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UTSW Depression Cohort: A Longitudinal Study of Depression

NCT02697487 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 447

Last updated 2023-11-07

No results posted yet for this study

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.

Conditions

  • Depression
  • Other Diagnoses, Comorbidities, and Complications

Interventions

OTHER

No treatment

This is an observational study with no intervention.

Sponsors & Collaborators

  • University of Texas Southwestern Medical Center

    lead OTHER

Principal Investigators

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

Eligibility

Min Age
10 Years
Max Age
89 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2016-02-29
Primary Completion
2018-03-22
Completion
2018-03-22

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 NCT02697487 on ClinicalTrials.gov