Back to resultsEfficacy and Safety of SR58611A in Patients With Major Depressive Disorder (ORION)
Primary Purpose
Major Depressive Disorder
Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
SR58611A
Sponsored by
About this trial
This is an interventional treatment trial for Major Depressive Disorder focused on measuring major depressive disorder, depression, major depressive episode, antidepressive agents
Eligibility Criteria
Inclusion Criteria: Main inclusion criteria: 1. Out-patients, 18 year and older. 2. Major Depressive Disorder (MDD) with a recurrentMajor Depressive Episode (MDE) according to DSMIV-TR criteria 3. Duration of current episode is at least of 6 weeksunless severity of symptoms justifies shorter duration. 4. Patients have been treated or hospitalized for aprevious episode, or a previous episode requiredantidepressant treatment(s) at the recommended doselevel for a continuous total duration of at least 2months. Exclusion Criteria: Main exclusion criteria: 1. Patients at immediate risk for suicidal behavior 2. Patients with a MDE with psychotic features, catatonic features, seasonal pattern or postpartum onset 3. The duration of the current depressive episode is greater than 2 years 4. Patients whose current depressive episode is secondary to a general medical condition 5. Patients with a lifetime history of (1) bipolar disorder, (2) psychotic disorder, (3) antisocial personality disorder 6. Patients who have received non-pharmacologic, somatic treatments for psychiatric disease 7. Patients who have initiated, stopped, or changed the frequency or nature of psychotherapy within 3 months prior to screening
Sites / Locations
- Sanofi-Aventis Administrative Office
- Sanofi-Aventis Administrative Office
Outcomes
Primary Outcome Measures
17-item Hamilton Depression Rating Scale (HAM-D) total score
Secondary Outcome Measures
Change from baseline in Clinical Global Impression (CGI) and MADRS Severity of Illness score
Safety assessments
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00252356
Brief Title
Efficacy and Safety of SR58611A in Patients With Major Depressive Disorder
Acronym
ORION
Official Title
An Eight-Week, Double-Blind, Placebo Controlled, Multicenter Study With Escitalopram (10 mg qd) as Positive Control, Evaluating the Efficacy, Safety, Tolerability of a Fixed Dose of SR58611A (350 mg q12) in Outpatients With MDD
Study Type
Interventional
2. Study Status
Record Verification Date
March 2009
Overall Recruitment Status
Completed
Study Start Date
September 2005 (undefined)
Primary Completion Date
January 2007 (Actual)
Study Completion Date
May 2007 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Sanofi
4. Oversight
5. Study Description
Brief Summary
To evaluate the efficacy of a fixed dose of SR58611A(350 mg q12) compared to placebo in patients with MajorDepressive Disorder (MDD) using escitalopram (10 mgqd) as positive control. The study is a multicenter, US and Canadian, randomized, double-blind, 3-parallel-group, placebo- and escitalopram-controlled, Phase III study consisting of four segments (A, B, C and D). Segment A is a 1-week, placebo, single-blind period. Segment B is an 8-week, double-blind period. Segment C is an optional 18-week double-blind extension period. Segment D is a 1-week safety follow-up period after study drug discontinuation or early termination (during Segment B or C).
Detailed Description
To evaluate the efficacy of a fixed dose of SR58611A(350 mg q12) compared to placebo in patients with MajorDepressive Disorder (MDD) using escitalopram (10 mgqd) as positive control. The present study is an 8-week, double-blind, placebo- and escitalopram-controlled, randomized, parallel-group study. A 1-week, placebo, single-blind period precedes the 8-week randomized treatment period and an optional 18-week, double-blind extension period follows the randomized treatment period. A Safety Follow up Visit is scheduled 1 week after the acute and extension period, or early termination. Escitalopram, a selective serotonin reuptake inhibitor (SSRI), an approved treatment for MDD, is chosen as a positive control agent in this study. The dose of 10 mg is within the approved dose range with no need for dose adjustment in elderly patients. This trial is designed to formally compare the efficacy, safety, and tolerability of SR58611A to placebo. Escitalopram is used as a positive control.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Major Depressive Disorder
Keywords
major depressive disorder, depression, major depressive episode, antidepressive agents
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
468 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
SR58611A
Primary Outcome Measure Information:
Title
17-item Hamilton Depression Rating Scale (HAM-D) total score
Secondary Outcome Measure Information:
Title
Change from baseline in Clinical Global Impression (CGI) and MADRS Severity of Illness score
Title
Safety assessments
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Main inclusion criteria:
1. Out-patients, 18 year and older.
2. Major Depressive Disorder (MDD) with a recurrentMajor Depressive Episode (MDE) according to DSMIV-TR criteria
3. Duration of current episode is at least of 6 weeksunless severity of symptoms justifies shorter duration.
4. Patients have been treated or hospitalized for aprevious episode, or a previous episode requiredantidepressant treatment(s) at the recommended doselevel for a continuous total duration of at least 2months.
Exclusion Criteria:
Main exclusion criteria:
1. Patients at immediate risk for suicidal behavior
2. Patients with a MDE with psychotic features, catatonic features, seasonal pattern or postpartum onset
3. The duration of the current depressive episode is greater than 2 years
4. Patients whose current depressive episode is secondary to a general medical condition
5. Patients with a lifetime history of (1) bipolar disorder, (2) psychotic disorder, (3) antisocial personality disorder
6. Patients who have received non-pharmacologic, somatic treatments for psychiatric disease
7. Patients who have initiated, stopped, or changed the frequency or nature of psychotherapy within 3 months prior to screening
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
ICD CSD
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
Laval
Country
Canada
12. IPD Sharing Statement
Links:
URL
http://www.sanofi-aventis.com
Description
Related Info
Learn more about this trial
Efficacy and Safety of SR58611A in Patients With Major Depressive Disorder
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