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Brexpiprazole as an Adjunctive Treatment to Paroxetine or Sertraline in Adult Patients Suffering From Post-traumatic Stress Disorder (PTSD)

NCT01987960 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 417

Last updated 2017-03-13

Study results available
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Summary

To evaluate the efficacy of brexpiprazole as adjunctive treatment to paroxetine (PAR) or sertraline (SER) on PTSD symptoms.

Conditions

  • Post-traumatic Stress Disorder
  • PTSD

Interventions

DRUG

Placebo

Once daily, tablets, orally

DRUG

Brexpiprazole

1 to 3 mg/day, once daily dose, tablets, orally

Sponsors & Collaborators

  • Otsuka Pharmaceutical Co., Ltd.

    collaborator INDUSTRY

  • H. Lundbeck A/S

    lead INDUSTRY

Principal Investigators

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2013-12-31
Primary Completion
2015-10-31
Completion
2015-10-31

Countries

  • United States
  • Estonia
  • Finland
  • France
  • Italy
  • Poland
  • Serbia
  • South Africa
  • Sweden

Study Locations

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Entities

Drugs
Diseases

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 NCT01987960 on ClinicalTrials.gov