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

Depressive Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00415142
• Other study ID #: EFC5574
• Status: Completed
• Phase: Phase 3
• First received: December 21, 2006
• Last updated: July 25, 2011
• Start date: December 2006
• Est. completion date: February 2008

Study information

• Verified date: July 2011
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationMexico: Ministry of HealthRussia: Ministry of Health of the Russian FederationCroatia: Ministry of Health and Social Care
• Study type: Interventional

Clinical Trial 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 plasma concentrations of saredutant and SR49596 (inactive metabolite).To evaluate safety and tolerability of 24 weeks of additional treatment in patients completing the initial 8-week treatment period.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 393
• Est. completion date: February 2008
• Est. primary completion date: February 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 60 Years to 64 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Depressive Disorder, Major

Intervention

Drug:
• saredutant (SR48968)
oral administration (capsules)
• placebo
oral administration (capsules)
• escitalopram
oral administration (capsules)

Locations

Country	Name	City	State
Croatia	Sanofi-Aventis Administrative Office	Zagreb
Czech Republic	Sanofi-Aventis Administrative Office	Praha
France	Sanofi-Aventis Administrative Office	Paris
Mexico	Sanofi-Aventis Administrative Office	Mexico
Russian Federation	Sanofi-Aventis Administrative Office	Moscow
Sweden	Sanofi-Aventis Administrative Office	Bromma
Turkey	Sanofi-Aventis Administrative Office	Istanbul
United States	Sanofi-Aventis Administrative Office	Bridgewater	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
Sanofi

Countries where clinical trial is conducted

United States,  Croatia,  Czech Republic,  France,  Mexico,  Russian Federation,  Sweden,  Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline to Day 56 in the 17-item Hamilton Depression Rating Scale (HAM-D) total score.		8 weeks	No
Secondary	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.		8 weeks	No