Genomics of Posttraumatic Stress Disorder in Veterans

NCT02256644 | Completed

• 1 other identifier: 575B
• Study Type: observational
• Target: 20,000
• Locations: 1 country
• Sites: 1

Brief Summary

Posttraumatic Stress Disorder (PTSD), as a common and serious mental health condition, affects about 25% of all military personnel that have served in combat. People suffering from PTSD may experience traumatic flashbacks, trouble sleeping, and problems in their relationships. This study is intended to help identify genes that influence and increase the risk of PTSD, to improve ways of detecting and treating the condition in the future. Previous research has studied genes that increase the risk of PTSD, but none of these have included a Veteran-only population. The current study focuses on US Veterans, utilizing the VA Million Veteran Program (MVP) database of approximately 300,000 participants as of August 2014. In this context, participants with PTSD are referred to as "cases" and Veterans without PTSD are referred to as "controls." This project will be done in three stages. The first stage will look at MVP-obtained data and electronic health record (EHR) data to implement methods for identifying combat-exposed case patients with PTSD and combat-exposed control patients without PTSD. The second stage will assemble and validate a study population of 20,000 participants "including 10,000 combat-exposed Veterans with PTSD as cases and 10,000 combat-exposed Veterans without PTSD as controls. The third stage will conduct genetic analyses ("genotyping") comparing the cases to controls, to identify genes associated with increased risk of developing the condition.

Conditions

PTSD

Outcome Measures

Primary Outcomes (1)

• PTSD diagnosis

  The study will use a case-control design nested within the VA Million Veteran Program (MVP), with genotype as the exposure variable and PTSD diagnosis (yes/no) as the outcome variable.

  2 years

Study Arms (1)

Million Veteran Program (MVP) participants

Veterans who are currently enrolled in the Million Veteran Program.

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

The investigators expect 70-80% European-American (EA) and 20-30% African American (AA) in the current study

You may qualify if:

• Combat-exposed Veterans who participated in the Million Veteran Program.

You may not qualify if:

• schizophrenia
• bipolar disorder

Sponsors & Collaborators

• VA Office of Research and Development: lead

Study Sites (1)

VA San Diego Healthcare System, San Diego, CA

San Diego, California, 92161-0002, United States

Location

Related Publications (2)

• Austin-Zimmerman I, Levey DF, Giannakopoulou O, Deak JD, Galimberti M, Adhikari K, Zhou H, Denaxas S, Irizar H, Kuchenbaecker K, McQuillin A; Million Veteran Program; Concato J, Buysse DJ, Gaziano JM, Gottlieb DJ, Polimanti R, Stein MB, Bramon E, Gelernter J. Genome-wide association studies and cross-population meta-analyses investigating short and long sleep duration. Nat Commun. 2023 Sep 28;14(1):6059. doi: 10.1038/s41467-023-41249-y.

  PMID: 37770476 DERIVED

• Radhakrishnan K, Aslan M, Harrington KM, Pietrzak RH, Huang G, Muralidhar S, Cho K, Quaden R, Gagnon D, Pyarajan S, Sun N, Zhao H, Gaziano M, Concato J, Stein MB, Gelernter J. Genomics of posttraumatic stress disorder in veterans: Methods and rationale for Veterans Affairs Cooperative Study #575B. Int J Methods Psychiatr Res. 2019 Mar;28(1):e1767. doi: 10.1002/mpr.1767. Epub 2019 Feb 14.

  PMID: 30767326 DERIVED

Related Links

• Related Info

Biospecimen

Retention: SAMPLES WITH DNA

Affymetrix Axiom Biobank chip, with technical specifications including "295K tag SNPs", "260K exomic content", "65K loss-of-function SNPs \& INDELs", "25K psych content", and "23K eQTL markers".

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders

Study Officials

• Murray B Stein, MD MPH

  VA San Diego Healthcare System, San Diego, CA

  STUDY CHAIR

• Joel Gelernter, MD

  VA Connecticut Healthcare System West Haven Campus, West Haven, CT

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: OTHER
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 1, 2014
• First Posted: October 3, 2014
• Study Start: December 1, 2013
• Primary Completion: August 1, 2014
• Study Completion: September 30, 2024
• Last Updated: October 3, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)