Depressive Disorder Clinical Trial
— LENAOfficial title:
An Eight-Week, Multicenter, Double-Blind, Placebo- and Paroxetine-Controlled Study Evaluating the Efficacy, and Tolerability of Two Fixed Doses of SSR149415 (250 mg Bid and 100 mg Bid) in Patients With Major Depressive Disorder
The purpose of the study is to evaluate the efficacy of SSR149415 in the treatment of Major
Depressive Disorder, defined as a change from baseline to visit 7 in the Hamilton Depression
Rating Scale.
To evaluate the tolerability, safety and efficacy on disability and quality of life in
patients with major depressive disorder.To evaluate plasma concentrations of SSR149415.
Status | Completed |
Enrollment | 324 |
Est. completion date | September 2007 |
Est. primary completion date | September 2007 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 64 Years |
Eligibility |
Inclusion Criteria: - Diagnosis of major depressive disorder, recurrent, as defined by Diagnostic and Statistical Manual of Mental Disorders, 4th edition, Text Revision (DSM-IV-TR) criteria (296.3) and confirmed by the semi-structured Mini International Neuropsychiatric Interview (MINI) Exclusion Criteria: - Total score of less than 24 on the MADRS. - HAM-D total score less than 18. - Duration of the current depressive episode less than 1 month or greater than 2 years. - Patients with a history or presence of bipolar disorders or psychotic disorders. - Patients with alcohol dependence or abuse or substance dependence or abuse in the past 12 months except nicotine or caffeine dependence. - Patients who have used the following prior to entry into Acute Phase: antipsychotics within 3 months, fluoxetine within 1 month, MAOIs within 2 weeks, other antidepressants, or mood-stabilizer (lithium, anticonvulsants) within 1 week. The investigator will evaluate whether there are other reasons why a patient may not participate |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Argentina | Sanofi-Aventis Administrative Office | Buenos Aires | |
Bulgaria | Sanofi-Aventis Administrative Office | Sofia | |
Canada | Sanofi-Aventis Administrative Office | Laval | |
Chile | Sanofi-Aventis Administrative Office | Santiago de Chile | |
Croatia | Sanofi-Aventis Administrative Office | Zagreb | |
Mexico | Sanofi-Aventis Administrative Office | Mexico | |
Russian Federation | Sanofi-Aventis Administrative Office | Moscow |
Lead Sponsor | Collaborator |
---|---|
Sanofi |
Argentina, Bulgaria, Canada, Chile, Croatia, Mexico, Russian Federation,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | The primary efficacy endpoint is the change from baseline to Day 56 in the 17-item Hamilton Depression Rating Scale (HAM-D) total score | |||
Secondary | The main secondary endpoints are the changes from baseline to Day 56 in the HAM-D depressed mood item, Montgomery-Asberg Depression Rating Scale (MADRS) total, and Clinical Global Impression (CGI) Severity of Illness scores. |
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