Combined Treatment for Generalized Anxiety Disorder (GAD) - Full Text View

Sponsor:	University of Pennsylvania
Collaborator:	National Institutes of Health (NIH)
Information provided by:	University of Pennsylvania
ClinicalTrials.gov Identifier:	NCT00620776

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.

Condition	Intervention	Phase
Generalized Anxiety Disorder	Behavioral: Cognitive Behavioral Therapy Drug: Venlafaxine XR	Phase II

Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Combined Treatment for Generalized Anxiety Disorder (GAD)

Resource links provided by NLM:

MedlinePlus related topics: Anxiety

Drug Information available for: Venlafaxine Venlafaxine hydrochloride

U.S. FDA Resources

Further study details as provided by University of Pennsylvania:

Primary Outcome Measures:

Hamilton Anxiety Rating Scale [ Time Frame: Data collected as part of protocol 709012 at Months 6, 12, and 24 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

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 ] [ Designated as safety issue: No ]

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
Experimental: Combined Treatment Patients who receive combined cognitive behavioral therapy (CBT) plus medication treatment for GAD	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).
Active Comparator: Medication alone These patients receive only medication treatment for GAD. Patients take venlafaxine as part of protocol 709012 and are assessed over a 6 month period.	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).

Arms

Assigned Interventions

Experimental: Combined Treatment

Patients who receive combined cognitive behavioral therapy (CBT) plus medication treatment for GAD

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).

Active Comparator: Medication alone

These patients receive only medication treatment for GAD. Patients take venlafaxine as part of protocol 709012 and are assessed over a 6 month period.

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).

Detailed Description:

The specific aims of this study are to collect preliminary data relevant to the following hypotheses:

Primary Hypothesis: Acute phase improvement for combined cognitive behavioral therapy (CBT) plus medication will be superior to medication alone.
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.
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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00620776

Locations

United States, Pennsylvania
University of Pennsylvania, 3535 Market Street, Suite 650
Philadelphia, Pennsylvania, United States, 19104

Sponsors and Collaborators

University of Pennsylvania

National Institutes of Health (NIH)

More Information

No publications provided

Responsible Party:	Paul Crits-Christoph, PhD, University of Pennsylvania
ClinicalTrials.gov Identifier:	NCT00620776 History of Changes
Other Study ID Numbers:	802307, 5 R34 MH 072678-02
Study First Received:	February 7, 2008
Last Updated:	October 28, 2008
Health Authority:	United States: Federal Government

Keywords provided by University of Pennsylvania:

Generalized Anxiety Disorder
Cognitive Behavioral Therapy
Psychotherapy plus medication
Combined treatment

Additional relevant MeSH terms:

Anxiety Disorders
Mental Disorders
Venlafaxine
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions

Serotonin Agents
Physiological Effects of Drugs
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on February 12, 2012