Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

UTSW Depression Cohort: A Longitudinal Study of Depression

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02697487
Recruitment Status : Active, not recruiting
First Posted : March 3, 2016
Last Update Posted : October 2, 2019
Sponsor:
Information provided by (Responsible Party):
Madhukar H. Trivedi, MD, University of Texas Southwestern Medical Center

Brief Summary:
This is a longitudinal observational study (via electronic records and biospecimens) designed to utilize health IT advances to collect information from patients undergoing routine care. This information will be stored in a database. Patients undergoing routine care from their providers will be invited to participate in the UTSW Depression Cohort. After obtaining informed consent, the CDRCC team will collect information from available sources and store it in a secure UT Southwestern network database protected by a security firewall. A schematic representation of this information processing is shown in the figure contained in section 3 of the protocol. As part of the UTSW Depression Cohort, patients will allow banking of their specimens. Specimens which are banked may include blood or blood products, urine, tissue samples, saliva, stool samples or clinical waste products. The study will only enroll participants comfortable with providing specimens. As the goal of the UTSW Depression Cohort is to create a national database, CDRCC will engage with patients, providers, and researchers at local, regional, and national levels. A large number of medical providers are already screening patients for depression. Structured instruments like PHQ-2 or PHQ-9 are often used. Hence, the CDRCC will seek collaborations with local, regional and national partners so that information contained in their health IT initiatives can be included in the this database. Due to the clinical nature of information collected, the investigators anticipate marked heterogeneity in the variables and amount of data collected. Database architects will utilize big data (large volumes of information from diverse sources with variable degrees of quality and complexity) tools to structure the registry so that additional variables can be added, as needed. The CDRCC team will maintain a detailed codebook of variables collected in the database. All statistical analyses will be conducted only on de-identified data. Researchers may obtain access to this de-identified data by following procedures established by the CDRCC, which include obtaining IRB approval.

Condition or disease Intervention/treatment
Depression Other Diagnoses, Comorbidities, and Complications Other: No treatment

  Show Detailed Description

Layout table for study information
Study Type : Observational
Estimated Enrollment : 100000 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: UTSW Depression Cohort: A Longitudinal Study of Depression
Study Start Date : February 2016
Estimated Primary Completion Date : February 2026
Estimated Study Completion Date : February 2027

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
No Treatment
This is a longitudinal observational study involving individuals who are depressed, depressed with other comorbidities and non-depressed individuals. The primary aim of this study is to describe the longitudinal course of illness and real world treatment outcomes for depressed patients receiving routine care from their providers. Health outcomes and biospecimens along with the functional and economic burden of depression will be characterized and compared amongst three groups: (1) depressed patients, (2) depressed patients with comorbid illnesses, and (3) non-depressed patients.
Other: No treatment
This is an observational study with no intervention.




Primary Outcome Measures :
  1. Longitudinal changes in depression severity as measured by 9-item Patient Health Questionnaire [ Time Frame: 10 years ]

Secondary Outcome Measures :
  1. Comparison of longitudinal changes in functioning as measured by 5-item Work and Social Adjustment Scale in participants with and without depression. [ Time Frame: 10 years ]

Biospecimen Retention:   Samples With DNA

Biospecimens being studied is as follows:

  1. Blood
  2. Normal Tissue
  3. Saliva
  4. Urine
  5. Stool
  6. Clinical waste products to include surgical waste tissue samples, placenta samples, and biopsy samples.


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   10 Years to 89 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

The following groups are being targeted for this observational study:

  1. depressed patients,
  2. depressed patients with comorbid illnesses, and
  3. non-depressed patients.
Criteria

Inclusion Criteria:

  • Participants ages 10 - 89 years who speak English or Spanish (consent and HIPAA authorization forms will be translated in Spanish for mono-lingual Spanish-speaking only participants).
  • Provide informed consent (parent or LAR for participants aged 10 to 17).

Exclusion Criteria:

  • Participants who do not speak English or Spanish.
  • Participants who are less than 10 or greater than 89 years old.

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): NCT02697487


Locations
Layout table for location information
United States, Texas
University of Texas Southwestern Medical Center
Dallas, Texas, United States, 75390
Sponsors and Collaborators
University of Texas Southwestern Medical Center
Investigators
Layout table for investigator information
Principal Investigator: Madhukar Trivedi, MD University of Texas Southwestern Medical Center

Additional Information:
Layout table for additonal information
Responsible Party: Madhukar H. Trivedi, MD, Professor, University of Texas Southwestern Medical Center
ClinicalTrials.gov Identifier: NCT02697487     History of Changes
Other Study ID Numbers: STU 092015-049
First Posted: March 3, 2016    Key Record Dates
Last Update Posted: October 2, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Keywords provided by Madhukar H. Trivedi, MD, University of Texas Southwestern Medical Center:
Depression
Cohort
Additional relevant MeSH terms:
Layout table for MeSH terms
Depression
Depressive Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders