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An Eight-Week Study Evaluating the Efficacy and Tolerability of Two Doses of SSR149415 in Outpatients With Major Depressive Disorder

This study has been completed.
Sponsor:
Information provided by:
Sanofi
ClinicalTrials.gov Identifier:
NCT00358631
First received: July 31, 2006
Last updated: April 10, 2009
Last verified: April 2009
History of Changes
  Purpose

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 depressive disorder.


Condition Intervention Phase
Depressive Disorder
 Drug: SSR149415
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: An Eight-Week, Multicenter, Double-Blind, Placebo- and Escitalopram-Controlled Study Evaluating the Efficacy and Tolerability of Two Fixed Doses of SSR149415 (250 mg Bid and 100 mg Bid) in Outpatients With Major Depressive Disorder

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Sanofi:

Primary Outcome Measures:
  • 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 Outcome Measures:
  • 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.

Enrollment: 319
Study Start Date: July 2006
Study Completion Date: December 2007
Primary Completion Date: December 2007 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years to 64 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diagnosis of major depressive disorder, as defined by DSM-IV criteria and confirmed by the semi-structured MINI, recurrent episode.

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, 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

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00358631

Locations
United States, New Jersey
Sanofi-Aventis
Bridgewater, New Jersey, United States, 08807
Sponsors and Collaborators
Sanofi
Investigators
Study Director: ICD CSD Sanofi
  More Information

No publications provided by Sanofi

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: ICD Study Director, sanofi-aventis
ClinicalTrials.gov Identifier: NCT00358631     History of Changes
Other Study ID Numbers: DFI5878
Study First Received: July 31, 2006
Last Updated: April 10, 2009
Health Authority: United States: Food and Drug Administration

Keywords provided by Sanofi:
depression
antidepressive agents
controlled clinical trial

Additional relevant MeSH terms:
Depressive Disorder
Depression
Depressive Disorder, Major
Mood Disorders
Mental Disorders
Behavioral Symptoms
 Antidepressive Agents
Psychotropic Drugs
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 22, 2013