An Eight-week Study of Saredutant and Paroxetine as Combination Treatment for Major Depressive Disorder

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

PHASE3

Total Enrollment

825 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-02-29

Study Completion Date

2009-02-28

Brief Summary

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The main purpose of this study is to evaluate the efficacy of saredutant 100mg or 30mg once daily in combination with paroxetine 20mg once daily compared to saredutant placebo in combination with paroxetine 20mg once daily in patients with major depressive disorder. The study also includes a double-placebo group (saredutant placebo in combination with paroxetine placebo).

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Detailed Description

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Conditions

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Depressive Disorder, Major

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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Saredutant 100mg and Paroxetine 20 mg

combined saredutant 100mg and paroxetine 20mg once daily for a maximum of 8 weeks

Group Type EXPERIMENTAL

saredutant (SR48968)

Intervention Type DRUG

oral administration,capsules

paroxetine

Intervention Type DRUG

oral administration, capsules

Saredutant 30mg and Paroxetine 20mg

combined saredutant 30mg and paroxetine 20mg once daily for a maximum of 8 weeks

Group Type EXPERIMENTAL

saredutant (SR48968)

Intervention Type DRUG

oral administration,capsules

paroxetine

Intervention Type DRUG

oral administration, capsules

Paroxetine 20 mg and saredutant placebo

paroxetine 20mg and saredutant placebo once daily for a maximum of 8 weeks

Group Type ACTIVE_COMPARATOR

paroxetine

Intervention Type DRUG

oral administration, capsules

placebo

Intervention Type DRUG

oral administration, capsules

Placebo

Saredutant placebo and paroxetine placebo once daily for one week during screening period and maximum of 8 weeks for the active phase

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type DRUG

oral administration, capsules

Interventions

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saredutant (SR48968)

oral administration,capsules

Intervention Type DRUG

paroxetine

oral administration, capsules

Intervention Type DRUG

placebo

oral administration, capsules

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Outpatients with recurrent Major Depressive Disorder

Exclusion Criteria

* Symptoms of current depressive episode for less than 30 days or more than 2 years
* Mild depression, as measured by standard clinical research scales
* Significant suicide risk
* Lack of sexual activity (including masturbation)
* Other psychiatric conditions that would obscure the results of the study
* History of failure to respond to antidepressant treatment
* Pregnancy or breast-feeding

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No