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

Sanofi

Status and phase: Completed; Phase 3

Conditions: Major Depressive Disorder

Treatments: Drug: saredutant (SR48968); Drug: escitalopram; Drug: placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00531622

EudraCT 2007-003159-36

EFC10290

Details and patient eligibility

About

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).

Enrollment: 643 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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643 participants in 3 patient groups, including a placebo group

Saredudant/Escitalopram

Experimental group

Description:

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

Treatment:

Drug: escitalopram

Drug: saredutant (SR48968)

Placebo and Escitalopram

Active Comparator group

Description:

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

Treatment:

Drug: escitalopram

Drug: placebo

Placebo

Placebo Comparator group

Description:

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

Treatment:

Drug: placebo