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

November 26, 2023 updated by: Ono Pharma USA Inc

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

278

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Georgia
      • Atlanta, Georgia, United States, 30329
        • Ono Pharma Investigtional Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 55 years (Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
placebo comparator
Drug: Placebo
0 mg QD(once a day) for 8 weeks
Experimental: Experimental 1
1-2 mg of ONO-2333
Drug: ONO-2333Ms Experimental 1
1-2 mg QD(once a day) for 8 weeks
Experimental: Experimental 2
5-10 mg of ONO-2333
Drug: ONO-2333Ms Experimental 2
5-10 mg QD(once a day) for 8 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change from baseline to treatment endpoint in the MADRS total score
Time Frame: 8 weeks
8 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Change from baseline to treatment endpoint in the HAM-D17, QIDS-SR16, CGI-S, CGI-I, PGI score
Time Frame: 8 weeks
8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ono Pharma USA Inc

Investigators

  • Study Director: Katsutoshi Hatakeyama, M.S., Ono Pharma USA Inc

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 13, 2007

Primary Completion (Actual)

April 1, 2008

Study Completion (Actual)

June 1, 2008

Study Registration Dates

First Submitted

August 7, 2007

First Submitted That Met QC Criteria

August 8, 2007

First Posted (Estimated)

August 10, 2007

Study Record Updates

Last Update Posted (Actual)

November 28, 2023

Last Update Submitted That Met QC Criteria

November 26, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ONO-2333POU007

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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