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

Ono Pharma USA Inc278 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

278

Conditions

Major Depressive Disorder

Interventions

ONO-2333Ms Experimental 2DRUG

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

PlaceboDRUG

0 mg QD(once a day) for 8 weeks

ONO-2333Ms Experimental 1DRUG

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 55 Years

Medical Language ↔ Plain English

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

Locations (1)

Ono Pharma Investigtional Site

Atlanta, Georgia, United States

Outcomes

Primary Outcomes

Change from baseline to treatment endpoint in the MADRS total score

Time frame: 8 weeks

Secondary Outcomes

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

Time frame: 8 weeks

Data from ClinicalTrials.gov

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