Proof-of-concept Study to Assess the Efficacy and Safety of SRX246 in Adults With PTSD

Study Overview
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Brief Summary
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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.

Official Title
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A Proof of Concept (POC) Clinical Trial for Post-Traumatic Stress Disorder (PTSD) With a First-In-Class Vasopressin 1a Receptor Antagonist (SRX246)

Conditions
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PTSD

Intervention / Treatment
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* Drug: SRX246
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Medically stable, current diagnosis of PTSD Exclusion Criteria: Medically unstable

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SRX246<br>SRX246 160 mg BID, oral administration, capsules, daily for 8 weeks | Drug: SRX246<br>* novel V1a receptor antagonist<br>|
| Placebo Comparator: Placebo<br>oral administration, capsules, daily for 8 weeks | Drug: Placebo<br>* matching placebo<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessment of overall clinical improvement | Measured using the Clinician Administered PTSD Scale (CAPS) | 18 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with treatment-related adverse events | Assessments of adverse events (AEs), dose reductions and dropouts due to AEs | 18 weeks | 
| Reduction in depressive symptoms | Measured using the Beck Depression Inventory (BDI) | 18 weeks | 
| Reduction in anger and aggression | Measured using the Overt Aggression Scale-Modified (OAS-M) | 18 weeks | 
| Reduction in irritability | Measured using the Sheehan Irritability Scale (SIS) | 18 weeks | 
| Improvement in overall functioning | Measured using the Medical Outcomes Study Short-Form 12-Item Health Survey (SF-12) | 18 weeks | 
| Improvement in quality of life | Measured using the Sheehan Disability Scale (SDS) | 18 weeks | 
| Improvement in sleep quality | Measured using the Pittsburgh Sleep Quality Index (PSQI) | 18 weeks |