NCT00514865
Completed
Phase 2
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
ConditionsMajor Depressive Disorder
Overview
- Phase
- Phase 2
- Intervention
- ONO-2333Ms Experimental 1
- Conditions
- Major Depressive Disorder
- Sponsor
- Ono Pharma USA Inc
- Enrollment
- 278
- Locations
- 1
- Primary Endpoint
- Change from baseline to treatment endpoint in the MADRS total score
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
The purpose of this study is to evaluate the safety and efficacy of ONO-2333Ms in patients with Recurrent Major Depressive Disorder
Investigators
Eligibility Criteria
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
Arms & Interventions
Experimental 1
1-2 mg of ONO-2333
Intervention: ONO-2333Ms Experimental 1
Experimental 2
5-10 mg of ONO-2333
Intervention: ONO-2333Ms Experimental 2
Placebo
placebo comparator
Intervention: Placebo
Outcomes
Primary Outcomes
Change from baseline to treatment endpoint in the MADRS total score
Time Frame: 8 weeks
Secondary Outcomes
- Change from baseline to treatment endpoint in the HAM-D17, QIDS-SR16, CGI-S, CGI-I, PGI score(8 weeks)
Study Sites (1)
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