Brexpiprazole as Combination Therapy With Sertraline in the Treatment of Adults With Post-traumatic Stress Disorder

Post Traumatic Stress Disorder Clinical Trial

Official title:

A Phase 3, Multicenter, Randomized, Double-blind Trial of Fixed-Dose Brexpiprazole as Combination Therapy With Sertraline in the Treatment of Adults With Post-traumatic Stress Disorder

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04174170
• Other study ID #: 331-201-00072
• Status: Completed
• Phase: Phase 3
• Start date: October 30, 2019
• Est. completion date: August 15, 2023

Study information

• Verified date: August 2023
• Source: Otsuka Pharmaceutical Development & Commercialization, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This will be a 12-week, multicenter, randomized, double-blind trial evaluating the efficacy, safety, and tolerability of fixed-dose brexpiprazole + sertraline combination treatment in adult subjects with post-traumatic stress disorder.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 591
• Est. completion date: August 15, 2023
• Est. primary completion date: July 25, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Male and female outpatients 18 to 65 years of age, inclusive, at the time of informed consent.
• Subjects who have PTSD, diagnosed according to DSM-5, and confirmed by the Mini International Neuropsychiatric Interview (MINI).
• Onset of symptoms meeting the DSM-5 criteria for PTSD symptoms for a minimum of 6 months prior to screening.

Exclusion Criteria:

• The index traumatic event that led to the development of PTSD took place > 9 years before screening.
• The index traumatic event occurred before age 16.
• Subjects who have experienced a traumatic event within 3 months of screening.
• Subjects who are receiving disability payments because of PTSD or any other psychiatric disorder; unless the disability payments will not be impacted by potential improvements demonstrated in the trial.

Related Conditions & MeSH terms

• Post Traumatic Stress Disorder
• Stress Disorders, Post-Traumatic
• Stress Disorders, Traumatic

Intervention

Drug:
• Brexpiprazole
Up to 3 mg pill
• Sertraline
Up to 150 mg pill

Other:
• Placebo
Pill

Locations

Country	Name	City	State
United States	For additional information regarding sites, contact 844-687-8522	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Otsuka Pharmaceutical Development & Commercialization, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) total score	CAPS-5 is a structured interview designed to assess PTSD diagnostic status and symptom severity as defined by the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5). The interview consists of 30 items, with a higher score indicating a worse outcome.	Up to 12 weeks
Secondary	Change in Clinical Global Impression - Severity (CGI-S) score	An observer-rated scale with a total score range of 0 to 7. A higher score represents a worse outcome. Change from baseline to assess efficacy	Up to 12 weeks
Secondary	Change in Brief Inventory of Psychosocial Functions (B-IPF) score	Patient-reported questionnaire consisting of 7 questions, each scored from 0 to 6, which measure PTSD-specific psychosocial function, with a higher score representing a worse outcome.	Up to 12 weeks