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Pilot clinical investigation of risperidone in the treatment of psychotic patients. 1990

Y G Gelders, and S L Heylen, and G Vanden Bussche, and A J Reyntjens, and P A Janssen
Department of Clinical Research and Development, Janssen Research Foundation, Beerse, Belgium.

Sixty-one adult psychotic patients were treated for four weeks in an open dose-finding study with the new combined serotonin-dopamine antagonist risperidone (R 64 766). Risperidone had a rapid onset of action; a highly significant decrease in the total score on the Brief Psychiatric Rating Scale (BPRS) was already noticed after the first week of treatment. There was also a significant decrease in score for individual BPRS items related to positive, negative, and affective symptoms. In spite of the withdrawal of antiparkinson medication at selection, a significant decrease in extra-pyramidal symptoms (EPS) was observed, as assessed on the Simpson and Angus Scale. The Clinical Global Impression of therapeutic effect was consistent with the BPRS scores, showing a constant improvement throughout the study. The mean daily dose of risperidone at the end of the study was 3.7 mg. Tolerance was excellent and only mild side-effects were reported. Vital signs, ECG-parameters, and laboratory values remained within normal limits. This study demonstrates that risperidone has great potential as an effective and well-tolerated alternative for the treatment of chronically psychotic patients. It has potent antipsychotic effects, a low EPS-inducing profile, and, at the same time, it improves the negative and affective symptoms of schizophrenia.

UI MeSH Term Description Entries
D007555 Isoxazoles Azoles with an OXYGEN and a NITROGEN next to each other at the 1,2 positions, in contrast to OXAZOLES that have nitrogens at the 1,3 positions. Isoxazole
D008297 Male Males
D008875 Middle Aged An adult aged 45 - 64 years. Middle Age
D010054 Brief Psychiatric Rating Scale A scale comprising 18 symptom constructs chosen to represent relatively independent dimensions of manifest psychopathology. The initial intended use was to provide more efficient assessment of treatment response in clinical psychopharmacology research; however, the scale was readily adapted to other uses. (From Hersen, M. and Bellack, A.S., Dictionary of Behavioral Assessment Techniques, p. 87) Overall and Gorham Brief Psychiatric Rating Scale,Overall-Gorham Brief Psychiatric Rating Scale,Overall Gorham Brief Psychiatric Rating Scale
D010865 Pilot Projects Small-scale tests of methods and procedures to be used on a larger scale if the pilot study demonstrates that these methods and procedures can work. Pilot Studies,Pilot Study,Pilot Project,Project, Pilot,Projects, Pilot,Studies, Pilot,Study, Pilot
D010880 Piperidines A family of hexahydropyridines.
D011618 Psychotic Disorders Disorders in which there is a loss of ego boundaries or a gross impairment in reality testing with delusions or prominent hallucinations. (From DSM-IV, 1994) Psychoses,Psychosis, Brief Reactive,Schizoaffective Disorder,Schizophreniform Disorders,Psychosis,Brief Reactive Psychoses,Brief Reactive Psychosis,Disorder, Psychotic,Disorder, Schizoaffective,Disorder, Schizophreniform,Disorders, Psychotic,Disorders, Schizoaffective,Disorders, Schizophreniform,Psychoses, Brief Reactive,Psychotic Disorder,Reactive Psychoses, Brief,Reactive Psychosis, Brief,Schizoaffective Disorders,Schizophreniform Disorder
D004341 Drug Evaluation Any process by which toxicity, metabolism, absorption, elimination, preferred route of administration, safe dosage range, etc., for a drug or group of drugs is determined through clinical assessment in humans or veterinary animals. Evaluation Studies, Drug,Drug Evaluation Studies,Drug Evaluation Study,Drug Evaluations,Evaluation Study, Drug,Evaluation, Drug,Evaluations, Drug,Studies, Drug Evaluation,Study, Drug Evaluation
D005260 Female Females
D006801 Humans Members of the species Homo sapiens. Homo sapiens,Man (Taxonomy),Human,Man, Modern,Modern Man

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