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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)

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 -