An Eight-week Study of Saredutant and Escitalopram 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

643 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-09-30

Study Completion Date

2009-01-31

Brief Summary

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The main purpose of this study is to evaluate the efficacy of saredutant 100mg once daily in combination with escitalopram 10mg once daily compared to saredutant placebo in combination with escitalopram 10mg once daily in patients with major depressive disorder. This study also includes a double-placebo group (saredutant placebo in combination with escitalopram placebo).

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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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Saredudant/Escitalopram

Saredutant 100 mg and Escitalopram 10 mg once daily for a maximum of 8 weeks

Group Type EXPERIMENTAL

saredutant (SR48968)

Intervention Type DRUG

oral administration, capsules

escitalopram

Intervention Type DRUG

oral administration, capsules

Placebo and Escitalopram

Placebo for saredutant and Escitalopram 10 mg once daily for a maximum of 8 weeks

Group Type ACTIVE_COMPARATOR

escitalopram

Intervention Type DRUG

oral administration, capsules

placebo

Intervention Type DRUG

oral administration, capsules

Placebo

Placebo for saredutant and Placebo for Escitalopram once daily for one week during the screening phase and for a maximum of 8 weeks during 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

escitalopram

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

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No