Brexpiprazole as Combination Therapy With Sertraline in Treatment of Adults With PTSD

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

This will be a 12-week, multicenter, randomized, double-blind trial evaluating the efficacy, safety, and tolerability of brexpiprazole + sertraline combination treatment in adult subjects with Post-Traumatic Stress Disorder.

Study Overview

• Status: Completed
• Conditions: Post Traumatic Stress Disorder
• Intervention / Treatment: Drug: Brexpiprazole; Drug: Sertraline; Other: Placebo

• Study Type: Interventional
• Enrollment (Actual): 450
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • California
    • San Diego, California, United States, 92103
      • For additional information regarding sites, contact 844-687-8522

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 develop 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Placebo; 3 pills: Brexpiprazole-matched placebo tablets and Sertraline-matched placebo tablets may be administered. Doses to be taken simultaneously. Assignment to these options may change during the treatment period.	Other: Placebo; Pill
Experimental: Brexpiprazole + Sertraline; 3 pills: Dose of up to 3 mg /day may be administered of brexpiprazole, dose up to 150 mg/day may be administered of sertraline, placebo or a combination of these. Doses to be taken simultaneously. Assignment to these options may change during the treatment period.	Drug: Brexpiprazole; Up to 3 mg pill; Other Names: Rexulti; Drug: Sertraline; Up to 150 mg pill; Other Names: Zoloft
Experimental: Sertraline; 3 pills: Dose up to 150 mg/ day may be administered of sertraline, placebo or a combination of these. Doses to be taken simultaneously. Assignment to these options may change during the treatment period.	Drug: Sertraline; Up to 150 mg pill; Other Names: Zoloft; Other: Placebo; Pill

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) total score	CAPS-5 is a structured interview designed to assess PTSD diagnostic statusand symptoms 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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Change in Brief Inventory or 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

Collaborators and Investigators

• Sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): October 17, 2019
• Primary Completion (Actual): July 19, 2023
• Study Completion (Actual): August 8, 2023

Study Registration Dates

• First Submitted: October 10, 2019
• First Submitted That Met QC Criteria: October 10, 2019
• First Posted (Actual): October 11, 2019

Study Record Updates

• Last Update Posted (Actual): September 1, 2023
• Last Update Submitted That Met QC Criteria: August 31, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Keywords: PTSD
• Additional Relevant MeSH Terms: Mental Disorders; Trauma and Stressor Related Disorders; Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Psychotropic Drugs; Neurotransmitter Uptake Inhibitors; Membrane Transport Modulators; Serotonin Agents; Antidepressive Agents; Dopamine Agonists; Dopamine Agents; Selective Serotonin Reuptake Inhibitors; Sertraline; Brexpiprazole
• Other Study ID Numbers: 331-201-00071

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Anonymized Individual participant data (IPD) that underlie the results of this study will be shared with researchers to achieve aims pre-specified in a methodologically sound research proposal. Small studies with less than 25 participants are excluded from data sharing.
• IPD Sharing Time Frame: Data will be available after marketing approval in global markets, or beginning 1-3 years following article publication. There is no end date to the availability of the data.
• IPD Sharing Access Criteria: Otsuka will share data on an Otsuka-owned remotely accessible data sharing platform with Python and R analytical software. Research requests should be directed to clinicaltransparency@Otsuka-us.com
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No