Status:
COMPLETED
An Eight-Week Study Evaluating the Efficacy and Tolerability of Two Doses of SSR149415 in Outpatients With Major Depressive Disorder
Lead Sponsor:
Sanofi
Conditions:
Depressive Disorder
Eligibility:
All Genders
18-64 years
Phase:
PHASE2
Brief Summary
The objective is to evaluate the efficacy and safety of two doses of SSR149415 (250 mg and 100 mg twice daily) compared to placebo and escitalopram 10 mg once daily in outpatients with major depressiv...
Eligibility Criteria
Inclusion
- Diagnosis of major depressive disorder, as defined by DSM-IV criteria and confirmed by the semi-structured MINI, recurrent episode.
Exclusion
- 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, anxiolytics, or mood-stabilizer (lithium, anticonvulsants) within 1 week except as allowed in the protocol.
- The investigator will evaluate whether there are other reasons why a patient may not participate
Key Trial Info
Start Date :
July 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2007
Estimated Enrollment :
319 Patients enrolled
Trial Details
Trial ID
NCT00358631
Start Date
July 1 2006
End Date
December 1 2007
Last Update
April 13 2009
Active Locations (1)
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1
Sanofi-Aventis
Bridgewater, New Jersey, United States, 08807