Ignite Creation Date:
2024-05-05 @ 11:43 AM
Last Modification Date:
2024-10-26 @ 9:12 AM
Study NCT ID:
NCT00114127
Status:
COMPLETED
Last Update Posted:
2014-06-10
First Post:
2005-06-13
Brief Title:
Duloxetine for Social Anxiety Disorder Prediction of Long Term Outcome
Sponsor:
Massachusetts General Hospital
Organization:
Massachusetts General Hospital
Study Overview
Official Title:
Duloxetine for Social Anxiety Disorder Prediction of Long Term Outcome
Status:
COMPLETED
Status Verified Date:
2014-06
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 purpose of this study is to examine the safety and efficacy of duloxetine for the treatment of social anxiety disorder
Detailed Description:
An expanding body of clinical experience and controlled trials has established the efficacy of serotonin selective reuptake inhibitors SSRIs and the serotonin norepinephrine reuptake inhibitor SNRI venlafaxine for the treatment of social anxiety disorder with paroxetine sertraline and venlafaxine extended-release XR which are FDA approved for this indication The newest SNRI duloxetine has been shown to be effective at doses of 60mgday to 120mgday for anxiety associated with depression and is anticipated to be a broad spectrum agent for mood and anxiety disorders Dunner Goldstein Mallinckrodt Lu Detke 2003 However no data on the efficacy of duloxetine for Social Anxiety Disorder nor guidance regarding time to response or predictors of response is yet available These questions are the focus of this proposal
This is a two phase 24-week research study in which participants who remain symptomatic at the end of one phase 6 weeks enter into the next phase In phase I all participants receive 60mgday of duloxetine Cymbalta for 6 weeks Participants who continue to have anxiety symptoms will enter the 18-week Phase II in which they continue taking 60 mgday of duloxetine and they will also be randomly assigned by chance like a flip of a coin to receive either an additional 60mgday of duloxetine or placebo contains no active medication
This is a two phase 24-week research study in which participants who remain symptomatic at the end of one phase 6 weeks enter into the next phase In phase I all participants receive 60mgday of duloxetine Cymbalta for 6 weeks Participants who continue to have anxiety symptoms will enter the 18-week Phase II in which they continue taking 60 mgday of duloxetine and they will also be randomly assigned by chance like a flip of a coin to receive either an additional 60mgday of duloxetine or placebo contains no active medication
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