Clinical trial NCT00620776: Combined Treatment for Generalized Anxiety Disorder (GAD)
Official title: Combined Treatment for Generalized Anxiety Disorder (GAD)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Generalized Anxiety Disorder
Keywords: Generalized Anxiety Disorder
Cognitive Behavioral Therapy
Psychotherapy plus medication
Combined treatment
Lead sponsor: University of Pennsylvania
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2008-02-21
Enrollment: 69
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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 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

Primary outcomes:
measure: Hamilton Anxiety Rating Scale (HAM-A)
timeFrame: Data collected as part of protocol 709012 at baseline, week 2, 4, 6, 8, 12, 16, 20, and 24
Secondary outcomes:
measure: Hospital Anxiety Depression Scale (HAD)-Anxiety Score
timeFrame: Data collected as part of protocol 709012 at baseline, week 2, 4, 6, 8, 12, 16, 20, and 24
measure: Hospital Anxiety Depression Scale (HAD)-Depression Score
timeFrame: Data collected as part of protocol 709012 at baseline, week 2, 4, 6, 8, 12, 16, 20, and 24
measure: Hamilton Rating Scale for Depression (HAM-D)-17-item Score
timeFrame: Data collected as part of protocol 709012 at baseline, week 12, and week 24
measure: Clinical Global Impression (CGI)-Severity Score
timeFrame: Data collected as part of protocol 709012 at baseline, week 2, 4, 6, 8, 12, 16, 20, and 24
measure: Clinical Global Impression (CGI)-Improvement Score
timeFrame: Data collected as part of protocol 709012 at baseline, week 2, 4, 6, 8, 12, 16, 20, and 24
measure: Quality of Life Subscale of the General Health Questionnaire (GHQ)
timeFrame: Data collected as part of protocol 709012 at baseline, week 12, and week 24
measure: Penn State Worry Questionnaire (PSWQ)
timeFrame: Data collected as part of protocol 709012 at baseline, week 12, and week 24
measure: Physical Component Score of the 12-Item Short Form Survey (SF-12)
timeFrame: Data collected as part of protocol 709012 at baseline, week 12, and week 24
measure: Mental Component Score of the 12-item Short Form Survey (SF-12)
timeFrame: Data collected as part of protocol 709012 at baseline, week 12, and week 24
measure: Clinical Response Rate
timeFrame: Data collected as part of protocol 709012 at baseline, week 2, 4, 6, 8, 12, 16, 20, and 24
measure: 50 Percent or Greater Reduction in PSWQ Score
timeFrame: Data collected as part of protocol 709012 at baseline, week 12, and week 24
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: University of Pennsylvania, 3535 Market Street, Suite 650
state: Pennsylvania
Study officials:
affiliation: University of Pennsylvania
name: Paul Crits-Christoph, PhD
role: PRINCIPAL_INVESTIGATOR
References: