Risperidone in treatment-refractory schizophrenia.

Abstract

OBJECTIVE:

The purpose of this study was to evaluate the clinical safety and efficacy of risperidone compared to haloperidol in patients with treatment-refractory schizophrenia.

METHOD:

Sixty-seven medication-unresponsive subjects were randomly assigned to treatment with risperidone (N = 34) or haloperidol (N = 33). After a 3-7 day-placebo washout period, there was a 4-week, double-blind, fixed-dose comparison trial that was followed by a 4-week, flexible-dose phase. Measures of clinical change were quantified by standard psychopathologic and neuromotor instruments.

RESULTS:

Risperidone demonstrated clinical efficacy superior to that of haloperidol on the total Brief Psychiatric Rating Scale (BPRS) after the first 4 weeks of treatment. Risperidone did not show any advantage over haloperidol after an additional 4 weeks. Overall improvement on the BPRS at 4 weeks was significantly better for the risperidone group (24%) than for the haloperidol group (11%). Risperidone-treated subjects were significantly less likely than haloperidol-treated subjects to require concomitant anticholinergic medication after 4 weeks (20% versus 63%); they also had significantly les observable akathisia (24% versus 53%) and significantly less severe tardive dyskinesia. Baseline characteristics that correlated significantly with risperidone response were positive symptoms, conceptual disorganization, akathisia, and tardive dyskinesia.

CONCLUSIONS:

Risperidone was better tolerated and more effective in a subset of patients with treatment-refractory schizophrenia. Positive psychotic symptoms and extrapyramidal side effects at baseline appear to be powerful predictors of subsequent response to risperidone.

• Authors: D A Wirshing, B D Marshall Jr, M F Green, J Mintz, S R Marder, W C Wirshing
• Journal: The American journal of psychiatry (Am J Psychiatry) Vol. 156 Issue 9 Pg. 1374-9 (Sep 1999) ISSN: 0002-953X [Print] United States
• PMID: 10484947 (Publication Type: Clinical Trial, Comparative Study, Journal Article, Randomized Controlled Trial, Research Support, Non-U.S. Gov't, Research Support, U.S. Gov't, Non-P.H.S., Research Support, U.S. Gov't, P.H.S.)

Chemical References

• Antipsychotic Agents
• Cholinergic Antagonists
• Placebos
• Haloperidol
• Risperidone

Topics

• Adult
• Antipsychotic Agents (adverse effects, therapeutic use)
• Basal Ganglia Diseases (chemically induced, prevention & control)
• Brief Psychiatric Rating Scale (statistics & numerical data)
• Cholinergic Antagonists (administration & dosage)
• Double-Blind Method
• Drug Administration Schedule
• Dyskinesia, Drug-Induced (etiology, prevention & control)
• Female
• Haloperidol (adverse effects, therapeutic use)
• Humans
• Male
• Placebos
• Psychiatric Status Rating Scales (statistics & numerical data)
• Risperidone (adverse effects, therapeutic use)
• Schizophrenia (diagnosis, drug therapy)
• Schizophrenic Psychology
• Severity of Illness Index
• Treatment Outcome