At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 586 enrolled
Drug / intervention
Aripiprazole (Fixed dose) +2 moredrug
Likely dose
Aripiprazole (Fixed dose) 3 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Placebo-Controlled, Double-Blind, Parallel Group-Comparison Study of Aripiprazole as an Adjunctive Therapy in Patients With Major Depressive Disorder
In Brief
A Phase 3 clinical trial evaluating Aripiprazole (Fixed dose), Aripiprazole (Titrated dose), and 1 other intervention for Major Depressive Disorder. Completed, enrolled 586 participants across 8 sites.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMajor Depressive Disorder
CountriesJapan
Collaborators--
Timeline
Phase 3CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
Enrollment StartMar 2009
First PostedApr 2009
Primary CompletionJul 2012
TodayJul 2026
First PostedApr 6, 2009
Enrollment StartMar 1, 2009
Primary CompletionJul 1, 2012
TodayJul 2, 2026
Enrollment to primary: 3.3 yearsPosted 17.2 years ago
Interventions
Aripiprazole (Fixed dose)drug
administered orally once daily, 3 mg daily, 6 weeks
Aripiprazole (Titrated dose)drug
administered orally once daily, 3 to 15 mg daily, 6 weeks
Placebodrug
administered orally once daily, 6 weeks