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OpenTrials
Completed

NCT Number: NCT00514865

Placebo-Controlled Study 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

Completed

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Key information

Conditions

Major Depressive Disorder Depressive Disorder Depressive Disorder, Major Mental Disorders Mood Disorders

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Ono Pharma Investigtional Site

Atlanta, Georgia, 30329, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ONO-2333Ms Experimental 2

Drug

5-10 mg QD(once a day) for 8 weeks

Placebo

Drug

0 mg QD(once a day) for 8 weeks

ONO-2333Ms Experimental 1

Drug

1-2 mg QD(once a day) for 8 weeks

Primary outcomes

  1. Change from baseline to treatment endpoint in the MADRS total score

    Time frame: 8 weeks

Secondary outcomes

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

    Time frame: 8 weeks

Sponsors and collaborators

Lead sponsor

Ono Pharma USA Inc

Industry

Registry information

Official study 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

Important dates

Study start
2007
Primary completion
2008
Study completion
2008
First posted
Aug 10, 2007
Registry last updated
Nov 28, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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