Expired Study
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Philadelphia, Pennsylvania 19104


Purpose:

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.


Study summary:

The specific aims of this study are to collect preliminary data relevant to the following hypotheses: 1. Primary Hypothesis: Acute phase improvement for combined cognitive behavioral therapy (CBT) plus medication will be superior to medication alone. 2. Secondary Hypotheses: Combined CBT plus medication will be superior to medication alone on a number of secondary outcome measures, including the core feature of GAD (worry), depressive symptoms, functional impairment, and quality of life. 3. Additional Exploratory Aim: We will explore the comparative relapse rates for the combined CBT plus medication treatment and the medication alone treatment condition at 6-month follow-up.


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


NCT ID:

NCT00620776


Primary Contact:

N/A


Backup Contact:

N/A


Location Contact:

Philadelphia, Pennsylvania 19104
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: March 16, 2018

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