Ignite Creation Date:
2024-05-05 @ 5:14 PM
Last Modification Date:
2024-10-26 @ 9:29 AM
Study NCT ID:
NCT00411099
Status:
COMPLETED
Last Update Posted:
2020-12-23
First Post:
2006-12-11
Brief Title:
Efficacy Safety and Tolerability of Agomelatine in the Treatment of Major Depressive Disorder
Sponsor:
Novartis
Organization:
Novartis
Study Overview
Official Title:
An 8-week Randomized Double-blind Fixed Dosage Placebo-controlled Parallel-group Multi-center Study of the Efficacy Safety and Tolerability of Agomelatine 25 mg and 50 mg in the Treatment of Major Depressive Disorder MDD Followed by a 52-week Open-label Extension CAGO178A2301E
Status:
COMPLETED
Status Verified Date:
2012-05
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:
This study will assess efficacy safety and tolerability of agomelatine AGO178 25 mg and 50 mg in patients with Major Depressive Disorder MDD This study includes an 8-week double-blind phase and a 52-week open-label phase
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