Phase 2
N=69
Combined Treatment for Generalized Anxiety Disorder (GAD)
Generalized Anxiety Disorder
Bottom Line
View on ClinicalTrials.gov: NCT00620776 ↗Enrolled (actual)
69
Serious AEs
13.1%
Results posted
Feb 2017
Primary outcome: Primary: Hamilton Anxiety Rating Scale (HAM-A) — 25.9; 23.8; 20.9; 19.4 units on a scale — p=.17
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Cognitive Behavioral Therapy (Behavioral); Venlafaxine XR (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Pennsylvania
- Primary completion
- Mar 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Hamilton Anxiety Rating Scale (HAM-A) |
25.9; 23.8; 20.9; 19.4; 17.3; 14.7 | .17 |
| SECONDARY Hospital Anxiety Depression Scale (HAD)-Anxiety Score |
13.6; 13.0; 11.7; 10.9; 10.9; 8.3 | .54 |
| SECONDARY Hospital Anxiety Depression Scale (HAD)-Depression Score |
9.8; 7.3; 8.5; 6.8; 7.9; 5.3 | .86 |
| SECONDARY Hamilton Rating Scale for Depression (HAM-D)-17-item Score |
13.1; 12.3; 7.0; 3.9; 5.1; 3.0 | .051 |
| SECONDARY Clinical Global Impression (CGI)-Severity Score |
4.7; 4.7; 4.1; 3.9; 3.6; 3.2 | .06 |
| SECONDARY Clinical Global Impression (CGI)-Improvement Score |
2.6; 3.1; 3.3; 3.2; 2.7; 2.4 | .95 |
| SECONDARY Quality of Life Subscale of the General Health Questionnaire (GHQ) |
34.5; 32.2; 24.8; 20.4; 23.8; 22.9 | .17 |
| SECONDARY Penn State Worry Questionnaire (PSWQ) |
61.8; 57.9; 48.6; 42.3; 46.4; 45.1 | .53 |
| SECONDARY Physical Component Score of the 12-Item Short Form Survey (SF-12) |
46.1; 52.7; 46.2; 51.9; 45.5; 49.7 | .23 |
| SECONDARY Mental Component Score of the 12-item Short Form Survey (SF-12) |
28.5; 31.4; 46.2; 48.3; 45.5; 49.8 | .07 |
| SECONDARY Clinical Response Rate |
17; 25 | .63 |
| SECONDARY 50 Percent or Greater Reduction in PSWQ Score |
19; 28 | .52 |
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.
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
Data sourced from ClinicalTrials.gov (NCT00620776). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.