Combined Treatment for Generalized Anxiety Disorder (GAD)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2008 by University of Pennsylvania.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
Information provided by:
University of Pennsylvania
ClinicalTrials.gov Identifier:
NCT00620776
First received: February 7, 2008
Last updated: October 28, 2008
Last verified: October 2008
  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 2

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:


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).

Detailed 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.
  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
  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
Disease
Mental Disorders
Pathologic Processes
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 September 29, 2014