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

This study has been completed.
Information provided by (Responsible Party):
Sanofi Identifier:
First received: September 18, 2007
Last updated: April 25, 2016
Last verified: April 2016
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 (Participant, Care Provider, 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 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 Outcome Measures:
  • 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 [ Time Frame: Day 56 ]
    response is defined as a reduction of at least 50% in HAM-D total score between baseline and any post-baseline assessment

Enrollment: 643
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: Saredudant/Escitalopram
Saredutant 100 mg and Escitalopram 10 mg once daily for a maximum of 8 weeks
Drug: saredutant (SR48968)
oral administration, capsules
Drug: escitalopram
oral administration, capsules
Active Comparator: Placebo and Escitalopram
Placebo for saredutant and Escitalopram 10 mg once daily for a maximum of 8 weeks
Drug: escitalopram
oral administration, capsules
Drug: placebo
oral administration, capsules
Placebo Comparator: 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
Drug: placebo
oral administration, capsules


Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
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

Responsible Party: Sanofi Identifier: NCT00531622     History of Changes
Other Study ID Numbers: EFC10290
EudraCT 2007-003159-36
Study First Received: September 18, 2007
Last Updated: April 25, 2016

Keywords provided by Sanofi:
Major Depressive Episode

Additional relevant MeSH terms:
Depressive Disorder
Depressive Disorder, Major
Pathologic Processes
Mood Disorders
Mental Disorders
Behavioral Symptoms
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Serotonin Agents
Physiological Effects of Drugs
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs
Antiparkinson Agents
Anti-Dyskinesia Agents
Autonomic Agents
Peripheral Nervous System Agents
Muscarinic Antagonists
Cholinergic Antagonists
Cholinergic Agents processed this record on July 21, 2017