At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Randomized, Multi-center, Double-blind, Placebo-controlled, Parallel-group Comparison Trial to Assess Efficacy and Safety of OPC-64005 in Patients With Major Depressive Disorder
In Brief
A Phase 2 clinical trial evaluating OPC-64005 20 mg , Once-daily, OPC-64005 10 mg , Once-daily, and 1 other intervention for Major Depressive Disorder. Completed, enrolled 273 participants across 1 site.
Detailed Summary
The objective of the trial is to compare the efficacy of OPC-64005 at 20 mg vs placebo and to assess the safety and pharmacokinetics of OPC-64005 at 10 and 20 mg in patients with major depressive disorder (MDD).The primary endpoint is the mean change from baseline in Montgomery-Åsberg Depression Rating Scale (MADRS) total score at Week 6 of the double-blind treatment period in the OPC-64005 20-mg group compared with the placebo group
Study Details
Timeline
Interventions
Active, High Dose
Active, Low Dose
Placebo