NCT00876343

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

Placebo-Controlled, Double-Blind, Parallel Group-Comparison Study of Aripiprazole as an Adjunctive Therapy in Patients With Major Depressive Disorder

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 586 (actual)
• Sponsor: Otsuka Pharmaceutical Co., Ltd. · Industry
• Sex: All
• Age: 20 Years – 74 Years
• Healthy volunteers: Not accepted

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

• Major Depressive Disorder

Interventions

Type	Name	Description
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

Timeline

• Start date: 2009-03-01
• Primary completion: 2012-07-01
• Completion: 2012-07-01
• First posted: 2009-04-06
• Last updated: 2014-02-10
• Results posted: 2014-02-10

Locations

8 sites across 1 country: Japan