Combined Treatment for Generalized Anxiety Disorder (GAD)
This trial is active, not recruiting.
|Condition||generalized anxiety disorder|
|Treatments||cognitive behavioral therapy, venlafaxine xr|
|Sponsor||University of Pennsylvania|
|Collaborator||National Institutes of Health (NIH)|
|Start date||September 2006|
|End date||June 2008|
|Trial size||30 participants|
|Trial identifier||NCT00620776, 5 R34 MH 072678-02, 802307|
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.
|Intervention model||parallel assignment|
Hamilton Anxiety Rating Scale
time frame: Data collected as part of protocol 709012 at Months 6, 12, and 24
measures of functioning, depression, and core GAD symptoms
time frame: Data will be collected as part of protocol 709012 at months 6, 12, 18, and 24
Male or female participants at least 18 years old.
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
|Official title||Combined Treatment for Generalized Anxiety Disorder (GAD)|
|Description||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.|
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