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Study of Aripiprazole as an Adjunctive Therapy in Patients With Major Depressive Disorder

NCT00876343 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 586

Last updated 2014-02-10

Study results available
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Summary

To examine the efficacy and safety of aripiprazole versus placebo as an adjunctive therapy co-administered with either an selective serotonin reuptake inhibitor (SSRI) or a serotonin-norepinephrine reuptake inhibitor (SNRI) in patients with major depressive disorder.

Conditions

Interventions

DRUG

Aripiprazole (Fixed dose)

administered orally once daily, 3 mg daily, 6 weeks

DRUG

Aripiprazole (Titrated dose)

administered orally once daily, 3 to 15 mg daily, 6 weeks

DRUG

Placebo

administered orally once daily, 6 weeks

Sponsors & Collaborators

  • Otsuka Pharmaceutical Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Katsuhisa Saito · OPC-J

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
74 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-03-31
Primary Completion
2012-07-31
Completion
2012-07-31

Countries

  • Japan

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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 NCT00876343 on ClinicalTrials.gov