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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00514865
First Posted: August 10, 2007
Last Update Posted: December 25, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Ono Pharmaceutical Co. Ltd ( Ono Pharma USA Inc )
  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
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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

Further study details as provided by Ono Pharmaceutical Co. Ltd ( Ono Pharma USA Inc ):

Primary Outcome Measures:
  • Change from baseline to treatment endpoint in the MADRS total score [ Time Frame: 8 weeks ]

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 ]

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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Ono Pharma USA Inc
ClinicalTrials.gov Identifier: NCT00514865     History of Changes
Other Study ID Numbers: ONO-2333POU007
First Submitted: August 7, 2007
First Posted: August 10, 2007
Last Update Posted: December 25, 2013
Last Verified: November 2013

Keywords provided by Ono Pharmaceutical Co. Ltd ( Ono Pharma USA Inc ):
ONO-2333Ms
Major Depressive Disorder

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


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