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

This study has been completed.
Sponsor:
Information provided by:
Sanofi
ClinicalTrials.gov Identifier:
NCT00531622
First received: September 18, 2007
Last updated: February 13, 2009
Last verified: February 2009
  Purpose

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

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
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.

  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 ClinicalTrials.gov identifier: 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
  More Information

Additional Information:
No publications provided

Responsible Party: ICD Study Director, sanofi-aventis
ClinicalTrials.gov 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:
Depression
Major Depressive Episode
Antidepressant

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

ClinicalTrials.gov processed this record on July 24, 2014