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

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ClinicalTrials.gov Identifier: NCT02919280
Recruitment Status : Recruiting
First Posted : September 29, 2016
Last Update Posted : May 24, 2021
Sponsor:
Collaborator:
The Hersh Foundation
Information provided by (Responsible Party):
Madhukar H. Trivedi, MD, University of Texas Southwestern Medical Center

Brief Summary:

The Dallas 2K is a 10-year natural history, longitudinal, prospective study of a cohort of 2,000 participants that will help uncover the socio-demographic, lifestyle, clinical, psychological and neurobiological factors that contribute to anti-depressant treatment response: remission, recurrence, relapse and individual outcomes in depressive disorders. Hence, the expected duration of this study is 20 years in length. Since this is an observational study, investigators will explore a comprehensive panel of carefully selected participant specific parameters: socio-demographic (age, ethnicity, economic); lifestyle (physical activity, substance use); clinical (medical history, anxious depression, early life trauma), biological (biomarkers in blood, saliva, urine), behavioral (cognitive, emotional), neurophysiological (EEG), and neuroimaging (structural, functional brain circuitry) with the goal to develop the most robust predictive models of treatment response and of depression outcomes. There is no medication or non-medication treatment or intervention provided by this study.

Subjects will have elevated symptomatology of nonpsychotic chronic or recurrent depressive disorder and will be currently receiving or will be prescribed standard of care medication or non-medication based treatments by their providers/clinicians. The study cohort will reflect the wide range of patients seen in typical primary or psychiatric care settings, and may include unipolar or bipolar disorders and dysthymia (a more chronic form of depression). The cohort will be broadly representative of and generalizable to the US general population as a whole.


Condition or disease Intervention/treatment
Depression Depression, Bipolar Other: Observational Study

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Study Type : Observational
Estimated Enrollment : 2000 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Dallas 2K: A Natural History Study of Depression
Study Start Date : September 2016
Estimated Primary Completion Date : September 2026
Estimated Study Completion Date : September 2026

Resource links provided by the National Library of Medicine


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 2,000 participants. There is no medication or non-medication treatment or intervention provided by this study.




Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. Comparison of Longitudinal changes in functioning as measured by Magnetic Resonance imaging in patients with severe depression [ Time Frame: 10 years ]
  2. Comparison of Longitudinal changes in functioning as measured by quantitative electroencephalography (EEG) in patients with severe depression. [ Time Frame: 10 years ]
  3. Comparison of Longitudinal changes in fluid based biomarkers as measured by proteomic methods in patients with severe depression. [ Time Frame: 10 years ]
  4. Comparison of Longitudinal changes in fluid based biomarkers as measured by metabolomics methods in patients with severe depression. [ Time Frame: 10 years ]
  5. Comparison of Longitudinal changes in fluid based biomarkers as measured by transcriptomic methods in patients with severe depression. [ Time Frame: 10 years ]
  6. Comparison of Longitudinal changes in fluid based biomarkers as measured by genomic methods in patients with severe depression. [ Time Frame: 10 years ]
  7. Comparison of Longitudinal changes in fluid based biomarkers as measured by epigenomic methods in patients with severe depression. [ Time Frame: 10 years ]

Biospecimen Retention:   Samples With DNA
One of the aims of this study is to establish a Dallas 2K biospecimen resource consisting of blood, plasma, serum, PBMCs, DNA, RNA, saliva and urine samples collected from subjects at baseline and at follow-up visits, as a platform for translational research into biochemical and molecular characterization of depression.


Information from the National Library of Medicine

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Ages Eligible for Study:   10 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
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)
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02919280


Contacts
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Contact: Ronnie Pedroncelli, BS 214 648 4357 D2K@UTSouthwestern.edu
Contact: Sangita Sethuram, MBA 214-648-4357 D2K@UTSouthwestern.edu

Locations
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United States, Texas
University of Texas Southwestern Medical Center Recruiting
Dallas, Texas, United States, 75390
Contact: Sangita Sethuram, MBA, CCRP    214-648-4357    D2K@UTSouthwestern.edu   
Principal Investigator: Madhukar Trivedi, MD         
Sponsors and Collaborators
University of Texas Southwestern Medical Center
The Hersh Foundation
Investigators
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Principal Investigator: Madhukar Trivedi, MD University of Texas Southwestern Medical Center
Publications of Results:
Other Publications:
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Responsible Party: Madhukar H. Trivedi, MD, Professor, University of Texas Southwestern Medical Center
ClinicalTrials.gov Identifier: NCT02919280    
Other Study ID Numbers: STU 112015-021
First Posted: September 29, 2016    Key Record Dates
Last Update Posted: May 24, 2021
Last Verified: May 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Additional relevant MeSH terms:
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Depression
Depressive Disorder
Bipolar Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders
Bipolar and Related Disorders