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

NCT ID: NCT00514865

Last Updated: 2023-11-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

278 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-06-13

Study Completion Date

2008-06-30

Brief Summary

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

Detailed Description

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Conditions

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Major Depressive Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Experimental 1

1-2 mg of ONO-2333

Group Type EXPERIMENTAL

ONO-2333Ms Experimental 1

Intervention Type DRUG

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

Experimental 2

5-10 mg of ONO-2333

Group Type EXPERIMENTAL

ONO-2333Ms Experimental 2

Intervention Type DRUG

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

Placebo

placebo comparator

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

0 mg QD(once a day) for 8 weeks

Interventions

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ONO-2333Ms Experimental 2

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

Intervention Type DRUG

Placebo

0 mg QD(once a day) for 8 weeks

Intervention Type DRUG

ONO-2333Ms Experimental 1

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

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ono Pharma USA Inc

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Katsutoshi Hatakeyama, M.S.

Role: STUDY_DIRECTOR

Ono Pharma USA Inc

Locations

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Ono Pharma Investigtional Site

Atlanta, Georgia, United States

Site Status

Countries

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United States

Other Identifiers

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ONO-2333POU007

Identifier Type: -

Identifier Source: org_study_id