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A double-blind, placebo-controlled study comparing the efficacy and safety of ipsapirone versus lorazepam in patients with generalized anxiety disorder: a prospective multicenter trial.
J Clin Psychopharmacol 1993; 13(6):429-37JC

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)

Authors+Show Affiliations

Miles Inc., West Haven, Connecticut.No affiliation info availableNo affiliation info availableNo 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
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

7907097

Citation

Cutler, N R., et al. "A Double-blind, Placebo-controlled Study Comparing the Efficacy and Safety of Ipsapirone Versus Lorazepam in Patients With Generalized Anxiety Disorder: a Prospective Multicenter Trial." Journal of Clinical Psychopharmacology, vol. 13, no. 6, 1993, pp. 429-37.
Cutler NR, Sramek JJ, Keppel Hesselink JM, et al. A double-blind, placebo-controlled study comparing the efficacy and safety of ipsapirone versus lorazepam in patients with generalized anxiety disorder: a prospective multicenter trial. J Clin Psychopharmacol. 1993;13(6):429-37.
Cutler, N. R., Sramek, J. J., Keppel Hesselink, J. M., Krol, A., Roeschen, J., Rickels, K., & Schweizer, E. (1993). A double-blind, placebo-controlled study comparing the efficacy and safety of ipsapirone versus lorazepam in patients with generalized anxiety disorder: a prospective multicenter trial. Journal of Clinical Psychopharmacology, 13(6), pp. 429-37.
Cutler NR, et al. A Double-blind, Placebo-controlled Study Comparing the Efficacy and Safety of Ipsapirone Versus Lorazepam in Patients With Generalized Anxiety Disorder: a Prospective Multicenter Trial. J Clin Psychopharmacol. 1993;13(6):429-37. PubMed PMID: 7907097.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - A double-blind, placebo-controlled study comparing the efficacy and safety of ipsapirone versus lorazepam in patients with generalized anxiety disorder: a prospective multicenter trial. AU - Cutler,N R, AU - Sramek,J J, AU - Keppel Hesselink,J M, AU - Krol,A, AU - Roeschen,J, AU - Rickels,K, AU - Schweizer,E, PY - 1993/12/1/pubmed PY - 1993/12/1/medline PY - 1993/12/1/entrez SP - 429 EP - 37 JF - Journal of clinical psychopharmacology JO - J Clin Psychopharmacol VL - 13 IS - 6 N2 - 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) SN - 0271-0749 UR - https://www.unboundmedicine.com/medline/citation/7907097/A_double_blind_placebo_controlled_study_comparing_the_efficacy_and_safety_of_ipsapirone_versus_lorazepam_in_patients_with_generalized_anxiety_disorder:_a_prospective_multicenter_trial_ L2 - http://ovidsp.ovid.com/ovidweb.cgi?T=JS&PAGE=linkout&SEARCH=7907097.ui DB - PRIME DP - Unbound Medicine ER -