Ignite Creation Date:
2024-05-05 @ 5:05 PM
Last Modification Date:
2024-10-26 @ 9:28 AM
Study NCT ID:
NCT00385307
Status:
COMPLETED
Last Update Posted:
2009-03-25
First Post:
2006-10-06
Brief Title:
Efficacy and Safety of SR58611A in Patients With Major Depressive Disorder SIRIUS
Sponsor:
Sanofi
Organization:
Sanofi
Study Overview
Official Title:
An Eight-Week Double-Blind Placebo-Controlled Multicenter Study With Paroxetine 10 mg qd as Positive Control Evaluating the Efficacy Safety Tolerability of Two Fixed Doses of SR58611A 175 mg q12 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:
None
Brief Summary:
To evaluate the efficacy of two fixed doses of SR58611A 175 mg q12 and 350 mg q12 compared to placebo in patients with Major Depressive Disorder MDD using paroxetine 20 mg qd as positive control In addition the tolerability and safety of SR58611A in patients with MDD will be evaluated
Detailed Description:
None
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