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The safety and efficacy of ipsapirone vs. lorazepam in outpatients with generalized anxiety disorder (GAD): single site findings from a multicenter trial.
Psychopharmacol Bull 1993; 29(2):303-8PB

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+Show Affiliations

California Clinical Trials, Beverly Hills 90211.No affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Clinical Trial
Comparative Study
Journal Article
Multicenter Study
Randomized Controlled Trial

Language

eng

PubMed ID

7904761

Citation

Cutler, N R., et al. "The Safety and Efficacy of Ipsapirone Vs. Lorazepam in Outpatients With Generalized Anxiety Disorder (GAD): Single Site Findings From a Multicenter Trial." Psychopharmacology Bulletin, vol. 29, no. 2, 1993, pp. 303-8.
Cutler NR, Sramek JJ, Wardle TS, et al. The safety and efficacy of ipsapirone vs. lorazepam in outpatients with generalized anxiety disorder (GAD): single site findings from a multicenter trial. Psychopharmacol Bull. 1993;29(2):303-8.
Cutler, N. R., Sramek, J. J., Wardle, T. S., Hesselink, J. M., & Roeschen, J. K. (1993). The safety and efficacy of ipsapirone vs. lorazepam in outpatients with generalized anxiety disorder (GAD): single site findings from a multicenter trial. Psychopharmacology Bulletin, 29(2), pp. 303-8.
Cutler NR, et al. The Safety and Efficacy of Ipsapirone Vs. Lorazepam in Outpatients With Generalized Anxiety Disorder (GAD): Single Site Findings From a Multicenter Trial. Psychopharmacol Bull. 1993;29(2):303-8. PubMed PMID: 7904761.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - The safety and efficacy of ipsapirone vs. lorazepam in outpatients with generalized anxiety disorder (GAD): single site findings from a multicenter trial. AU - Cutler,N R, AU - Sramek,J J, AU - Wardle,T S, AU - Hesselink,J M, AU - Roeschen,J K, PY - 1993/1/1/pubmed PY - 1993/1/1/medline PY - 1993/1/1/entrez SP - 303 EP - 8 JF - Psychopharmacology bulletin JO - Psychopharmacol Bull VL - 29 IS - 2 N2 - 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. SN - 0048-5764 UR - https://www.unboundmedicine.com/medline/citation/7904761/The_safety_and_efficacy_of_ipsapirone_vs__lorazepam_in_outpatients_with_generalized_anxiety_disorder__GAD_:_single_site_findings_from_a_multicenter_trial_ L2 - http://www.diseaseinfosearch.org/result/7698 DB - PRIME DP - Unbound Medicine ER -