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

Primary Purpose

Major Depressive Disorder

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
ONO-2333Ms
ONO-2333Ms
ONO-2333Ms
Sponsored by
Ono Pharma USA Inc
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Major Depressive Disorder focused on measuring ONO-2333Ms, Major Depressive Disorder

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Ono Pharma Investigtional Site

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

E1

E2

P

Arm Description

1-2 mg of ONO-2333

5-10 mg of ONO-2333

placebo comparator

Outcomes

Primary Outcome Measures

Change from baseline to treatment endpoint in the MADRS total score

Secondary Outcome Measures

Change from baseline to treatment endpoint in the HAM-D17, QIDS-SR16, CGI-S, CGI-I, PGI score

Full Information

First Posted
August 7, 2007
Last Updated
November 30, 2013
Sponsor
Ono Pharma USA Inc
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1. Study Identification

Unique Protocol Identification Number
NCT00514865
Brief Title
Placebo-Controlled Study of ONO-2333Ms in Patients With Recurrent Major Depressive Disorder
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
Study Type
Interventional

2. Study Status

Record Verification Date
November 2013
Overall Recruitment Status
Completed
Study Start Date
June 2007 (undefined)
Primary Completion Date
April 2008 (Actual)
Study Completion Date
June 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ono Pharma USA Inc

4. Oversight

5. Study Description

Brief Summary
The purpose of this study is to evaluate the safety and efficacy of ONO-2333Ms in patients with Recurrent Major Depressive Disorder

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Major Depressive Disorder
Keywords
ONO-2333Ms, Major Depressive Disorder

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
278 (Actual)

8. Arms, Groups, and Interventions

Arm Title
E1
Arm Type
Experimental
Arm Description
1-2 mg of ONO-2333
Arm Title
E2
Arm Type
Experimental
Arm Description
5-10 mg of ONO-2333
Arm Title
P
Arm Type
Placebo Comparator
Arm Description
placebo comparator
Intervention Type
Drug
Intervention Name(s)
ONO-2333Ms
Intervention Description
5-10 mg QD for 8 weeks
Intervention Type
Drug
Intervention Name(s)
ONO-2333Ms
Intervention Description
0 mg QD for 8 weeks
Intervention Type
Drug
Intervention Name(s)
ONO-2333Ms
Intervention Description
1-2 mg QD for 8 weeks
Primary Outcome Measure Information:
Title
Change from baseline to treatment endpoint in the MADRS total score
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
Change from baseline to treatment endpoint in the HAM-D17, QIDS-SR16, CGI-S, CGI-I, PGI score
Time Frame
8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Katsutoshi Hatakeyama, M.S.
Organizational Affiliation
Ono Pharma USA Inc
Official's Role
Study Director
Facility Information:
Facility Name
Ono Pharma Investigtional Site
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30329
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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