NCT04244253

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

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 273 (actual)
• Sponsor: Otsuka Pharmaceutical Co., Ltd. · Industry
• Sex: All
• Age: 20 Years – 64 Years
• Healthy volunteers: Not accepted

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

Conditions

• Major Depressive Disorder

Interventions

Type	Name	Description
DRUG	OPC-64005 20 mg , Once-daily	Active, High Dose
DRUG	OPC-64005 10 mg , Once-daily	Active, Low Dose
DRUG	Placebo, Once-daily	Placebo

Timeline

• Start date: 2020-03-03
• Primary completion: 2022-02-08
• Completion: 2022-02-25
• First posted: 2020-01-28
• Last updated: 2024-09-19
• Results posted: 2024-09-19

Locations

1 site across 1 country: Japan