At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 155 enrolled
Drug / intervention
OPC-14597 (Aripiprazole)drug
Likely dose
OPC-14597 (Aripiprazole) 15 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.
Long-Term Administration Study of Aripiprazole as an Adjunctive Therapy in Patients With Major Depressive Disorder
In Brief
A Phase 3 clinical trial evaluating OPC-14597 (Aripiprazole) for Major Depressive Disorder. Completed, enrolled 155 participants across 8 sites.
Detailed Summary
To examine the safety and efficacy of long term administration of aripiprazole as an adjunctive therapy, co-administered with either a selective serotonin reuptake inhibitor (SSRI) or a selective-norepinephrine reuptake inhibitor (SNRI), in subjects 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 16, 2009
Enrollment StartMar 1, 2009
Primary CompletionJul 1, 2012
TodayJul 2, 2026
Enrollment to primary: 3.3 yearsPosted 17.2 years ago
Interventions
OPC-14597 (Aripiprazole)drug
administered orally once daily, 3 to 15 mg daily, 52 weeks