The purpose of this study is to test the drug PT150, which blocks glucocorticoid receptor (GR) signaling, for treatment of PTSD in Veterans, and establish a safety and efficacy profile that will inform the design of future studies.
This is a dual-site, proof-of-concept, parallel arm, double-blind placebo control study of a 14-day single daily dose of PT150/placebo in 100 Veterans with PTSD. Each site will enroll 60 Veterans with PTSD to ensure 100 study completers. Preclinical studies of PT150 and similar types of glucocorticoid antagonists have shown that they block stress responses in both acute and chronic models of stress response. PT150 has been tested previously in healthy control populations and in populations with depression, with it being found to be well tolerated and safe. Drug interaction results suggest it does not interact with alcohol or serotonin reuptake inhibitors, again supporting its safety and making it a candidate for further development. The goal of this Phase2a study is to tests its efficacy to reduce PTSD symptoms, as well as other biomarkers associated with PTSD. Participants first will undergo screening procedures, including a medical exam, clinical interview, self-report questionnaires, and blood draw. If eligible, they will be randomized to either PT150 or placebo. The PT150 dose will be titrated from 150-600mg over days 1-7, with the max dose of 900mg/day given the remaining 7 day timeframe. The same procedures will be repeated before, during and after taking the study drug or placebo for fourteen days. The key outcome measures will be obtained at baseline, day 28, and day 84.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
120
Jennifer Moreno Department of VA Medical Center
San Diego, California, United States
Michael E DeBakey VA Medical Center
Houston, Texas, United States
PTSD Symptoms - Clinician Administered PTSD Scale for DSM-5 (CAPS)
The CAPS is the gold standard assessment of PTSD, providing a dimensional and categorical measure of PTSD, and incorporates frequency and intensity of symptoms into a single severity score. This manualized clinician-assessed interview contains 30 items.
Time frame: approximately 4 weeks
Side Effects - Frequency, Intensity, Burden of Side Effects (FIBSER)
The FIBSER is a self-report 0-6 Likert-type scale that measures global frequency, intensity, and overall burden of side effects.
Time frame: 1, 2, 4, 12 weeks post treatment initiation
Alcohol Drinking - The Time Line Follow Back (TLFB)
The Time Line Follow Back (TLFB) is designed for collecting self-reported, retrospective estimates of AOD use and is extensively used to assess daily AOD use in research and practice
Time frame: 1, 2, 4 and 12 weeks after treatment initiation
PTSD Symptoms - follow up
Clinician Administered PTSD Scale for DSM-5 (CAPS) will be administered at 12 weeks post treatment initiation to estimate longevity of effects of PT150 on PTSD symptoms.
Time frame: 12 weeks post treatment initiation
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