Computational Assessment of GABA Receptor Modulation in PTSD
NCT06852469 · Status: RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 150
Last updated 2025-07-14
Summary
A substantial majority of Veterans with posttraumatic stress disorder (PTSD) continue to suffer even with the best current medications. Progress in developing more effective medications is hampered by the substantial variability within Veterans with PTSD, meaning the most effective medication likely varies from individual to individual. New scientific tools to help identify distinct subgroups of Veterans with PTSD who are likely to respond to specific medications could help improve treatment in this population. Research has indicated that a specific subgroup of Veterans with PTSD with a high level of anxious arousal may benefit from medications which boost signaling of the neurotransmitter gamma-aminobutyric acid (GABA). This project aims to validate a clinical test to identify these individuals using new computational and neuroimaging methods combined with the medication lorazepam, a positive GABA modulator. The ultimate goal is to use these methods in future clinical trials of new medications to target the best treatments to individual Veterans with PTSD.
Conditions
- Stress Disorders, Post-Traumatic
Interventions
- DRUG
-
Lorazepam 1 mg tablet
Lorazepam is an oral medication which is FDA approved to treat anxiety.
- DRUG
-
Placebo tablet
Placebo will match the study drug in mode of administration, color, size, and taste.
Sponsors & Collaborators
-
VA Office of Research and Development
lead FED
Principal Investigators
-
Jonathan R Howlett, MD · VA San Diego Healthcare System, San Diego, CA
Study Design
- Allocation
- RANDOMIZED
- Purpose
- BASIC_SCIENCE
- Masking
- QUADRUPLE
- Model
- CROSSOVER
Eligibility
- Min Age
- 18 Years
- Max Age
- 65 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2025-07-01
- Primary Completion
- 2029-06-30
- Completion
- 2029-06-30
- FDA Drug
- Yes
Countries
- United States
Study Locations
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