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

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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00514865

Enrollment

278

Registered

2007-08-10

Start date

2007-06-13

Completion date

2008-06-30

Last updated

2023-11-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Major Depressive Disorder

Keywords

ONO-2333Ms, Major Depressive Disorder

Brief summary

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

Interventions

DRUGONO-2333Ms Experimental 2

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

DRUGPlacebo

0 mg QD(once a day) for 8 weeks

DRUGONO-2333Ms Experimental 1

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 55 Years

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

Design outcomes

Primary

Measure	Time frame
Change from baseline to treatment endpoint in the MADRS total score	8 weeks

Secondary

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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026