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Sponsors and Collaborators: |
University of Pennsylvania National Institutes of Health (NIH) |
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Information provided by: | University of Pennsylvania |
ClinicalTrials.gov Identifier: | NCT00620776 |
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.
Condition | Intervention | Phase |
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Generalized Anxiety Disorder |
Behavioral: Cognitive Behavioral Therapy Drug: Venlafaxine XR |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Parallel Assignment |
Official Title: | Combined Treatment for Generalized Anxiety Disorder (GAD) |
Estimated Enrollment: | 30 |
Study Start Date: | September 2006 |
Estimated Study Completion Date: | June 2008 |
Estimated Primary Completion Date: | June 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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Combined Treatment: Experimental
Patients who receive combined cognitive behavioral therapy (CBT) plus medication treatment for GAD
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Behavioral: Cognitive Behavioral Therapy
This cognitive behavioral therapy for GAD has a cognitive restructuring component and an applied relaxation component. Patients will be educated about the nature of anxiety and be trained in the recognition and monitoring of situational, physiological, cognitive, and behavioral cues associated with anxious responding. They will be guided through copings skill rehearsals in addition to imaginal and in vivo exposure to anxiety cues. This cognitive behavioral treatment will consist of 1 to 1.5 hour sessions of psychotherapy, which will be held once weekly over a period of 12 weeks.
Drug: Venlafaxine XR
Venlafaxine XR, 75-225 mg/d, oral administration. 14 days at 75 mg/d, 150 mg/d for the remaining 6 months, 225 mg/3 for patients unimproved at week 6, tapered at 75 mg/week (this intervention is provided by protocol 709012).
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Medication alone: Active Comparator
These patients receive only medication treatment for GAD. Patients take venlafaxine as part of protocol 709012 and are assessed over a 6 month period.
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Drug: Venlafaxine XR
Venlafaxine XR, 75-225 mg/d, oral administration. 14 days at 75 mg/d, 150 mg/d for the remaining 6 months, 225 mg/3 for patients unimproved at week 6, tapered at 75 mg/week (this intervention is provided by protocol 709012).
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The specific aims of this study are to collect preliminary data relevant to the following hypotheses:
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Responsible Party: | University of Pennsylvania ( Paul Crits-Christoph, PhD ) |
Study ID Numbers: | 802307, 5 R34 MH 072678-02 |
Study First Received: | February 7, 2008 |
Last Updated: | October 28, 2008 |
ClinicalTrials.gov Identifier: | NCT00620776 |
Health Authority: | United States: Federal Government |
Generalized Anxiety Disorder Cognitive Behavioral Therapy Psychotherapy plus medication Combined treatment |
Anxiety Disorders Mental Disorders Venlafaxine Serotonin |
Neurotransmitter Uptake Inhibitors Neurotransmitter Agents Disease Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Psychotropic Drugs Serotonin Uptake Inhibitors |
Pharmacologic Actions Pathologic Processes Serotonin Agents Therapeutic Uses Antidepressive Agents, Second-Generation Central Nervous System Agents Antidepressive Agents |