Placebo-Controlled Study of ONO-2333Ms in Patients With Recurrent Major Depressive Disorder

Phase 2

Completed

• Conditions: Major Depressive Disorder
• Interventions: Drug: Placebo; Drug: ONO-2333Ms Experimental 1; Drug: ONO-2333Ms Experimental 2

• Registration Number: NCT00514865
• Lead Sponsor: Ono Pharma USA Inc

Brief Summary

The purpose of this study is to evaluate the safety and efficacy of ONO-2333Ms in patients with Recurrent Major Depressive Disorder

Detailed Description

Not available

Study Timeline

• Study Start: 2007-06-13
• Study First Submitted: 2007-08-07
• Study First Submitted QC: 2007-08-08
• Study First Posted: 2007-08-10
• Primary Completion: 2008-04
• Study Completion: 2008-06
• Disposition First Submitted: 2013-11-30
• Disposition First Submitted QC: 2013-11-30
• Disposition First Posted: 2013-12-25
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-26
• Last Update Posted: 2023-11-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 278

Inclusion Criteria

• Diagnosed with recurrent major depressive disorder

Exclusion Criteria

• Patients with treatment resistance for depression
• History of alcohol abuse/dependence, substance abuse/dependence within 6 months
• Has clinically significant unstable medical condition
• Has significant risk of suicide

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	placebo comparator
Experimental 1	ONO-2333Ms Experimental 1	1-2 mg of ONO-2333
Experimental 2	ONO-2333Ms Experimental 2	5-10 mg of ONO-2333

Primary Outcome Measures

Name	Time	Method
Change from baseline to treatment endpoint in the MADRS total score	8 weeks

Secondary Outcome Measures

Name	Time	Method
Change from baseline to treatment endpoint in the HAM-D17, QIDS-SR16, CGI-S, CGI-I, PGI score	8 weeks

Trial Locations

Locations (1)

Ono Pharma Investigtional Site; 🇺🇸 Atlanta, Georgia, United States