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: November 30, 2013
Last verified: November 2013
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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: November 30, 2013
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 September 14, 2014