Ignite Creation Date:
2024-05-05 @ 12:07 PM
Last Modification Date:
2024-10-26 @ 9:20 AM
Study NCT ID:
NCT00250601
Status:
COMPLETED
Last Update Posted:
2012-02-17
First Post:
2005-10-18
Brief Title:
An Eight-week Study to Evaluate the Efficacy and Safety of Saredutant in Patients With Depression
Sponsor:
Sanofi
Organization:
Sanofi
Study Overview
Official Title:
An Eight-Week Multicenter Double-blind Placebo-controlled Study Evaluating the Efficacy Safety and Tolerability of One Fixed 100 mg Dose of Saredutant in Patients With Major Depressive Disorder
Status:
COMPLETED
Status Verified Date:
2012-02
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:
The purpose of the study is to evaluate the efficacy and safety of saredutant or SR48968C in patients with depression
The primary objective is to evaluate the efficacy of a 100 mg dose of saredutant compared to placebo in patients with depression
The secondary objectives are to evaluate the safety of saredutant to evaluate the efficacy of saredutant on disability and quality of life in patients with depression and to evaluate blood levels of saredutant
The primary objective is to evaluate the efficacy of a 100 mg dose of saredutant compared to placebo in patients with depression
The secondary objectives are to evaluate the safety of saredutant to evaluate the efficacy of saredutant on disability and quality of life in patients with depression and to evaluate blood levels of saredutant
Detailed Description:
The study is a multicenter US randomized parallel-group double blind placebo and paroxetine-controlled study consisting of three segments A B and C Segment A is a 1-week placebo single-blind period and Segment B is an 8-week double blind period Patients completing Segment B may be eligible for enrollment into Segment C a 44-week double blind extension All randomized patients must complete a post-study telephone visit and a post-study office visit 3 days and 1 week respectively after intake of the last dose of study medication
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| Saredutant SR48968C | None | None | None |