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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 February 2015 |
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Main ID: |
NCT00825058 |
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Date of registration:
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16/01/2009 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Efficacy and Safety of SR58611 Compared to Placebo and Paroxetine
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Scientific title:
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A Double-Blind, Multicenter Study Evaluating the Efficacy and Safety of One Fixed Dose of SR58611A (700 mg/Day) Versus Placebo and Paroxetine (20 mg/Day) in Patients With a Recurrent Major Depressive Episode. |
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Date of first enrolment:
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November 2003 |
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Target sample size:
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317 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00825058 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
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Phase:
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Phase 3
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Countries of recruitment
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Bulgaria
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Croatia
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Czech Republic
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Estonia
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France
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Montenegro
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Netherlands
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Serbia
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Contacts
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Name:
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ICD CSD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Sanofi |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- patients suffering from a recurrent major depressive episode of at least moderate
intensity (DSM-IV)
- patients have been hospitalized for the treatment of a previous episode, or a
previous episode required antidepressant treatment(s)at the recommended dose level
for at least 2 months.
- the duration of the current episode is of at least six weeks unless the severity of
symptoms justifies shorter duration
Age minimum:
18 Years
Age maximum:
65 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Major Depressive Disorders
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Intervention(s)
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Drug: paroxetine
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Drug: placebo
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Drug: amibegron (SR58611A)
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Primary Outcome(s)
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change from baseline of the total score of the HAM-D 17 items.
[Time Frame: 6 weeks]
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Secondary Outcome(s)
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electrocardiogram (ECG) parameters, change in vital signs and body weight
[Time Frame: 6 weeks]
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clinical monitoring of adverse events (AEs)
[Time Frame: 6 weeks]
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laboratory parameters
[Time Frame: 6 weeks]
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patient global impression (PGI) improvement score
[Time Frame: 6 weeks]
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HAM-D responders and remitters
[Time Frame: 6 weeks]
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MADRS total score
[Time Frame: 6 weeks]
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clinical global impression (CGI) severity and improvement scores
[Time Frame: 6 weeks]
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HAM-A total score and subscores
[Time Frame: 6 weeks]
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HAM-D subscores
[Time Frame: 6 weeks]
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social and occupational functioning assessment scale (SOFAS) score
[Time Frame: 6 weeks]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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