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

Otsuka

Status and phase: Completed; Phase 3

Conditions: Post Traumatic Stress Disorder

Treatments: Drug: Sertraline; Other: Placebo; Drug: Brexpiprazole

Study type: Interventional

Funder types: Industry

Identifiers

NCT04174170

331-201-00072

Details and patient eligibility

About

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.

Enrollment: 591 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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591 participants in 4 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

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

Treatment:

Other: Placebo

Brexpiprazole (2 mg) + Sertraline

Experimental group

Description:

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.

Treatment:

Drug: Brexpiprazole

Drug: Brexpiprazole

Drug: Sertraline

Brexpiprazole (3 mg) + Sertraline

Experimental group

Description:

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.

Treatment:

Drug: Brexpiprazole

Drug: Brexpiprazole

Drug: Sertraline

Sertraline + Placebo

Experimental group

Description:

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.

Treatment:

Other: Placebo

Drug: Sertraline