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Combination of Paroxetine CR and Quetiapine for the Treatment of Refractory Generalized Anxiety Disorder
The purpose of this study is to examine the safety and efficacy of quetiapine for generalized anxiety disorder patients who remain symptomatic despite treatment with paroxetine CR.
Details
| Lead sponsor | Massachusetts General Hospital |
|---|---|
| Phase | Phase 4 |
| Status | COMPLETED |
| Enrolment | 50 |
| Start date | 2004-02 |
| Completion | 2007-11 |
Conditions
- Anxiety Disorder
Interventions
- Continued Paroxetine CR
- Quetiapine
- Placebo
Primary outcomes
- Hamilton Anxiety Scale (HAM-A) Score at Study Endpoint. — Baseline and Week 18
Symptoms of generalized anxiety disorder as measured by the Hamilton Anxiety Scale (HAM-A) at week 18/study endpoint. Each item is scored on a scale from 0 (not present) to 4 (severe) with a total score range of 0-56. Changes in HAM-A scores are calculated as the difference between the baseline HAM-A scores and scores at week 18/study endpoint. The 14-item Hamilton Anxiety Rating Scale (HAM-A) (Hamilton, 1959) was developed to assess anxiety in a clinical population. It is considered a measure of general anxiety across anxiety disorders, in addition to being a gold standard measure for GAD.
Countries
United States