An Eight-week Study of Saredutant and Escitalopram as Combination Treatment for Major Depressive Disorder
Primary Purpose
Major Depressive Disorder
Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
saredutant (SR48968)
escitalopram
placebo
Sponsored by
About this trial
This is an interventional treatment trial for Major Depressive Disorder focused on measuring Depression, Major Depressive Episode, Antidepressant
Eligibility Criteria
Inclusion Criteria:
- Outpatients with recurrent Major Depressive Disorder
Exclusion Criteria:
- Symptoms of current depressive episode for less than 30 days or more than 2 years
- Mild depression, as measured by standard clinical research scales
- Significant suicide risk
- Lack of sexual activity (including masturbation)
- Other psychiatric conditions that would obscure the results of the study
- History of failure to respond to antidepressant treatment
- Pregnancy or breast-feeding
The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
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
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Active Comparator
Placebo Comparator
Arm Label
Saredudant/Escitalopram
Placebo and Escitalopram
Placebo
Arm Description
Saredutant 100 mg and Escitalopram 10 mg once daily for a maximum of 8 weeks
Placebo for saredutant and Escitalopram 10 mg once daily for a maximum of 8 weeks
Placebo for saredutant and Placebo for Escitalopram once daily for one week during the screening phase and for a maximum of 8 weeks during the active phase
Outcomes
Primary Outcome Measures
Change from baseline to Day 56 in Hamilton depression rating scale (HAM-D) total score
Change from Baseline to Day 56 in the CGI-S Severity of Illness 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 HAM-D depressed mood item scores.
Percentage of patients demonstrating a treatment response
response is defined as a reduction of at least 50% in HAM-D total score between baseline and any post-baseline assessment
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00531622
Brief Title
An Eight-week Study of Saredutant and Escitalopram as Combination Treatment for Major Depressive Disorder
Official Title
An Eight-week, Double-blind, Placebo-controlled Study to Evaluate the Efficacy, Safety, and Tolerability of Saredutant 100 mg Once Daily in Combination With Escitalopram 10 mg Once Daily in Patients With Major Depressive Disorder
Study Type
Interventional
2. Study Status
Record Verification Date
April 2016
Overall Recruitment Status
Completed
Study Start Date
September 2007 (undefined)
Primary Completion Date
January 2009 (Actual)
Study Completion Date
January 2009 (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 main purpose of this study is to evaluate the efficacy of saredutant 100mg once daily in combination with escitalopram 10mg once daily compared to saredutant placebo in combination with escitalopram 10mg once daily in patients with major depressive disorder. This study also includes a double-placebo group (saredutant placebo in combination with escitalopram placebo).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Major Depressive Disorder
Keywords
Depression, Major Depressive Episode, Antidepressant
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
643 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Saredudant/Escitalopram
Arm Type
Experimental
Arm Description
Saredutant 100 mg and Escitalopram 10 mg once daily for a maximum of 8 weeks
Arm Title
Placebo and Escitalopram
Arm Type
Active Comparator
Arm Description
Placebo for saredutant and Escitalopram 10 mg once daily for a maximum of 8 weeks
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo for saredutant and Placebo for Escitalopram once daily for one week during the screening phase and for a maximum of 8 weeks during the active phase
Intervention Type
Drug
Intervention Name(s)
saredutant (SR48968)
Intervention Description
oral administration, capsules
Intervention Type
Drug
Intervention Name(s)
escitalopram
Intervention Description
oral administration, capsules
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention Description
oral administration, capsules
Primary Outcome Measure Information:
Title
Change from baseline to Day 56 in Hamilton depression rating scale (HAM-D) total score
Time Frame
Baseline, Day 56
Title
Change from Baseline to Day 56 in the CGI-S Severity of Illness score
Time Frame
Baseline, 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
Baseline, Day 56
Title
Change from baseline to Day 56 in HAM-D depressed mood item scores.
Time Frame
Baseline, Day 56
Title
Percentage of patients demonstrating a treatment response
Description
response is defined as a reduction of at least 50% in HAM-D total score between baseline and any post-baseline assessment
Time Frame
Day 56
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Outpatients with recurrent Major Depressive Disorder
Exclusion Criteria:
Symptoms of current depressive episode for less than 30 days or more than 2 years
Mild depression, as measured by standard clinical research scales
Significant suicide risk
Lack of sexual activity (including masturbation)
Other psychiatric conditions that would obscure the results of the study
History of failure to respond to antidepressant treatment
Pregnancy or breast-feeding
The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
ICD
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
Buenos Aires
Country
Argentina
Facility Name
Sanofi-Aventis Administrative Office
City
Helsinki
Country
Finland
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
Bromma
Country
Sweden
12. IPD Sharing Statement
Learn more about this trial
An Eight-week Study of Saredutant and Escitalopram as Combination Treatment for Major Depressive Disorder
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