Ignite Creation Date:
2024-05-05 @ 12:09 PM
Last Modification Date:
2024-10-26 @ 9:20 AM
Study NCT ID:
NCT00252356
Status:
COMPLETED
Last Update Posted:
2009-03-12
First Post:
2005-11-10
Brief Title:
Efficacy and Safety of SR58611A in Patients With Major Depressive Disorder
Sponsor:
Sanofi
Organization:
Sanofi
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2009-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ORION
Brief Summary:
To evaluate the efficacy of a fixed dose of SR58611A350 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 SR58611A350 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None