Status:
COMPLETED
Effectiveness of Long-Term Versus Short-Term Treatment of Generalized Anxiety Disorder With Venlafaxine XR
Lead Sponsor:
University of Pennsylvania
Collaborating Sponsors:
National Institute of Mental Health (NIMH)
Conditions:
Anxiety Disorders
Eligibility:
All Genders
18+ years
Phase:
PHASE4
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 ...
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...
Eligibility Criteria
Inclusion
- GAD diagnosis by structured interview
- Hamilton Anxiety Scale score of 18 or MORE
- Clinical Global Impressions Severity Scale score of at least 4
- Hamilton Depression Scale score of 18 or less
- Hamilton Depression Scale suicide item score less than 2
- Use of an effective form of contraception throughout the study
Exclusion
- Hypersensitivity to venlafaxine XR
- History of seizures
- Episode of major depressive disorder in the previous 6 months
- History of any psychotic illness, bipolar disorder, or dementia
- Substance abuse and dependence during the past 6 months
- Other anxiety disorders with the exception of social phobia as long as GAD is primary
- Regular use of anxiolytics or antidepressants within 7 days of study onset
- Use of fluoxetine or monoamine oxidase inhibitors within 28 days of study onset (low dose usage of benzodiazepines will not prevent participation)
- Use of other psychotropic medication besides benzodiazepines during the study
Key Trial Info
Start Date :
January 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2009
Estimated Enrollment :
268 Patients enrolled
Trial Details
Trial ID
NCT00183274
Start Date
January 1 2004
End Date
September 1 2009
Last Update
January 16 2017
Active Locations (1)
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1
University of Pennsylvania, 3535 Market Street, Suite 670
Philadelphia, Pennsylvania, United States, 19104-3309