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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Sanofi
ClinicalTrials.gov Identifier:
NCT00531622
First received: September 18, 2007
Last updated: April 25, 2016
Last verified: April 2016
  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 to Day 56 in Hamilton depression rating scale (HAM-D) total score [ Time Frame: Baseline, Day 56 ] [ Designated as safety issue: No ]
  • Change from Baseline to Day 56 in the CGI-S Severity of Illness score [ Time Frame: Baseline, Day 56 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change from baseline to Day 56 in the Clinical Global Impression (CGI) severity of illness score [ Time Frame: Baseline, Day 56 ] [ Designated as safety issue: No ]
  • Change from baseline to Day 56 in HAM-D depressed mood item scores. [ Time Frame: Baseline, Day 56 ] [ Designated as safety issue: No ]
  • Percentage of patients demonstrating a treatment response [ Time Frame: Day 56 ] [ Designated as safety issue: No ]
    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

  Eligibility

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

Responsible Party: Sanofi
ClinicalTrials.gov 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
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:
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

ClinicalTrials.gov processed this record on August 25, 2016