Ignite Creation Date:
2024-05-05 @ 5:29 PM
Last Modification Date:
2024-10-26 @ 9:32 AM
Study NCT ID:
NCT00463242
Status:
COMPLETED
Last Update Posted:
2020-12-23
First Post:
2007-04-19
Brief Title:
A Placebo- and Paroxetine-controlled Study of the Efficacy Safety and Tolerability of Agomelatine 25 or 50 mg in the Treatment of Major Depressive Disorder MDD
Sponsor:
Novartis
Organization:
Novartis
Study Overview
Official Title:
An 8-week Multicenter Randomized Double-blind Placebo- and Paroxetine-controlled Study of the Efficacy Safety and Tolerability of Agomelatine 25 or 50 mg Given Once Daily in the Treatment of Major Depressive Disorder MDD Followed by a 52-week Open-label Treatment With Agomelatine 25 or 50 mg
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 evaluate the efficacy safety and tolerability of agomelatine 25 mg or 50 mg per day and will compare agomelatine and paroxetine tolerability Eligible patients will receive double-blind study medication for 8 weeks One week after completion of the double-blind treatment phase there will be a single follow-up visit
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