Computational Assessment of GABA Receptor Modulation in PTSD
ConditionStress Disorders, Post-Traumatic
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18-65
SponsorVA Office of Research and Development
About this trial
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.
Eligibility criteria
Qualifiers
Veteran;
18-65 years of age, inclusive;
Participants must be willing to abstain from alcohol 24 hours prior to and 24 hours after the testing session;
Participants must be able to participate and willing to give written informed consent and to comply with the study restrictions;
Disqualifiers
Has uncontrolled, clinically significant neurologic (including seizure disorders), cardiovascular, pulmonary, hepatic, renal, metabolic, gastrointestinal, urologic, immunologic, endocrine disease, or psychiatric disorder, or other abnormality, which may impact the ability of the subject to participate or potentially confound the study results;
Pregnancy (assessed by urine test at time of screening and prior to administration of study medication) or lactation;
Lifetime history of a chronic psychotic disorder or bipolar disorder type I as assessed by MINI;
Current moderate or severe substance use disorder as assessed by MINI;
Trial design
Treatments tested in this trial
- Lorazepam 1 mg tablet
- Placebo tablet
Treatment groups
150 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov