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

Otsuka

Status and phase: Completed; Phase 2

Conditions: Stress Disorders, Post-Traumatic

Treatments: Drug: Sertraline; Drug: Sertraline Matching Placebo; Drug: Brexpiprazole; Drug: Brexpiprazole Matching Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT03033069

331-201-00061

Details and patient eligibility

About

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

Full description

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.

Enrollment: 336 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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336 participants in 4 patient groups, including a placebo group

Brexpiprazole + Sertraline

Experimental group

Description:

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.

Treatment:

Drug: Sertraline Matching Placebo

Drug: Brexpiprazole

Drug: Sertraline

Brexpiprazole

Experimental group

Description:

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.

Treatment:

Drug: Sertraline Matching Placebo

Drug: Brexpiprazole

Sertraline

Active Comparator group

Description:

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.

Treatment:

Drug: Brexpiprazole Matching Placebo

Drug: Sertraline Matching Placebo

Drug: Sertraline

Placebo

Placebo Comparator group

Description:

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

Treatment:

Drug: Brexpiprazole Matching Placebo

Drug: Sertraline Matching Placebo