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

Sanofi643 enrolled

Overview

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).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

643

Conditions

Major Depressive Disorder

Interventions

saredutant (SR48968)DRUG

oral administration, capsules

escitalopramDRUG

oral administration, capsules

placeboDRUG

oral administration, capsules

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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.

Locations (6)

Sanofi-Aventis Administrative Office

Bridgewater, New Jersey, United States

Sanofi-Aventis Administrative Office

Buenos Aires, Argentina

Sanofi-Aventis Administrative Office

Helsinki, Finland

Sanofi-Aventis Administrative Office

Paris, France

Outcomes

Primary Outcomes

Change from baseline to Day 56 in Hamilton depression rating scale (HAM-D) total score

Time frame: Baseline, Day 56

Change from Baseline to Day 56 in the CGI-S Severity of Illness score

Time frame: Baseline, Day 56

Secondary Outcomes

Change from baseline to Day 56 in the Clinical Global Impression (CGI) severity of illness score

Time frame: Baseline, Day 56

Change from baseline to Day 56 in HAM-D depressed mood item scores.

Time frame: Baseline, Day 56

Percentage of patients demonstrating a treatment response

response is defined as a reduction of at least 50% in HAM-D total score between baseline and any post-baseline assessment

Time frame: Day 56

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.