A 24-52-week Study to Evaluate the Long-term Efficacy and Safety of Saredutant in Patients With Depression (MAGENTA)

Depressive Disorder Clinical Trial

Official title:

A Multicenter, 24-52-week, Double-blind, Placebo-controlled Study to Evaluate the Efficacy, and Safety of Saredutant 100 mg Once Daily in the Prevention of Relapse of Depressive Symptoms in Outpatients With Major Depressive Disorder

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00336713
• Other study ID #: EFC5576
• Secondary ID: SR48968
• Status: Completed
• Phase: Phase 3
• First received: June 13, 2006
• Last updated: July 28, 2011
• Start date: May 2006
• Est. completion date: April 2008

Study information

• Verified date: July 2011
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

The purpose of the study is to evaluate the long-term efficacy and safety of saredutant in patients with depression. The primary objective is to evaluate the efficacy and safety of saredutant 100 mg once daily compared to placebo in the prevention of relapse of depressive symptoms in outpatients with major depressive disorder who achieved an initial response to 12 weeks of open-label treatment with saredutant.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 430
• Est. completion date: April 2008
• Est. primary completion date: April 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Diagnosis of major depressive disorder, as defined by DSM-IV criteria and confirmed by the semi-structured Mini International Neuropsychiatric Interview (MINI), recurrent episode.

Exclusion Criteria:

• Total score of 28 or less on the Montgomery and Asberg Depression Rating Scale (MADRS).

• Clinical Global Impression (CGI) severity score of less than 4.

• Duration of the current depressive episode less than 2 months or greater than 2 years.

• Elderly patients with a Mini-Mental State Examination (MMSE) total score <25.

• 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.

• Benzodiazepine or sedative-hypnotic use greater than 2 days per week during the month prior to entry into the Acute Phase.

• 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 antidepressant 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

Intervention

Drug:
• Saredutant (SR48968C)
oral administration (capsules)
• Placebo
oral administration (capsules)

Locations

Country	Name	City	State
United States	Sanofi-Aventis	Bridgewater	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
Sanofi

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The time to relapse of depressive symptoms (in days) during the Maintenance Phase.		minimum 24 weeks and maximum 52 weeks	No
Secondary	Changes from baseline in the CGI Severity of Illness, MADRS total, and HAM-A total and factor scores during the Maintenance Phase.		minimum 24 weeks and maximum 52 weeks	No