Phase 2
Completed N=69
Combined Treatment for Generalized Anxiety Disorder (GAD)
Source: ClinicalTrials.gov NCT00620776 ↗Enrolled (actual)
69
Serious AEs
13.1%
Results posted
Feb 2017
Primary outcomePrimary: Hamilton Anxiety Rating Scale (HAM-A) — 25.9; 23.8; 20.9; 19.4 units on a scale — p=.17
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.
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 |
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. Informational only — not medical advice.