UTSW Depression Cohort: A Longitudinal Study of Depression

NCT02697487 | Completed

• 1 other identifier: STU 092015-049
• Study Type: observational
• Target: 447
• Locations: 1 country
• Sites: 1

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.

Conditions

Depression; Other Diagnoses, Comorbidities, and Complications

Keywords

Depression; Cohort

Outcome Measures

Primary Outcomes (1)

• Changes in depression severity as measured by 9-item Patient Health Questionnaire

  Changes in depression severity will be measured by 9-item Patient Health Questionnaire. PHQ-9 score ranges from 0-27, higher score indicates sever depression. Minimal depression 0-4 Mild depression 5-9 Moderate depression 10-14 Moderately severe depression 15-19 Severe depression 20-27

  Change from Baseline to 10 years

Secondary Outcomes (1)

• Changes in functioning as measured by 5-item Work Social Adjustment Scale in participants with and without depression.

  Change from Baseline to 10 years

Study Arms (1)

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

Interventions

No treatment OTHER

This is an observational study with no intervention.

No Treatment

Eligibility Criteria

• Age: 10 Years - 89 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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).

You may not qualify if:

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

Sponsors & Collaborators

• University of Texas Southwestern Medical Center: lead

Study Sites (1)

University of Texas Southwestern Medical Center

Dallas, Texas, 75390, United States

Location

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.

MeSH Terms

Conditions

Depression

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Study Officials

• Madhukar Trivedi, MD

  University of Texas Southwestern Medical Center

  PRINCIPAL INVESTIGATOR

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: February 23, 2016
• First Posted: March 3, 2016
• Study Start: February 1, 2016
• Primary Completion: March 22, 2018
• Study Completion: March 22, 2018
• Last Updated: November 7, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will share

Locations

US (1)