A Phase 2 Trial of OPC-64005 for Major Depressive Disorder

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

Timeline

Start

2020-03-03

Primary completion

2022-02-08

Completion

2022-02-25

Outcome

Missed primary endpoint

registry analysis (superiority test); OPC-64005 20-mg vs Placebo; p = 0.288; Difference of score -1.1 (95% CI -3.3 to 1.0); Mixed-model repeated measures NCT04244253 ↗

Drugs

Indications