Ignite Creation Date:
2025-12-25 @ 4:02 AM
Ignite Modification Date:
2026-01-09 @ 1:45 AM
Study NCT ID:
NCT00467402
Status:
COMPLETED
Last Update Posted:
2020-12-23
First Post:
2007-04-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy, Safety and Tolerability of Agomelatine in the Prevention of Relapse of Major Depressive Disorder
Sponsor:
Novartis
Organization:
Study Overview
Official Title:
A 52-week, Randomized, Double-blind, Placebo-controlled, Multi-center, Parallel-group Study of the Long-term Efficacy, Tolerability and Safety of Agomelatine 25 and 50 mg in the Prevention of Relapse of Major Depressive Disorder (MDD) Following Open-label Treatment of 16-24 Weeks
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 demonstrate the efficacy of agomelatine (AGO178) 25 mg and 50 mg in the prevention of relapse in patients with Major Depressive Disorder (MDD). Eligible patients will undergo open-label treatment for 20 to 26 weeks, depending on response to treatment. Patients demonstrating stable response at the end of the open-label treatment phase will be assigned to receive agomelatine or placebo for 52 weeks.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?: