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Brexpiprazole as Adjunctive Treatment in Patients With Major Depressive Disorder With an Inadequate Response to Antidepressant Treatment

NCT01838681 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1986

Last updated 2017-08-09

Study results available
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Summary

To evaluate the long-term efficacy and safety of brexpiprazole as an adjunctive treatment to an antidepressant treatment (ADT) for adult patients with Major Depressive Disorder (MDD).

Conditions

Interventions

DRUG

Placebo

Once daily, tablets, orally

DRUG

Brexpiprazole

1, 2, or 3 mg/day, once daily dose, tablets, orally. Uptitration in weekly steps from 1 mg/day

DRUG

ADT

Duloxetine, escitalopram, fluoxetine, paroxetine IR, sertraline, venlafaxine XR; dosing according to label

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
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-06-30
Primary Completion
2016-06-30
Completion
2016-06-30

Countries

  • United States
  • Bulgaria
  • Canada
  • Estonia
  • Finland
  • Germany
  • Latvia
  • Lithuania
  • Mexico
  • Poland
  • Romania
  • Russia
  • South Korea
  • Sweden
  • Ukraine
  • United Kingdom

Study Locations

More Related Trials

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 NCT01838681 on ClinicalTrials.gov