An Eight-Week Study to Evaluate the Efficacy and Safety of Saredutant in Patients With Depression
Tracking Information | |||||
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First Received Date ICMJE | November 7, 2005 | ||||
Last Updated Date | December 22, 2008 | ||||
Start Date ICMJE | December 2004 | ||||
Primary Completion Date | December 2006 (final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures ICMJE |
The primary outcome of the study is the change from baseline to Day 56 of treatment in the Hamilton Depression Rating Scale (HAM-D) total score. | ||||
Original Primary Outcome Measures ICMJE | Same as current | ||||
Change History | Complete list of historical versions of study NCT00256113 on ClinicalTrials.gov Archive Site | ||||
Current Secondary Outcome Measures ICMJE |
The main secondary outcomes are the changes from baseline to Day 56 of treatment in the HAM-D depressed mood item, the Montgomery Asberg Depression Rating Scale total, and the Clinical Global Impression Severity of Illness scores. | ||||
Original Secondary Outcome Measures ICMJE | Same as current | ||||
Current Other Outcome Measures ICMJE | |||||
Original Other Outcome Measures ICMJE | |||||
Descriptive Information | |||||
Brief Title ICMJE | An Eight-Week Study to Evaluate the Efficacy and Safety of Saredutant in Patients With Depression | ||||
Official Title ICMJE | An Eight-Week, Multicenter, Double-Blind, Placebo-Controlled Study Evaluating the Efficacy, Safety, and Tolerability of One Fixed 100 mg Dose of Saredutant in Patients With Major Depressive Disorder | ||||
Brief Summary | The purpose of the study is to evaluate the efficacy and safety of saredutant (or SR48968C) in patients with depression. The primary objective is to evaluate the efficacy of a 100 mg dose of saredutant compared to placebo in patients with depression. The secondary objectives are to evaluate the safety of saredutant, to evaluate the efficacy of saredutant on disability and quality of life in patients with depression, and to evaluate blood levels of saredutant. |
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Detailed Description | The study is a multicenter, multicountry, randomized, parallel-group, double blind, placebo and paroxetine-controlled study consisting of three segments (A, B, and C). Segment A is a 1-week, placebo, single-blind period and Segment B is an 8-week, double blind period. Patients completing Segment B may be eligible for enrollment into Segment C, a 44-week, double blind extension. All randomized patients must complete a post-study visit 1 week after intake of the last dose of study medication. |
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Study Type ICMJE | Interventional | ||||
Study Phase | Phase 3 | ||||
Study Design ICMJE | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment |
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Condition ICMJE | Depressive Disorder | ||||
Intervention ICMJE | Drug: Saredutant succinate (SR48968C) | ||||
Study Arm (s) | |||||
Publications * | |||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status ICMJE | Completed | ||||
Enrollment ICMJE | 467 | ||||
Completion Date | December 2006 | ||||
Primary Completion Date | December 2006 (final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Gender | Both | ||||
Ages | 18 Years to 64 Years | ||||
Accepts Healthy Volunteers | No | ||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
Location Countries ICMJE | Canada, Chile, Croatia, Czech Republic, Estonia, Germany, Mexico, Portugal | ||||
Administrative Information | |||||
NCT Number ICMJE | NCT00256113 | ||||
Other Study ID Numbers ICMJE | EFC5575 | ||||
Has Data Monitoring Committee | |||||
Responsible Party | ICD Study Director, sanofi-aventis | ||||
Study Sponsor ICMJE | Sanofi-Aventis | ||||
Collaborators ICMJE | |||||
Investigators ICMJE |
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Information Provided By | Sanofi-Aventis | ||||
Verification Date | December 2008 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |