Initial study of methylclonazepam in generalized anxiety disorder - Evidence for greater power in the cross-over design

Anxiety disorders; Benzodiazepines; Lorazepam; Methylclonazepam; Adult; Aged; Benzodiazepinones; Chronic Disease; Clinical Trials; Double-Blind Method; Female; Humans; Male; Middle Aged; Psychiatric Status Rating Scales; Random Allocation; Time Factors

Abstract :

[en] The anxiolytic activity of methylclonazepam was compared to lorazepam and placebo in a double-blind, randomized cross-over study, using a latin square design, in 18 inpatients meeting Research Diagnostic Criteria for Generalized Anxiety Disorders. Patients presented at least 1 year of symptomatology and had a minimum score of 20 on the Hamilton Anxiety Scale, despite chronic anxiolytic pharmacotherapy. Daily dosage was flexible, from three to six tablets of methylclonazepam 1 mg, lorazepam 2.5 mg, or placebo. Clinical evaluation included Hamilton Anxiety Scale, Clinical Global Impression (CGI), a side-effects checklist, completed every 2 days, and the global preference of the patient for one of the treatment periods. Results showed a highly significant superiority of both benzodiazepines over placebo on the Hamilton Scale (P<0.000001) and CGI (P<0.001), and also a significant superiority of methylclonazepam over lorazepam on the Hamilton Scale (P<0.01), CGI-1 (P<0.01), and in the number of patient preferences (14 versus 1; P<0.001), with no significant differences in side-effects or related to position in the trial. These results support the value of the cross-over design in chronic and severe anxious inpatients for the demonstration of differences in efficacy between anxiolytic pharmacotherapies. © 1985 Springer-Verlag.

Disciplines :

Psychiatry

Author, co-author :

ANSSEAU, Marc ; Université de Liège - ULg

Doumont, Adrienne ; Psychopharmacology Unit, University Hospital 'de Bavière', University of Liège Medical School, Liège, B-4020, Belgium

Thiry, Daniel

von Frenckell, Rémy ; Psychopharmacology Unit, University Hospital 'de Bavière', University of Liège Medical School, Liège, B-4020, Belgium

Collard, Jackie

Language :

English

Title :

Initial study of methylclonazepam in generalized anxiety disorder - Evidence for greater power in the cross-over design

Publication date :

1985

Journal title :

Psychopharmacology

ISSN :

0033-3158

eISSN :

1432-2072

Publisher :

Springer, Germany

Volume :

Issue :

Pages :

130-135

Peer reviewed :

Peer Reviewed verified by ORBi

Available on ORBi :

since 01 May 2021

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