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NCT00514865 Clinical Trial

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

Major Depressive Disorder Clinical Trial

Official title:
A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Safety and Efficacy of ONO-2333Ms in Patients With Recurrent Major Depressive Disorder

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00514865
Other study ID # ONO-2333POU007
Secondary ID
Status Completed
Phase Phase 2
First received
Last updated
Start date June 13, 2007
Est. completion date June 2008

Study information
Verified date November 2023
Source Ono Pharmaceutical Co. Ltd
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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

Recruitment information / eligibility
Status Completed
Enrollment 278
Est. completion date June 2008
Est. primary completion date April 2008
Accepts healthy volunteers No
Gender All
Age group 18 Years to 55 Years
Eligibility 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

Related Conditions & MeSH terms

Intervention

Drug:
• ONO-2333Ms Experimental 2
5-10 mg QD(once a day) for 8 weeks
• Placebo
0 mg QD(once a day) for 8 weeks
• ONO-2333Ms Experimental 1
1-2 mg QD(once a day) for 8 weeks

Locations
Country Name City State
United States Ono Pharma Investigtional Site Atlanta Georgia

Sponsors (1)
Lead Sponsor Collaborator
Ono Pharma USA Inc

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Change from baseline to treatment endpoint in the MADRS total score 8 weeks
Secondary Change from baseline to treatment endpoint in the HAM-D17, QIDS-SR16, CGI-S, CGI-I, PGI score 8 weeks
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