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

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

Status

Terminated

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02733614

Enrollment

Registered

2016-04-11

Start date

2016-12-31

Completion date

2021-03-31

Last updated

2021-11-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

PTSD

Brief summary

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.

Interventions

DRUGSRX246

novel V1a receptor antagonist

DRUGPlacebo

matching placebo

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

Inclusion criteria

* Medically stable, current diagnosis of PTSD

Exclusion criteria

* Medically unstable

Design outcomes

Primary

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

Secondary

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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026