[en] The anxiolytic activity and tolerance of four doses of suriclone (0.1, 0.2, 0.3 and 0.4 mg tid), diazepam (5 mg tid), and placebo were compared in six parallel groups of 54-59 outpatients with generalized anxiety disorder (DSM III-R). After a 1-week placebo run-in period, the patients were treated for 4 weeks, with assessments at baseline and after 1, 2, and 4 weeks by the Hamilton anxiety scale and the Clinical Global Impressions. Results showed better improvement with active drugs as compared to placebo, without significant differences among the four different doses of suriclone and diazepam. The number of adverse events, particularly drowsiness, was significantly higher with diazepam than with suriclone, particularly 0.1 and 0.2 mg tid which did not differ from placebo. These results demonstrate that suriclone at daily doses ranging from 0.1 to 0.4 mg tid is an effective anxiolytic, better tolerated than diazepam.
Disciplines :
Treatment & clinical psychology
Author, co-author :
Ansseau, Marc ; Université de Liège - ULiège > Département des sciences cliniques > Psychiatrie et psychologie médicale
Olie, J. P.
von Frenckell, Rémy ; Université de Liège - ULiège > Psychiatrie et psychologie médicale
Jourdain, G.
Stehle, B.
Guillet, P.
Language :
English
Title :
Controlled Comparison of the Efficacy and Safety of Four Doses of Suriclone, Diazepam, and Placebo in Generalized Anxiety Disorder
Diagnostical and Statistical manual of mental disorders, American Psychiatric Association, 3rd edn, American Psychiatric Press, Washington DC; 1987.
Ansseau M., von Frenckell R. (1991) Early clinical testing of non-benzodiazepine anxiolytics. New concepts in anxiety , M., Briley, S., File, McMillan, London; 469-480.
Ansseau M., Doumont A., Thiry D., von Frenckell R., Collard J. (1985) Initial study of methylclonazepam in generalized anxiety disorder. Evidence for greater power in the cross-over design. Psychopharmacology 87:130-165.
Basset P., Durand G., Forette B., Jean-Louis P., Lecourt-Bakouche M.C., Lormeau G., Pilate C., Rives H. (1983) Etude en double insu contre placebo d'un nouvel anxiolytique: la suriclone. Thérapie 38:671-677.
Blanchard J.C., Julou L. (1983) Suriclone: a new cyclopyrrolone derivative recognizing receptors labeled by benzodiazepines in rat hippocampus and cerebellum. J Neurochem 40:601-607.
Blanchard J.C., Boireau A., Garret C., Julou L. (1979) In vitro and in vivo inhibition by zopiclone of benzodiazepine binding to rodent brain receptors. Life Sci 24:2417-2420.
Blanchard J.C., Zundel J.L., Julou L. (1983) Differences between cyclopyrrolones (suriclone and zopiclone) and benzodiazepines binding to rat hippocampus photolabelled membranes. Biochem Pharmacol 32:3651-3653.
Blanchard J.C., Piot O., Betschart J., Boireau A., Doble A., Stutzmann J.M. (1990) Chronic cyclopyrrolone treatment does not induce physical dependence in mice. Abstracts of the XVIIth CINP Congress, Kyoto 2:374.
Covi L., Lipman R., McNair D.M., Czerlinski T. (1979) Symptomatic volunteers in multicenter drug trials. Prog Neuropsychopharmacol 3:521-533.
De Jonghe F., Swinkels J., Tuynman-Qua H., Jonkers F. (1989) A comparative study of suriclone, lorazepam and placebo in anxiety disorder. Pharmacopsychiatry 22:266-271.
Falk W.E., Rosenbaum J.F., Sheehan D.V., Claycomb J.B., Clarke J. (1987) Suriclone for generalized anxiety disorder: an escalating multiple-dose, safety, tolerance, and efficacy study. Psychopharmacol Bull 23:134-138.
Gerlach J., Christensen J.K., Rosted Christensen T.L., Elley J., Stigaard Jensen P., Larsen S.B. (1987) Suriclone and diazepam in the treatment of neurotic anxiety. Psychopharmacology 93:296-300.
Gotfryd M.A. (1984) A double-blind compared study of suriclone, lorazepam, and placebo. Clin Neuropharmacol 7:626-627.
ECDEU Assessment manual for psychopharmacology (revised), W., Guy, National Institute of Mental Health, Psychopharmacology Research Branch, Rockville; 1976.
Hakim C. (1984) A controlled dose response study of suriclone in psychiatry patients. Clin Neuropharmacol 7:628-629.
Hamilton M. (1959) The assessment of anxiety states by rating. Br J Med Psychol 32:50-55.
Julou L., Blanchard J.C., Dreyfus J.F. (1985) Pharmacological and clinical studies of cyclopyrrolones: zopiclone and suriclone. Pharmacol Biochem Behav 23:653-659.
Lapierre Y.D., Oyewumi K.L. (1983) Suriclone: a new anxiolytic drug. Prog Neuropsychopharmacol 7:805-807.
Mathieu M. New drug development: a regulatory overview, Parexel, Cambridge (MA); 1990.
Bonnes pratiques cliniques. Avis aux promoteurs et aux investigateurs pour les essais cliniques des médicaments, Ministère des Affaires Sociales et de l'Emploi, Ministère chargé de la Santé et de la Famille, Direction de la Pharmacie et du Médicament (France), Texte officiel en langue française, Paris; 1987.
Ono H., Morishita S., Kasuya M., Kobayashi M., Miyamoto M., Oka J., Goto M., Fukuda H. (1987) Comparison of the effects of the new anxiolytic suriclone and benzodiazepines on motor function and electroencephalogram. Drug Res 37:384-388.
Raskin A., Schulterbrandt J., Reatig N., Rice C.E. (1967) Factors of psychopathology in interview, ward behavior and self-report ratings of hospitalized depressions. J Consult Psychol 31:270-278.
Shaw C.A., Sellers E.M., Sullivan J.T., Kaplan H.L. (1988) Comparative neurologic effects of diazepam and suriclone, a cyclopyrrolone anxiolytic. J Clin Psychopharmacol 8:189-192.
Sullivan J.W., Klein K.L., Anderson C., Smart T., Furman S., Glinka S., Gold L., Inserra J., Sepinvall J. (1984) A pharmacologic comparison of non-benzodiazepine zopiclone, suriclone and tracazolate to the benzodiazepine diazepam. Fed Proc 43:947.
Trifiletti R.R., Snyder S.H. (1984) Anxiolytic cyclopyrrolones zopiclone and suriclone bind to novel site linked allosterically to benzodiazepine receptors. Mol Pharmacol 26:458-469.
Vadrot M., Poggioli J., Guillon Y., Dreyfus J.F. (1986) Détection des effets anxiolytiques de la suriclone sur le stress induit par les interventions dentaires. Thérapie 41:311-313.
Zundel J.L., Blanchard J.C., Julou L. (1985) Partial chemical characterization of cyclopyrrolones (3H suriclone) and benzodiazepines (3H flunitrazepam) binding sites: differences. Life Sci 36:2247-2255.
