Ignite Creation Date:
2024-05-05 @ 11:56 AM
Last Modification Date:
2024-10-26 @ 9:16 AM
Study NCT ID:
NCT00183274
Status:
COMPLETED
Last Update Posted:
2017-01-16
First Post:
2005-09-12
Brief Title:
Effectiveness of Long-Term Versus Short-Term Treatment of Generalized Anxiety Disorder With Venlafaxine XR
Sponsor:
University of Pennsylvania
Organization:
University of Pennsylvania
Study Overview
Official Title:
Short-term Versus Long-term Treatment in Generalized Anxiety Disorder
Status:
COMPLETED
Status Verified Date:
2016-11
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 assess the effectiveness of venlafaxine XR randomized to either venlafaxine XR or placebo in preventing the relapse of generalized anxiety disorder after 6 months of treatment versus 12 months of treatment
Detailed Description:
Generalized anxiety disorder GAD is a highly prevalent chronic psychiatric disorder Despite the fact that GAD frequently demands prolonged treatment with medication very little is known about the benefits of long-term treatment GAD is characterized by 6 months or more of exaggerated worry and tension that is unfounded or much more severe than the normal anxiety most people experience People with GAD are unable to relax and often suffer from insomnia Venlafaxine XR a drug used to treat depression has been shown to be effective in the short-term treatment of GAD However its benefits over a course of more than 8 weeks have not been assessed This study will evaluate the effectiveness of venlafaxine XR in treating GAD on a long-term basis and preventing the relapse of GAD after 6 months of treatment versus 12 months of treatment
Participants in this double-blind study will first receive 6 months of open-label treatment with venlafaxine XR Upon completion of this initial phase participants will be randomly assigned to either continue on venlafaxine XR or begin taking placebo After 12 months participants taking venlafaxine XR will be randomly assigned to continue on the drug or switch to placebo Participants will have 22 study visits over at least 18 months Follow-up visits will occur 24 months after enrollment Relapse of GAD will be assessed with the Hamilton Anxiety Scale and Global Severity and Improvement Scale A variety of methods including questionnaires and standardized scales will be used to assess secondary outcomes
Participants in this double-blind study will first receive 6 months of open-label treatment with venlafaxine XR Upon completion of this initial phase participants will be randomly assigned to either continue on venlafaxine XR or begin taking placebo After 12 months participants taking venlafaxine XR will be randomly assigned to continue on the drug or switch to placebo Participants will have 22 study visits over at least 18 months Follow-up visits will occur 24 months after enrollment Relapse of GAD will be assessed with the Hamilton Anxiety Scale and Global Severity and Improvement Scale A variety of methods including questionnaires and standardized scales will be used to assess secondary outcomes
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| R01MH065963 | NIH | None | httpsreporternihgovquickSearchR01MH065963 |