The safety and efficacy of ipsapirone vs. lorazepam in outpatients with generalized anxiety disorder (GAD): single site findings from a multicenter trial.

Abstract

We report the findings of a randomized, double-blind, placebo-controlled, parallel, generalized anxiety disorder (GAD) outpatient study. The purpose of the study was to compare the efficacy, safety, and tolerability of ipsapirone, an azapirone and 5-HT1A agonist, given at a total daily dose of 10 mg to 30 mg, with a total daily dose of 2 mg to 6 mg of lorazepam or placebo in 90 outpatients with GAD of moderate or greater severity. At baseline, all patients had a Hamilton Anxiety Scale (HAM-A) score of > or = 18 and Covi anxiety score of > or = 8. After a 1-week single-blind washout, patients entered a 4-week double-blind period with an optional extension for another 4 weeks, followed by a 2-week single-blind placebo washout. Ipsapirone and lorazepam ratings on the HAM-A and Clinical Global Impressions (CGI) were significantly (p < .05) superior to placebo at the end of the acute and maintenance periods of the trial, with a 50 percent HAM-A reduction on active drugs vs. 20 percent on placebo. The anxiety of patients receiving lorazepam, but not ipsapirone, rebounded during the final placebo washout.

• Authors: N R Cutler, J J Sramek, T S Wardle, J M Hesselink, J K Roeschen
• Journal: Psychopharmacology bulletin (Psychopharmacol Bull) Vol. 29 Issue 2 Pg. 303-8 ( 1993) ISSN: 0048-5764 [Print] United States
• PMID: 7904761 (Publication Type: Clinical Trial, Comparative Study, Journal Article, Multicenter Study, Randomized Controlled Trial)

Chemical References

• Anti-Anxiety Agents
• Pyrimidines
• ipsapirone
• Lorazepam

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
• Psychiatric Status Rating Scales
• Pyrimidines (adverse effects, therapeutic use)