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

Primary Purpose

Depressive Disorder

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Saredutant (SR48968C)
Placebo
Sponsored by
Sanofi
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Depressive Disorder focused on measuring depression, antidepressive agents, controlled clinical trial

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Diagnosis of major depressive disorder, as defined by Diagnostic and Statistical Manual of Mental Disorders 4th edition (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, Monoamine oxidase inhibitors (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.

Sites / Locations

  • Sanofi-Aventis

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Saredutant 100 mg

Placebo

Arm Description

Saredutant 100 mg once daily in the morning for a maximum of 64 weeks

Placebo for Saredutant once daily in the morning during the maintenance phase for a maximum of 52 weeks

Outcomes

Primary Outcome Measures

The time to relapse of depressive symptoms (in days) during the Maintenance Phase.

Secondary Outcome Measures

Changes from baseline in the CGI Severity of Illness, Montgomery-Asberg Depression Rating Scale (MADRS) total, and Hamilton Anxiety Rating Scale (HAM-A) total and factor scores during the Maintenance Phase.

Full Information

First Posted
June 13, 2006
Last Updated
April 13, 2016
Sponsor
Sanofi
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1. Study Identification

Unique Protocol Identification Number
NCT00336713
Brief Title
A 24-52-week Study to Evaluate the Long-term Efficacy and Safety of Saredutant in Patients With Depression (MAGENTA)
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
Study Type
Interventional

2. Study Status

Record Verification Date
April 2016
Overall Recruitment Status
Completed
Study Start Date
May 2006 (undefined)
Primary Completion Date
April 2008 (Actual)
Study Completion Date
April 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sanofi

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depressive Disorder
Keywords
depression, antidepressive agents, controlled clinical trial

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
430 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Saredutant 100 mg
Arm Type
Experimental
Arm Description
Saredutant 100 mg once daily in the morning for a maximum of 64 weeks
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo for Saredutant once daily in the morning during the maintenance phase for a maximum of 52 weeks
Intervention Type
Drug
Intervention Name(s)
Saredutant (SR48968C)
Intervention Description
oral administration (capsules)
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
oral administration (capsules)
Primary Outcome Measure Information:
Title
The time to relapse of depressive symptoms (in days) during the Maintenance Phase.
Time Frame
minimum 24 weeks and maximum 52 weeks
Secondary Outcome Measure Information:
Title
Changes from baseline in the CGI Severity of Illness, Montgomery-Asberg Depression Rating Scale (MADRS) total, and Hamilton Anxiety Rating Scale (HAM-A) total and factor scores during the Maintenance Phase.
Time Frame
minimum 24 weeks and maximum 52 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Diagnosis of major depressive disorder, as defined by Diagnostic and Statistical Manual of Mental Disorders 4th edition (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, Monoamine oxidase inhibitors (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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Sciences & Operations
Organizational Affiliation
Sanofi
Official's Role
Study Director
Facility Information:
Facility Name
Sanofi-Aventis
City
Bridgewater
State/Province
New Jersey
ZIP/Postal Code
08807
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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