DepressionD2KNCT02919280
Dallas 2K: A Natural History Study of Depression
An observational study of Depression and Depression, Bipolar, run by University of Texas Southwestern Medical Center at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 10 years and olderHealthy volunteers can take part
- Conditions the study is for
- Depression, Depression, Bipolar
- What is being tested?
- Observational Study
- How many people
- 2,500 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Jun 2016to Sep 2036
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
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 for Inclusion of participants:
A potential participant will be eligible for participation in this study if the following criteria are met:
- Male and female adult or youth aged 10 and older of any race or ethnicity.
- 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.
- A lifetime or a current diagnosis of a mood disorder based upon a semi-structured diagnostic interview.
- 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.
- Male and female adult or youth aged 10 and older of any race or ethnicity.
- 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.
- 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:
- History of schizophrenia, schizoaffective disorders or chronic psychotic disorders based upon a semi-structured diagnostic interview.
- Diagnosis of human immunodeficiency virus (HIV) or hepatitis B or C (human immunodeficiency virus (HIV) testing is not required for this study).
- Unable to provide a stable home address and contact information.
- 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.
- 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:
- A lifetime or a current history of a mood disorder based upon a semi-structured diagnostic interview.
- Meets any exclusion criteria as part of the main D2K study interview.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Texas Southwestern Medical Center
Dallas, Texas, 75390
About this study
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.
Read the 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:
- Monthly Surveys: 12 times a year
- MRI: up to 4 times a year
- EEG: up to 4 times a year
- Biospecimen collection: up to 4 times a year
- Cognitive Behavioral Tasks: up to 4 times a year
- Extensive Self-report and Clinician rated assessments: 4 times a year
- Stool Sample collection: up to 4 times a year
- 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.
- Conditions
- Depression, Depression, Bipolar
- Being tested
- Observational Study
- Keywords
- healthy control, depression, bipolar
- Medical subject headings
- Depression, Bipolar Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| No treatment | This is an observational study. No intervention / treatment involved. Receives: Other: Observational Study |
What is being measured
The primary outcome is the main question the study is designed to answer.
Longitudinal changes in depression severity of subjects with elevated symptomatology on Patient Health Questionnaire (PHQ-9) for non-psychotic depressive disorders.
Assessment of changes in depressive symptom severity over time using PHQ- total scores in participants with non-psychotic depressive disorders.
Measured: 10 years
Secondary outcomes (7)
Comparison of Longitudinal changes in functioning as measured by Magnetic Resonance imaging in patients with severe depression
Evaluation of changes in brain structure and function over time using MRI measures in participants with severe depression.
Measured: 10 years
Comparison of Longitudinal changes in functioning as measured by quantitative electroencephalography (EEG) in patients with severe depression.
Evaluation of changes in neurophysiological activity over time using quantitative EEG measures in participants with severe depression.
Measured: 10 years
Comparison of Longitudinal changes in fluid based biomarkers as measured by proteomic methods in patients with severe depression.
Assessment of changes in protein biomarkers profiles over time using proteomic analyses of biological samples.
Measured: 10 years
Comparison of Longitudinal changes in fluid based biomarkers as measured by metabolomics methods in patients with severe depression.
Assessment of changes in metabolite biomarker profiles over time using metabolomic analyses of biological samples.
Measured: 10 years
Comparison of Longitudinal changes in fluid based biomarkers as measured by transcriptomic methods in patients with severe depression.
Assessment of changes in gene expression profiles over time using transcriptomic analyses of biological samples.
Measured: 10 years
Comparison of Longitudinal changes in fluid based biomarkers as measured by genomic methods in patients with severe depression.
Evaluation of genomic markers associated with depression and their relationship to clinical outcomes over time.
Measured: 10 years
Comparison of Longitudinal changes in fluid based biomarkers as measured by epigenomic methods in patients with severe depression.
Assessment of changes in epigenetic markers over time using epigenomic analyses of biological samples.
Measured: 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2016 (estimated)
- Study start14 Jun 2016
- Primary completionSep 2036 (estimated)
- Study completionSep 2036 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for DepressionStudies of the same condition, open and under way.
- More trials run by University of Texas Southwestern Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 2,500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Texas Southwestern Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Madhukar H. Trivedi, MD, University of Texas Southwestern Medical Center
- Investigators
- Madhukar Trivedi, MD, Principal investigator, University of Texas Southwestern Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02919280
- Sponsor's protocol ID
- STU 112015-021
- Acronym
- D2K
- Status last verified
- Sep 2026
- First submitted
- 23 Sep 2016
- Last updated
- 15 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 12813115Rush 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.
PubMed 17074942Trivedi 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.
PubMed 21929768Trivedi 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.
PubMed 16390886Bloom BS. Prevalence and economic effects of depression. Manag Care. 2004 Jun;13(6 Suppl Depression):9-16.
PubMed 15293766Chin 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.
PubMed 41401669
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dallas 2K: A Natural History Study of Depression
- ClinicalTrials.gov ID
- NCT02919280
- Acronym / sponsor ID
- D2K / STU 112015-021
- Conditions
- Depression, Depression, Bipolar
- Keywords
- healthy control, depression, bipolar
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 2,500 participants (estimated)
- Lead sponsor
- University of Texas Southwestern Medical CenterUniversity, hospital or other
- Study start
- 14 Jun 2016 (actual)
- Primary completion
- Sep 2036 (estimated)
- Study completion
- Sep 2036 (estimated)
- First posted
- 29 Sep 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Monthly Surveys: 12 times a year
- MRI: up to 4 times a year
- EEG: up to 4 times a year
- Biospecimen collection: up to 4 times a year
- Cognitive Behavioral Tasks: up to 4 times a year
- Extensive Self-report and Clinician rated assessments: 4 times a year
- Stool Sample collection: up to 4 times a year
- 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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| No treatment | – | Other: Observational StudyThis is an observational study. No intervention / treatment involved. |
Who may qualify
- Ages
- 10 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Observational StudyThe 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. | Other | No treatment |
Primary outcome
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
Assessment of changes in depressive symptom severity over time using PHQ- total scores in participants with non-psychotic depressive disorders.
7 secondary outcomes
Comparison of Longitudinal changes in functioning as measured by Magnetic Resonance imaging in patients with severe depression
Time frame: 10 years
Comparison of Longitudinal changes in functioning as measured by quantitative electroencephalography (EEG) in patients with severe depression.
Time frame: 10 years
Comparison of Longitudinal changes in fluid based biomarkers as measured by proteomic methods in patients with severe depression.
Time frame: 10 years
Comparison of Longitudinal changes in fluid based biomarkers as measured by metabolomics methods in patients with severe depression.
Time frame: 10 years
Comparison of Longitudinal changes in fluid based biomarkers as measured by transcriptomic methods in patients with severe depression.
Time frame: 10 years
Comparison of Longitudinal changes in fluid based biomarkers as measured by genomic methods in patients with severe depression.
Time frame: 10 years
Comparison of Longitudinal changes in fluid based biomarkers as measured by epigenomic methods in patients with severe depression.
Time frame: 10 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2026.
- Background: PubMed 12813115Kessler 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.
- Results publication: PubMed 17074942Rush 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.
- Results publication: PubMed 21929768Trivedi 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.
- Results publication: PubMed 16390886Trivedi 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.
- Results publication: PubMed 15293766Bloom BS. Prevalence and economic effects of depression. Manag Care. 2004 Jun;13(6 Suppl Depression):9-16.
- Derived from this study: PubMed 41401669Chin 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Madhukar Trivedi, MD principal investigator
University of Texas Southwestern Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Depression and Depression, Bipolar, run by University of Texas Southwestern Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 15 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02919280, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Sep 2026.