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

Sponsored by:	Ono Pharma
Information provided by:	Ono Pharma
ClinicalTrials.gov Identifier:	NCT00514865

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 II

MedlinePlus related topics: Depression

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

Further study details as provided by Ono Pharma:

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

Eligibility

Criteria

Inclusion Criteria:

Exclusion Criteria:

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

Investigators

Study Director:

Katsutoshi Hatakeyama, M.S.

Ono Pharma

More Information

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
Health Authority:	United States: Food and Drug Administration

Keywords provided by Ono Pharma:

ONO-2333Ms
Major Depressive Disorder

Study placed in the following topic categories:

Depression
Mental Disorders
Mood Disorders
Depressive Disorder, Major

Depressive Disorder
Recurrence
Behavioral Symptoms

Additional relevant MeSH terms:

Disease Attributes
Pathologic Processes
Disease

ClinicalTrials.gov processed this record on January 16, 2009