Ignite Creation Date:
2024-05-05 @ 12:02 PM
Last Modification Date:
2024-10-26 @ 9:18 AM
Study NCT ID:
NCT00215176
Status:
COMPLETED
Last Update Posted:
2013-06-19
First Post:
2005-09-20
Brief Title:
Modafinil for Atypical Depression
Sponsor:
Duke University
Organization:
Duke University
Study Overview
Official Title:
A Study of Modafinil for Atypical Depression
Status:
COMPLETED
Status Verified Date:
2005-09
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 purposes of the study are to 1 evaluate the short-term efficacy and safety of modafinil in atypical depression and 2 to evaluate the efficacy of modafinil in preventing relapse of atypical depression The hypothesis is that modafinil is safe and effective in the treatment of atypical depression
Detailed Description:
This study on the safety and efficacy of modafinil on atypical depression has an initial 12-week open label treatment period with modafinil that is followed by a 12-week double-blind randomized parallel treatment period with either modafinil or matching placebo Patients who demonstrate at least minimal improvement after 12 weeks are randomly assigned to either continuing treatment at their current dose or switched to matching placebo for 12 weeks
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