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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)

NCT03033069 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 336

Last updated 2021-12-08

Study results available
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Summary

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

Conditions

  • Stress Disorders, Post-Traumatic

Interventions

DRUG

Brexpiprazole

Brexpiprazole oral tablets.

DRUG

Sertraline

Sertraline oral capsules.

DRUG

Brexpiprazole Matching Placebo

Brexpiprazole matching placebo oral tablets.

DRUG

Sertraline Matching Placebo

Sertraline matching placebo oral capsules.

Sponsors & Collaborators

  • H. Lundbeck A/S

    collaborator INDUSTRY

  • Otsuka Pharmaceutical Development & Commercialization, Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-01-26
Primary Completion
2018-11-12
Completion
2018-11-12
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03033069 on ClinicalTrials.gov