An Eight-week Study of Saredutant and Paroxetine as Combination Treatment for Major Depressive Disorder (COMPASS)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Sanofi
ClinicalTrials.gov Identifier:
NCT00629551
First received: February 26, 2008
Last updated: April 26, 2016
Last verified: April 2016

February 26, 2008
April 26, 2016
February 2008
February 2009   (final data collection date for primary outcome measure)
  • Change from baseline in the Hamilton Depression Rating Scale (HAM-D) total score [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
  • Change from Baseline in the Changes in Sexual Functioning Questionnaire (CSFQ) total score [ Time Frame: weeks ] [ Designated as safety issue: No ]
Change from baseline in Hamilton Depression Rating Scale total score [ Time Frame: 8 weeks ]
Complete list of historical versions of study NCT00629551 on ClinicalTrials.gov Archive Site
  • Change from baseline in the Clinical Global Impression severity of illness score [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
  • Change from baseline in the HAM-D depressed mood item scores [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
  • Change from baseline in the Changes in Sexual Functioning Questionnaire total score [ Time Frame: 8 weeks ]
  • Change from baseline in the Clinical Global Impression severity of illness score [ Time Frame: 8 weeks ]
Not Provided
Not Provided
 
An Eight-week Study of Saredutant and Paroxetine as Combination Treatment for Major Depressive Disorder
An Eight-week, Double-blind Study to Evaluate the Efficacy, Safety, and Tolerability of Two Fixed Doses of Saredutant (100 mg and 30 mg) Once Daily in Combination With Paroxetine 20 mg Once Daily Compared to Saredutant Placebo in Combination With Paroxetine 20 mg Once Daily in Patients With Major Depressive Disorder
The main purpose of this study is to evaluate the efficacy of saredutant 100mg or 30mg once daily in combination with paroxetine 20mg once daily compared to saredutant placebo in combination with paroxetine 20mg once daily in patients with major depressive disorder. The study also includes a double-placebo group (saredutant placebo in combination with paroxetine placebo).
Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Depressive Disorder, Major
  • Drug: saredutant (SR48968)
    oral administration,capsules
  • Drug: paroxetine
    oral administration, capsules
  • Drug: placebo
    oral administration, capsules
  • Experimental: Saredutant 100mg and Paroxetine 20 mg
    combined saredutant 100mg and paroxetine 20mg once daily for a maximum of 8 weeks
    Interventions:
    • Drug: saredutant (SR48968)
    • Drug: paroxetine
  • Experimental: Saredutant 30mg and Paroxetine 20mg
    combined saredutant 30mg and paroxetine 20mg once daily for a maximum of 8 weeks
    Interventions:
    • Drug: saredutant (SR48968)
    • Drug: paroxetine
  • Active Comparator: Paroxetine 20 mg and saredutant placebo
    paroxetine 20mg and saredutant placebo once daily for a maximum of 8 weeks
    Interventions:
    • Drug: paroxetine
    • Drug: placebo
  • Placebo Comparator: Placebo
    Saredutant placebo and paroxetine placebo once daily for one week during screening period and maximum of 8 weeks for the active phase
    Intervention: Drug: placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
825
February 2009
February 2009   (final data collection date for primary outcome measure)

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
Both
18 Years to 65 Years   (Adult)
No
Contact information is only displayed when the study is recruiting subjects
United States,   Chile,   Estonia,   Germany,   Korea, Republic of,   Mexico,   Russian Federation,   South Africa
 
NCT00629551
EFC10438, EudraCT 2007-003863-31
Yes
Not Provided
Not Provided
Sanofi
Sanofi
Not Provided
Study Director: ICD CSD Sanofi
Sanofi
April 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP