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

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ClinicalTrials.gov Identifier: NCT00531622
Recruitment Status : Completed
First Posted : September 19, 2007
Last Update Posted : May 24, 2016
Sponsor:
Information provided by (Responsible Party):
Sanofi

Brief 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).

Condition or disease Intervention/treatment Phase
Major Depressive Disorder Drug: saredutant (SR48968) Drug: escitalopram Drug: placebo Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 643 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (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
Study Start Date : September 2007
Actual Primary Completion Date : January 2009
Actual Study Completion Date : January 2009

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. Change from baseline to Day 56 in Hamilton depression rating scale (HAM-D) total score [ Time Frame: Baseline, Day 56 ]
  2. Change from Baseline to Day 56 in the CGI-S Severity of Illness score [ Time Frame: Baseline, Day 56 ]

Secondary Outcome Measures :
  1. Change from baseline to Day 56 in the Clinical Global Impression (CGI) severity of illness score [ Time Frame: Baseline, Day 56 ]
  2. Change from baseline to Day 56 in HAM-D depressed mood item scores. [ Time Frame: Baseline, Day 56 ]
  3. 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



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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00531622


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

Responsible Party: Sanofi
ClinicalTrials.gov Identifier: NCT00531622     History of Changes
Other Study ID Numbers: EFC10290
EudraCT 2007-003159-36
First Posted: September 19, 2007    Key Record Dates
Last Update Posted: May 24, 2016
Last Verified: April 2016

Keywords provided by Sanofi:
Depression
Major Depressive Episode
Antidepressant

Additional relevant MeSH terms:
Disease
Depressive Disorder
Depression
Depressive Disorder, Major
Pathologic Processes
Mood Disorders
Mental Disorders
Behavioral Symptoms
Citalopram
Dexetimide
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
Parasympatholytics
Autonomic Agents
Peripheral Nervous System Agents
Muscarinic Antagonists
Cholinergic Antagonists
Cholinergic Agents