Ignite Creation Date:
2024-05-05 @ 11:33 AM
Last Modification Date:
2024-10-26 @ 9:09 AM
Study NCT ID:
NCT00075257
Status:
COMPLETED
Last Update Posted:
2009-08-19
First Post:
2004-01-07
Brief Title:
Study Evaluating DVS-233 SR In Adult Outpatients With Major Depressive Disorder
Sponsor:
Wyeth is now a wholly owned subsidiary of Pfizer
Organization:
Wyeth is now a wholly owned subsidiary of Pfizer
Study Overview
Official Title:
A Multicenter Randomized Double-Blind Placebo-Controlled Parallel Group Study To Evaluate The Efficacy And Safety Of DVS-233 SR For Prevention Of Depressive Relapse In Adult Outpatients With Major Depressive Disorder
Status:
COMPLETED
Status Verified Date:
2009-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Primary Objective To compare the efficacy and safety of DVS-233 SR versus placebo treatment in reducing the relapse rate of depressive symptoms in subjects with major depressive disorder MDD and to compare the percentages of relapse in terms of time to relapse between DVS-233 SR and placebo treatment groups by using survival analysis
Secondary Objective To assess the response of subjects on DVS-233 SR versus placebo for the clinical global evaluation functionality general well-being pain and absence of symptoms Hamilton Psychiatric Rating Scale for Depression 17-item HAM-D17 7
Secondary Objective To assess the response of subjects on DVS-233 SR versus placebo for the clinical global evaluation functionality general well-being pain and absence of symptoms Hamilton Psychiatric Rating Scale for Depression 17-item HAM-D17 7
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