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

Major Depressive Disorder Clinical Trial

Official title:

An Eight-Week, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy, Safety, and Tolerability of Saredutant 100 mg Once Daily in Combination With Escitalopram 10 mg Once Daily in Patients With Major Depressive Disorder

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00531622
• Other study ID #: EFC10290
• Secondary ID: EudraCT 2007-003
• Status: Completed
• Phase: Phase 3
• First received: September 18, 2007
• Last updated: February 13, 2009
• Start date: September 2007
• Est. completion date: January 2009

Study information

• Verified date: February 2009
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationMexico: Ministry of HealthFrance: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial Summary

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 615
• Est. completion date: January 2009
• Est. primary completion date: January 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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.

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Depressive Disorder, Major
• Major Depressive Disorder

Intervention

Drug:
• saredutant (SR48968)
oral administration
• escitalopram
oral administration
• placebo
oral administration

Locations

Country	Name	City	State
Argentina	Sanofi-Aventis Administrative Office	Buenos Aires
Finland	Sanofi-Aventis Administrative Office	Helsinki
France	Sanofi-Aventis Administrative Office	Paris
Mexico	Sanofi-Aventis Administrative Office	Mexico
Sweden	Sanofi-Aventis Administrative Office	Bromma
United States	Sanofi-Aventis Administrative Office	Bridgewater	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
Sanofi

Countries where clinical trial is conducted

United States,  Argentina,  Finland,  France,  Mexico,  Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline in Hamilton Depression Rating Scale total score		8 weeks	No
Secondary	Change from baseline in the Changes in Sexual Functioning Questionnaire total score		8 weeks	No
Secondary	Change from baseline in the Clinical Global Impression severity of illness score		8 weeks	No

External Links

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