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A Study of Flexible Dose Brexpiprazole as Monotherapy or Combination Therapy in the Treatment of Adults With Post-traumatic Stress Disorder (PTSD)

NCT ID: NCT03033069

Last Updated: 2021-12-08

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

336 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-01-26

Study Completion Date

2018-11-12

Brief Summary

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To evaluate the safety, efficacy and tolerability of brexpiprazole (with placebo) as monotherapy or combination therapy with Zoloft (sertraline) in adults with PTSD.

Detailed Description

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This trial is designed to assess the efficacy, safety and tolerability of flexible dose brexpiprazole as monotherapy or as combination therapy with Zoloft (Sertraline) in adult participants with PTSD.

This study will consist of a continuous 12-week, double-blind treatment period with a 14-day follow-up.

Conditions

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Stress Disorders, Post-Traumatic

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Brexpiprazole + Sertraline

Participants were administered oral brexpiprazole initial dose of 0.5 milligram (mg)/day plus sertraline initial dose of 50 mg/day. The dose was up titrated to brexpiprazole maximum dose of 3 mg/day and sertraline maximum dose of 200 mg/day and continued thereafter up to Week 12 based on efficacy and tolerability. No dose reductions were allowed after Week 6 and no dose increments were allowed after Week 4. Participants also received sertraline matching placebo based on dose titration/adjustment up to Week 12.

Group Type EXPERIMENTAL

Brexpiprazole

Intervention Type DRUG

Brexpiprazole oral tablets.

Sertraline

Intervention Type DRUG

Sertraline oral capsules.

Sertraline Matching Placebo

Intervention Type DRUG

Sertraline matching placebo oral capsules.

Brexpiprazole

Participants were administered oral brexpiprazole initial dose of 0.5 mg/day The dose was up titrated to brexpiprazole maximum dose of 3 mg/day and continued thereafter up to Week 12 based on efficacy and tolerability. No dose reductions were allowed after Week 6 and no dose increments were allowed after Week 4. Participants also received sertraline matching placebo up to Week 12.

Group Type EXPERIMENTAL

Brexpiprazole

Intervention Type DRUG

Brexpiprazole oral tablets.

Sertraline Matching Placebo

Intervention Type DRUG

Sertraline matching placebo oral capsules.

Sertraline

Participants were administered oral sertraline initial dose of 50 mg/day. The dose was up titrated to sertraline maximum dose of 200 mg/day and continued thereafter up to Week 12 based on efficacy and tolerability. No dose reductions were allowed after Week 6 and no dose increments were allowed after Week 4. Participants also received brexpiprazole matching placebo and sertraline matching placebo based on dose titration/adjustment up to Week 12.

Group Type ACTIVE_COMPARATOR

Sertraline

Intervention Type DRUG

Sertraline oral capsules.

Brexpiprazole Matching Placebo

Intervention Type DRUG

Brexpiprazole matching placebo oral tablets.

Sertraline Matching Placebo

Intervention Type DRUG

Sertraline matching placebo oral capsules.

Placebo

Participants received oral brexpiprazole matching placebo tablet and oral sertraline matching placebo capsules up to Week 12.

Group Type PLACEBO_COMPARATOR

Brexpiprazole Matching Placebo

Intervention Type DRUG

Brexpiprazole matching placebo oral tablets.

Sertraline Matching Placebo

Intervention Type DRUG

Sertraline matching placebo oral capsules.

Interventions

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Brexpiprazole

Brexpiprazole oral tablets.

Intervention Type DRUG

Sertraline

Sertraline oral capsules.

Intervention Type DRUG

Brexpiprazole Matching Placebo

Brexpiprazole matching placebo oral tablets.

Intervention Type DRUG

Sertraline Matching Placebo

Sertraline matching placebo oral capsules.

Intervention Type DRUG

Other Intervention Names

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OPC-34712 OPC-331 Zoloft

Eligibility Criteria

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Inclusion Criteria

* Male and female participants between the years of 18-65 with a diagnosis of PTSD (diagnosis can be made at screening)

Exclusion Criteria

* Index trauma event \>15 years before screening
* Index trauma event at age \<16
* Any traumatic event within 3 months of screening
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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H. Lundbeck A/S

INDUSTRY

Sponsor Role collaborator

Otsuka Pharmaceutical Development & Commercialization, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Investigational Site

Tuscaloosa, Alabama, United States

Site Status

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Phoenix, Arizona, United States

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Little Rock, Arkansas, United States

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Rogers, Arkansas, United States

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Bellflower, California, United States

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Beverly Hills, California, United States

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Glendale, California, United States

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National City, California, United States

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Oceanside, California, United States

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Oceanside, California, United States

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Orange, California, United States

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Redlands, California, United States

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Riverside, California, United States

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San Diego, California, United States

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San Marcos, California, United States

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Torrance, California, United States

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Colorado Springs, Colorado, United States

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Bradenton, Florida, United States

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Fort Lauderdale, Florida, United States

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Fort Myers, Florida, United States

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Gainesville, Florida, United States

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Jacksonville, Florida, United States

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North Miami, Florida, United States

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Orlando, Florida, United States

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Orlando, Florida, United States

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Tampa, Florida, United States

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Atlanta, Georgia, United States

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Decatur, Georgia, United States

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Roswell, Georgia, United States

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Chicago, Illinois, United States

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St Louis, Missouri, United States

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Las Vegas, Nevada, United States

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Berlin, New Jersey, United States

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Princeton, New Jersey, United States

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Brooklyn, New York, United States

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Cedarhurst, New York, United States

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New York, New York, United States

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Rochester, New York, United States

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Charlotte, North Carolina, United States

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Raleigh, North Carolina, United States

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Cincinnati, Ohio, United States

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Oklahoma City, Oklahoma, United States

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Oklahoma City, Oklahoma, United States

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Portland, Oregon, United States

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Salem, Oregon, United States

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Media, Pennsylvania, United States

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Norristown, Pennsylvania, United States

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Lincoln, Rhode Island, United States

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Charleston, South Carolina, United States

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Memphis, Tennessee, United States

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Bellaire, Texas, United States

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San Antonio, Texas, United States

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Wichita Falls, Texas, United States

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Everett, Washington, United States

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Countries

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United States

References

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Hobart M, Chang D, Hefting N, Davis LL. Brexpiprazole in Combination With Sertraline and as Monotherapy in Posttraumatic Stress Disorder: A Full-Factorial Randomized Clinical Trial. J Clin Psychiatry. 2025 Feb 19;86(1):24m15577. doi: 10.4088/JCP.24m15577.

Reference Type DERIVED
PMID: 40009045 (View on PubMed)

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

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331-201-00061

Identifier Type: -

Identifier Source: org_study_id