorst C, Warden D, Ring KM, Walker R, Morris DW, Kosinski AS, Kyle T, Marcus B, Crowell B, Oden N, Nunes E. Stimulant reduction intervention using dosed exercise (STRIDE) - CTN 0037: study protocol for a randomized controlled trial. Trials. 2011 Sep 19;12:206. doi: 10.1186/1745-6215-12-206.

    PMID: 21929768RESULT

  • Trivedi MH, Rush AJ, Wisniewski SR, Nierenberg AA, Warden D, Ritz L, Norquist G, Howland RH, Lebowitz B, McGrath PJ, Shores-Wilson K, Biggs MM, Balasubramani GK, Fava M; STAR*D Study Team. Evaluation of outcomes with citalopram for depression using measurement-based care in STAR*D: implications for clinical practice. Am J Psychiatry. 2006 Jan;163(1):28-40. doi: 10.1176/appi.ajp.163.1.28.

    PMID: 16390886RESULT

  • Bloom BS. Prevalence and economic effects of depression. Manag Care. 2004 Jun;13(6 Suppl Depression):9-16.

    PMID: 15293766RESULT

  • Chin Fatt CR, Minhajuddin A, Goodman LC, Vasu S, Mayes TL, Sethuram S, Trombello JM, Hughes JL, Greer TL, Foster JA, Trivedi MH. Defining anhedonia subgroups using the dimensional anhedonia rating scale in active depression: Findings from the Texas resilience against depression study. J Psychiatr Res. 2026 Feb;193:480-486. doi: 10.1016/j.jpsychires.2025.12.023. Epub 2025 Dec 11.

    PMID: 41401669DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Establish a D2K biospecimen resource consisting of stool, blood, plasma, serum, PBMCs, buffy coat, RNA, and saliva collected from participants at baseline and at follow-up visits, as a platform for translational research into biochemical and molecular characterization of depression.

MeSH Terms

Conditions

DepressionBipolar Disorder

Interventions

Observation

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehaviorBipolar and Related DisordersMood DisordersMental Disorders

Intervention Hierarchy (Ancestors)

MethodsInvestigative Techniques

Study Officials

  • Madhukar Trivedi, MD

    University of Texas Southwestern Medical Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Afrida Khurshid, BA

CONTACT

(214) 998 - 5877TRAD@UTSouthwestern.edu

Sangita Sethuram, MBA, CCRP

CONTACT

(214) 648 - 4357TRAD@UTSouthwestern.edu

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

September 23, 2016

First Posted

September 29, 2016

Study Start

June 14, 2016

Primary Completion (Estimated)

September 1, 2036

Study Completion (Estimated)

September 1, 2036

Last Updated

May 4, 2025

Record last verified: 2025-05

Locations

US(1)