18-week, crossover, double-blind, randomized, placebo controlled proof-of-concept study to assess the efficacy and safety of SRX246 (160 mg bid) vs placebo in 52 adult veterans and civilians with a primary diagnosis of PTSD. Subjects will be randomly assigned in a double-blind fashion to 2 groups in a crossover design. The first group will receive SRX246 for 8 weeks followed by 8 weeks of placebo, while the second group will receive placebo for 8 weeks followed by 8 weeks of SRX246. Both groups will engage in a 7-day washout period between treatments. Subjects will be assessed at baseline and then every 2 weeks during the trial using the CAPS.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
33
novel V1a receptor antagonist
matching placebo
Weill Cornell Medical College
New York, New York, United States
Assessment of overall clinical improvement
Measured using the Clinician Administered PTSD Scale (CAPS)
Time frame: 18 weeks
Number of participants with treatment-related adverse events
Assessments of adverse events (AEs), dose reductions and dropouts due to AEs
Time frame: 18 weeks
Reduction in depressive symptoms
Measured using the Beck Depression Inventory (BDI)
Time frame: 18 weeks
Reduction in anger and aggression
Measured using the Overt Aggression Scale-Modified (OAS-M)
Time frame: 18 weeks
Reduction in irritability
Measured using the Sheehan Irritability Scale (SIS)
Time frame: 18 weeks
Improvement in overall functioning
Measured using the Medical Outcomes Study Short-Form 12-Item Health Survey (SF-12)
Time frame: 18 weeks
Improvement in quality of life
Measured using the Sheehan Disability Scale (SDS)
Time frame: 18 weeks
Improvement in sleep quality
Measured using the Pittsburgh Sleep Quality Index (PSQI)
Time frame: 18 weeks
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