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An Eight-week Study Evaluating the Efficacy of a 100mg Dose of Saredutant Once Daily, in Elderly Patients With Major Depressive Disorder

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ClinicalTrials.gov Identifier: NCT00415142
Recruitment Status : Completed
First Posted : December 22, 2006
Last Update Posted : May 24, 2016
Sponsor:
Information provided by (Responsible Party):
Sanofi

Tracking Information
First Submitted Date  ICMJE December 21, 2006
First Posted Date  ICMJE December 22, 2006
Last Update Posted Date May 24, 2016
Study Start Date  ICMJE December 2006
Actual Primary Completion Date February 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 25, 2016)
Change from baseline to Day 56 in the 17-item Hamilton Depression Rating Scale (HAM-D) total score. [ Time Frame: Day 56 ]
Original Primary Outcome Measures  ICMJE
 (submitted: December 21, 2006)
The primary efficacy endpoint is the change from baseline to Day 56 in the 17-item Hamilton Depression Rating Scale (HAM-D) total score.
Change History Complete list of historical versions of study NCT00415142 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: April 25, 2016)
  • Change from baseline to Day 56 in the Clinical Global Impression (CGI) Severity of Illness score. [ Time Frame: Day 56 ]
  • Change from baseline to Day 56 in the HAM-D depressed mood item score [ Time Frame: Day 56 ]
  • Change from baseline to Day 56 in the Montgomery-Asberg Depression Rating Scale (MADRS) total score [ Time Frame: Day 56 ]
Original Secondary Outcome Measures  ICMJE
 (submitted: December 21, 2006)
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.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE An Eight-week Study Evaluating the Efficacy of a 100mg Dose of Saredutant Once Daily, in Elderly Patients With Major Depressive Disorder
Official Title  ICMJE An Eight-week, Multinational, Multicenter, Randomized, Double-blind, Placebo-controlled Study, With Escitalopram as an Active Control, to Evaluate the Efficacy, Safety and Tolerability of a Saredutant 100 mg Dose Once Daily, in Elderly Patients With Major Depressive Disorder
Brief Summary The purpose of the study is to evaluate the efficacy of saredutant in the treatment of Major Depressive Disorder in elderly patients.To evaluate the tolerability, safety and efficacy on disability and quality of life in patients with major depressive disorder.To evaluate safety and tolerability of 24 weeks of additional treatment in patients completing the initial 8-week treatment period.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Depressive Disorder
Intervention  ICMJE
  • Drug: saredutant (SR48968)
    oral administration (capsules)
  • Drug: placebo
    oral administration (capsules)
  • Drug: escitalopram
    oral administration (capsules)
Study Arms  ICMJE
  • Experimental: Saredutant 100 mg
    Saredudant100 mg once daily for a maximum of 32 weeks
    Intervention: Drug: saredutant (SR48968)
  • Active Comparator: Escitalopram 10 mg
    Escitalopram 10 mg once daily for a maximum of 32 weeks
    Intervention: Drug: escitalopram
  • Placebo Comparator: Placebo
    Placebo once daily for one week during screening phase and a maximum of 8 weeks during the acute phase
    Intervention: Drug: placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 8, 2008)
393
Original Enrollment  ICMJE
 (submitted: December 21, 2006)
375
Actual Study Completion Date  ICMJE February 2008
Actual Primary Completion Date February 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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 23 on the MADRS.
  • HAM-D total score less than 17.
  • Duration of the current depressive episode less than 1 month or greater than 2 years.
  • Patients with an Mini Mental State Examination score of less than 23.
  • Patients with a history or presence of bipolar disorders or psychotic disorders.
  • Patients with alcohol/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, monoamine oxidase inhibitors within 4 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

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 60 Years to 64 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Croatia,   Czech Republic,   France,   Mexico,   Russian Federation,   Sweden,   Turkey,   United States
Removed Location Countries Netherlands
 
Administrative Information
NCT Number  ICMJE NCT00415142
Other Study ID Numbers  ICMJE EFC5574
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Sanofi
Study Sponsor  ICMJE Sanofi
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Clinical Sciences & Operations Sanofi
PRS Account Sanofi
Verification Date April 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP