Combined Treatment for Generalized Anxiety Disorder (GAD)

Generalized Anxiety Disorder Clinical Trial

Official title:

Combined Treatment for Generalized Anxiety Disorder (GAD)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00620776
• Other study ID #: 802307
• Secondary ID: 5R34MH072678-02
• Status: Completed
• Phase: Phase 2
• First received: February 7, 2008
• Last updated: August 15, 2016
• Start date: September 2006
• Est. completion date: April 2010

Study information

• Verified date: August 2016
• Source: University of Pennsylvania
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 19
• Est. completion date: April 2010
• Est. primary completion date: April 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Anxiety Disorders
• Disease
• Generalized Anxiety Disorder

Intervention

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).

Locations

Country	Name	City	State
United States	University of Pennsylvania, 3535 Market Street, Suite 650	Philadelphia	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
University of Pennsylvania	National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hamilton Anxiety Rating Scale		Data collected as part of protocol 709012 at Months 6, 12, and 24	No
Secondary	measures of functioning, depression, and core GAD symptoms		Data will be collected as part of protocol 709012 at months 6, 12, 18, and 24	No