Depressive Disorder, Major Clinical Trial
— COMPASSOfficial title:
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).
Status | Completed |
Enrollment | 820 |
Est. completion date | February 2009 |
Est. primary completion date | February 2009 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 65 Years |
Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Chile | Sanofi-Aventis Administrative Office | Santiago | |
Estonia | Sanofi-Aventis Administrative Office | Tallinn | |
Germany | Sanofi-Aventis Administrative Office | Berlin | |
Korea, Republic of | Sanofi-Aventis Administrative Office | Seoul | |
Mexico | Sanofi-Aventis Administrative Office | Mexico | |
Russian Federation | Sanofi-Aventis Administrative Office | Moscow | |
South Africa | Sanofi-Aventis Administrative Office | Midrand | |
United States | Sanofi-Aventis Administrative Office | Bridgewater | New Jersey |
Lead Sponsor | Collaborator |
---|---|
Sanofi |
United States, Chile, Estonia, Germany, Korea, Republic of, Mexico, Russian Federation, South Africa,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change from baseline in Hamilton Depression Rating Scale total score | 8 weeks | No | |
Secondary | Change from baseline in the Changes in Sexual Functioning Questionnaire total score | 8 weeks | No | |
Secondary | Change from baseline in the Clinical Global Impression severity of illness score | 8 weeks | No |
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