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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

Primary Purpose

Depressive Disorder

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
saredutant (SR48968)
placebo
escitalopram
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, Major depressive disorders, Controlled clinical trial

Eligibility Criteria

60 Years - 64 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Sanofi-Aventis Administrative Office
  • Sanofi-Aventis Administrative Office
  • Sanofi-Aventis Administrative Office
  • Sanofi-Aventis Administrative Office
  • Sanofi-Aventis Administrative Office
  • Sanofi-Aventis Administrative Office
  • Sanofi-Aventis Administrative Office
  • Sanofi-Aventis Administrative Office

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Placebo Comparator

Arm Label

Saredutant 100 mg

Escitalopram 10 mg

Placebo

Arm Description

Saredudant100 mg once daily for a maximum of 32 weeks

Escitalopram 10 mg once daily for a maximum of 32 weeks

Placebo once daily for one week during screening phase and a maximum of 8 weeks during the acute phase

Outcomes

Primary Outcome Measures

Change from baseline to Day 56 in the 17-item Hamilton Depression Rating Scale (HAM-D) total score.

Secondary Outcome Measures

Change from baseline to Day 56 in the Clinical Global Impression (CGI) Severity of Illness score.
Change from baseline to Day 56 in the HAM-D depressed mood item score
Change from baseline to Day 56 in the Montgomery-Asberg Depression Rating Scale (MADRS) total score

Full Information

First Posted
December 21, 2006
Last Updated
April 25, 2016
Sponsor
Sanofi
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1. Study Identification

Unique Protocol Identification Number
NCT00415142
Brief Title
An Eight-week Study Evaluating the Efficacy of a 100mg Dose of Saredutant Once Daily, in Elderly Patients With Major Depressive Disorder
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
Study Type
Interventional

2. Study Status

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depressive Disorder
Keywords
Depression, Major depressive disorders, Controlled clinical trial

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
Saredutant 100 mg
Arm Type
Experimental
Arm Description
Saredudant100 mg once daily for a maximum of 32 weeks
Arm Title
Escitalopram 10 mg
Arm Type
Active Comparator
Arm Description
Escitalopram 10 mg once daily for a maximum of 32 weeks
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo once daily for one week during screening phase and a maximum of 8 weeks during the acute phase
Intervention Type
Drug
Intervention Name(s)
saredutant (SR48968)
Intervention Description
oral administration (capsules)
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention Description
oral administration (capsules)
Intervention Type
Drug
Intervention Name(s)
escitalopram
Intervention Description
oral administration (capsules)
Primary Outcome Measure Information:
Title
Change from baseline to Day 56 in the 17-item Hamilton Depression Rating Scale (HAM-D) total score.
Time Frame
Day 56
Secondary Outcome Measure Information:
Title
Change from baseline to Day 56 in the Clinical Global Impression (CGI) Severity of Illness score.
Time Frame
Day 56
Title
Change from baseline to Day 56 in the HAM-D depressed mood item score
Time Frame
Day 56
Title
Change from baseline to Day 56 in the Montgomery-Asberg Depression Rating Scale (MADRS) total score
Time Frame
Day 56

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
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 Administrative Office
City
Bridgewater
State/Province
New Jersey
ZIP/Postal Code
08807
Country
United States
Facility Name
Sanofi-Aventis Administrative Office
City
Zagreb
Country
Croatia
Facility Name
Sanofi-Aventis Administrative Office
City
Praha
Country
Czech Republic
Facility Name
Sanofi-Aventis Administrative Office
City
Paris
Country
France
Facility Name
Sanofi-Aventis Administrative Office
City
Mexico
Country
Mexico
Facility Name
Sanofi-Aventis Administrative Office
City
Moscow
Country
Russian Federation
Facility Name
Sanofi-Aventis Administrative Office
City
Bromma
Country
Sweden
Facility Name
Sanofi-Aventis Administrative Office
City
Istanbul
Country
Turkey

12. IPD Sharing Statement

Learn more about this trial

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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