NCT02733614

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
33

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Dec 2016

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 29, 2016

Completed
13 days until next milestone

First Posted

Study publicly available on registry

April 11, 2016

Completed
8 months until next milestone

Study Start

First participant enrolled

December 1, 2016

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2020

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2021

Completed
Last Updated

November 1, 2021

Status Verified

October 1, 2021

Enrollment Period

3.8 years

First QC Date

March 29, 2016

Last Update Submit

October 25, 2021

Conditions

PTSD

Outcome Measures

Primary Outcomes (1)

  • Assessment of overall clinical improvement

    Measured using the Clinician Administered PTSD Scale (CAPS)

    18 weeks

Secondary Outcomes (7)

  • Number of participants with treatment-related adverse events

    18 weeks

  • Reduction in depressive symptoms

    18 weeks

  • Reduction in anger and aggression

    18 weeks

  • Reduction in irritability

    18 weeks

  • Improvement in overall functioning

    18 weeks

  • +2 more secondary outcomes

Study Arms (2)

SRX246

EXPERIMENTAL

SRX246 160 mg BID, oral administration, capsules, daily for 8 weeks

Drug: SRX246

Placebo

PLACEBO COMPARATOR

oral administration, capsules, daily for 8 weeks

Drug: Placebo

Interventions

SRX246DRUG

novel V1a receptor antagonist

SRX246
PlaceboDRUG

matching placebo

Placebo

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Medically stable, current diagnosis of PTSD

You may not qualify if:

  • Medically unstable

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Weill Cornell Medical College

New York, New York, 10065, United States

Location

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic

Interventions

SRX246

Condition Hierarchy (Ancestors)

Stress Disorders, TraumaticTrauma and Stressor Related DisordersMental Disorders

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 29, 2016

First Posted

April 11, 2016

Study Start

December 1, 2016

Primary Completion

October 1, 2020

Study Completion

March 31, 2021

Last Updated

November 1, 2021

Record last verified: 2021-10

Data Sharing

IPD Sharing
Will not share

Locations

US(1)