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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

591 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-10-30

Study Completion Date

2023-08-15

Brief Summary

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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.

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Detailed Description

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Conditions

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Post Traumatic Stress Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Placebo

All enrolled participants received brexpiprazole-matched placebo tablets and sertraline-matched placebo tablets during the 1-week placebo run-in period.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

Pill

Brexpiprazole (2 mg) + Sertraline

Randomized participants received brexpiprazole 2 milligrams (mg), orally, once daily (QD) in combination with sertraline, 150 mg, orally, QD from Week 1 to Week 12 of the double-blind treatment (DBT) period.

Group Type EXPERIMENTAL

Sertraline

Intervention Type DRUG

150 mg pill

Brexpiprazole

Intervention Type DRUG

2 mg pill

Brexpiprazole (3 mg) + Sertraline

Randomized participants received brexpiprazole 3 mg, orally, QD in combination with sertraline, 150 mg, orally, QD from Week 1 to Week 12 of the DBT period.

Group Type EXPERIMENTAL

Brexpiprazole

Intervention Type DRUG

3 mg pill

Sertraline

Intervention Type DRUG

150 mg pill

Sertraline + Placebo

Randomized participants received sertraline 150 mg, orally, QD, in combination with sertraline matching placebo, orally, QD from Week 1 to Week 12 of the DBT period.

Group Type EXPERIMENTAL

Sertraline

Intervention Type DRUG

150 mg pill

Placebo

Intervention Type OTHER

Pill

Interventions

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Brexpiprazole

3 mg pill

Intervention Type DRUG

Sertraline

150 mg pill

Intervention Type DRUG

Placebo

Pill

Intervention Type OTHER

Brexpiprazole

2 mg pill

Intervention Type DRUG

Other Intervention Names

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Rexulti Zoloft Rexulti

Eligibility Criteria

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Inclusion Criteria

* Male and female outpatients 18 to 65 years of age, inclusive, at the time of informed consent.
* Participants who have post-traumatic stress disorder (PTSD), diagnosed according to Diagnostic and Statistical Manual of Mental Disorders, 5th edition (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.
* Participants who have experienced a traumatic event within 3 months of screening.
* Participants 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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No