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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Ono Pharmaceutical Co. Ltd ( Ono Pharma USA Inc )
ClinicalTrials.gov Identifier:
NCT00514865
First received: August 7, 2007
Last updated: October 11, 2012
Last verified: October 2012
History of Changes
  Purpose

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 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by NLM:

MedlinePlus related topics: Depression
U.S. FDA Resources

Further study details as provided by Ono Pharmaceutical Co. Ltd:

Primary Outcome Measures:
  • Change from baseline to treatment endpoint in the MADRS total score [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change from baseline to treatment endpoint in the HAM-D17, QIDS-SR16, CGI-S, CGI-I, PGI score [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]

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
Experimental: E1
1-2 mg of ONO-2333
 Drug: ONO-2333Ms
1-2 mg QD for 8 weeks
Experimental: E2
5-10 mg of ONO-2333
 Drug: ONO-2333Ms
5-10 mg QD for 8 weeks
Placebo Comparator: P
placebo comparator
 Drug: ONO-2333Ms
0 mg QD for 8 weeks

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00514865

Locations
United States, Georgia
Ono Pharma Investigtional Site
Atlanta, Georgia, United States, 30329
Sponsors and Collaborators
Ono Pharma USA Inc
Investigators
Study Director: Katsutoshi Hatakeyama, M.S. Ono Pharma USA Inc
  More Information

No publications provided

Responsible Party: Ono Pharmaceutical Co. Ltd ( Ono Pharma USA Inc )
ClinicalTrials.gov Identifier: NCT00514865     History of Changes
Other Study ID Numbers: ONO-2333POU007
Study First Received: August 7, 2007
Last Updated: October 11, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Ono Pharmaceutical Co. Ltd:
ONO-2333Ms
Major Depressive Disorder

Additional relevant MeSH terms:
Depressive Disorder
Depression
Depressive Disorder, Major
Recurrence
Mood Disorders
 Mental Disorders
Behavioral Symptoms
Disease Attributes
Pathologic Processes

ClinicalTrials.gov processed this record on May 16, 2013