Abstract |
This multicenter, double-blind, placebo-controlled, randomized study compared the efficacy, safety, and tolerability of ipsapirone (an azapirone anxiolytic) at daily dose levels of 10.0 to 30.0 mg with a daily dose of 2.0 to 6.0 mg of lorazepam (a benzodiazepine) or placebo when given to outpatients with generalized anxiety disorder (GAD) of moderate or greater severity. A total of 317 outpatients with a primary diagnosis of GAD according to DSM-III criteria (at least 1 month's duration) were randomized. Study entry criteria at the time of screening and at baseline included a Hamilton Rating Scale for Anxiety (HAM-A) score of 18 or more, a Covi Anxiety Scale score of 8 or more, and a Raskin Depression Scale score of 7 or less. The study design consisted of a 1-week, single-blind placebo evaluation, a 4-week, double-blind acute treatment period, and a 4-week extension period, followed by a 2-week, single-blind placebo withdrawal period. Efficacy was measured by changes in the HAM-A and Clinical Global Impression Scale and by evaluations of the Hamilton Rating Scale for Depression and Zung-Anxiety Self-Rating scale. The Raskin and Covi scales were performed at screening and baseline only. Withdrawal reactions were assessed during the withdrawal period by the Physician Withdrawal Checklist and by a patient self-rating checklist. Two-hundred sixty-three patients were valid for the analysis of efficacy in the ipsapirone (N = 87), lorazepam (N = 89), and placebo (N = 87) groups.(ABSTRACT TRUNCATED AT 250 WORDS)
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Authors | N R Cutler, J J Sramek, J M Keppel Hesselink, A Krol, J Roeschen, K Rickels, E Schweizer |
Journal | Journal of clinical psychopharmacology
(J Clin Psychopharmacol)
Vol. 13
Issue 6
Pg. 429-37
(Dec 1993)
ISSN: 0271-0749 [Print] United States |
PMID | 7907097
(Publication Type: Clinical Trial, Comparative Study, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
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Chemical References |
- Anti-Anxiety Agents
- Pyrimidines
- ipsapirone
- Lorazepam
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Topics |
- Adult
- Anti-Anxiety Agents
(adverse effects, therapeutic use)
- Anxiety Disorders
(drug therapy, psychology)
- Double-Blind Method
- Female
- Humans
- Lorazepam
(adverse effects, therapeutic use)
- Male
- Prospective Studies
- Psychiatric Status Rating Scales
- Pyrimidines
(adverse effects, therapeutic use)
- Substance Withdrawal Syndrome
(psychology)
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