Effectiveness of Long-Term Versus Short-Term Treatment of Generalized Anxiety Disorder With Venlafaxine XR

• Status: Completed
• Trial end date: 2009-09-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Pennsylvania
• Collaborator: National Institute of Mental Health (NIMH)
• Treatments: Norepinephrine; Serotonin; Serotonin and Noradrenaline Reuptake Inhibitors; Venlafaxine Hydrochloride

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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