Combined Treatment for Generalized Anxiety Disorder (GAD)

• Status: Completed
• Trial end date: 2008-03-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to conduct a preliminary evaluation of the efficacy of combined medication and psychotherapy for generalized anxiety disorder (GAD). The general goals of the current study are to conduct a late stage treatment development study. The goal of this stage of research is to provide a preliminary answer to the question and to gather data to estimate intervention parameters (e.g., effect size, attrition rates, response rates) that would assist in planning further research.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Pennsylvania
• Collaborators: National Institute of Mental Health (NIMH); National Institutes of Health (NIH)
• Treatments: Venlafaxine Hydrochloride

Criteria

Inclusion Criteria:

• GAD diagnosis by structured interview

• Hamilton Anxiety Scale score of 18 or less

• Clinical Global Impressions 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 s

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 psychotic medication besides benzodiazepines