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

This study has been completed.
Information provided by:
Sanofi Identifier:
First received: September 18, 2007
Last updated: February 13, 2009
Last verified: February 2009
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).

Condition Intervention Phase
Major Depressive Disorder
Drug: saredutant (SR48968)
Drug: escitalopram
Drug: placebo
Phase 3

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

Resource links provided by NLM:

Further study details as provided by Sanofi:

Primary Outcome Measures:
  • Change from baseline in Hamilton Depression Rating Scale total score [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change from baseline in the Changes in Sexual Functioning Questionnaire total score [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
  • Change from baseline in the Clinical Global Impression severity of illness score [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 615
Study Start Date: September 2007
Study Completion Date: January 2009
Primary Completion Date: January 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Group 1 Drug: saredutant (SR48968)
oral administration
Drug: escitalopram
oral administration
Active Comparator: Group 2 Drug: escitalopram
oral administration
Placebo Comparator: Group 3 Drug: placebo
oral administration


Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00531622

United States, New Jersey
Sanofi-Aventis Administrative Office
Bridgewater, New Jersey, United States, 08807
Sanofi-Aventis Administrative Office
Buenos Aires, Argentina
Sanofi-Aventis Administrative Office
Helsinki, Finland
Sanofi-Aventis Administrative Office
Paris, France
Sanofi-Aventis Administrative Office
Mexico, Mexico
Sanofi-Aventis Administrative Office
Bromma, Sweden
Sponsors and Collaborators
Study Director: ICD Sanofi
  More Information

Additional Information:
Responsible Party: ICD Study Director, sanofi-aventis Identifier: NCT00531622     History of Changes
Other Study ID Numbers: EFC10290  EudraCT 2007-003159-36 
Study First Received: September 18, 2007
Last Updated: February 13, 2009
Health Authority: United States: Food and Drug Administration
Mexico: Ministry of Health
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by Sanofi:
Major Depressive Episode

Additional relevant MeSH terms:
Depressive Disorder
Depressive Disorder, Major
Behavioral Symptoms
Mental Disorders
Mood Disorders
Anti-Dyskinesia Agents
Antidepressive Agents
Antidepressive Agents, Second-Generation
Antiparkinson Agents
Autonomic Agents
Central Nervous System Agents
Cholinergic Agents
Cholinergic Antagonists
Molecular Mechanisms of Pharmacological Action
Muscarinic Antagonists
Neurotransmitter Agents
Neurotransmitter Uptake Inhibitors
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Psychotropic Drugs
Serotonin Agents
Serotonin Uptake Inhibitors
Therapeutic Uses processed this record on April 27, 2016