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Sponsored by: |
Ono Pharma |
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Information provided by: | Ono Pharma |
ClinicalTrials.gov Identifier: | NCT00514865 |
The purpose of this study is to evaluate the safety and efficacy of ONO-2333Ms in patients with Recurrent Major Depressive Disorder
Condition | Intervention | Phase |
---|---|---|
Major Depressive Disorder |
Drug: ONO-2333Ms |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
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 |
Enrollment: | 278 |
Study Start Date: | June 2007 |
Study Completion Date: | June 2008 |
Primary Completion Date: | April 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
E1: Experimental
low dose
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Drug: ONO-2333Ms
1-2 mg QD for 8 weeks
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E2: Experimental
high dose
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Drug: ONO-2333Ms
5-10 mg QD for 8 weeks
|
P: Placebo Comparator
placebo comparator
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Drug: ONO-2333Ms
0 mg QD for 8 weeks
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Ages Eligible for Study: | 18 Years to 55 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Responsible Party: | Ono Pharma USA, Inc. ( Brenda Souza, Drug Development Coordinator ) |
Study ID Numbers: | ONO-2333POU007 |
Study First Received: | August 7, 2007 |
Last Updated: | November 12, 2008 |
ClinicalTrials.gov Identifier: | NCT00514865 History of Changes |
Health Authority: | United States: Food and Drug Administration |
ONO-2333Ms Major Depressive Disorder |
Depression Mental Disorders Mood Disorders Depressive Disorder, Major |
Depressive Disorder Recurrence Behavioral Symptoms |
Disease Attributes Pathologic Processes Disease Depression Mental Disorders |
Mood Disorders Depressive Disorder, Major Depressive Disorder Recurrence Behavioral Symptoms |