Risperidone versus haloperidol: I. Meta-analysis of efficacy and safety (original) (raw)
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Basic and clinical neuroscience, 2014
A number of research studies have shown that the new generation of neuroleptic medications can more effectively contribute to treating negative symptoms of schizophrenia compared with the first generation by influence cognitive functioning. The present study examined the therapeutic effectiveness of manufactured Risperidone and Haloperidol in Iran on treating the negative symptoms of schizophrenia. This randomized clinical trial (RCT) study examined 100 hospitalized patients who met DSM-IV. TR criteria for schizophrenia were sampled at Razi psychiatric hospital in Tehran, Iran. After two weeks of stopping neuroleptic medications, the patients were randomly assigned into two groups, Risperidone and Haloperidol group. During 8 weeks of the study, baseline and weekly assessments were performed by completing brief psychiatric report scale (BPRS). Both Risperidone and Haloperidol were effective in treating the negative symptoms of schizophrenia and improvements in both groups were initia...
Indian journal of psychiatry, 2000
The study compares the efficacy of risperidone and haloperidol in patients of schizophrenia on various clinical and psychosocial parameters.In the present open, comparative study, in patients suffering from schizophrenia (DSM-IV), 50 patients each were randomly treated with risperidone and haloperidol over a period of 1 year. The clinical improvement was judged on PANSS (Positive and Negative Symptom Scale) and CGIS (Clinical Global Impression Scale). The improvement in psychosocial functioning and other areas was judged using a five point scale (0-4). Though the improvement on PANSS was comparable in both the groups except on the general psychopathology subscale, on CGIS a better improvement profile was observed in risperidone group. In the other psychosocial areas such as social functioning, productivity and education a significantly more number of patients showed improvement in risperidone group as compared to haloperidol group. In significantly less number of patients suicidalit...
Journal of Clinical Psychopharmacology, 2010
Monotherapy is recommended for schizophrenia treatment, but the risk-benefit issue of antipsychotic drug combination (except for clozapine) remains unclear. Risperidone, an atypical antipsychotic drug, has a lower incidence of extrapyramidal syndrome but higher risks of prolactinemia and metabolic syndrome than haloperidol, a typical agent. This study compared efficacy and safety of risperidone monotherapy versus low-dose risperidone plus low-dose haloperidol in schizophrenia. In this 6-week, double-blind study, patients were randomized to the combination group (2-mg/d risperidone plus 2-mg/d haloperidol, n = 46) or the monotherapy group (4-mg/d risperidone, n = 42). Efficacy assessments included Clinical Global ImpressionVSeverity, Positive and Negative Syndrome Scale and subscales, Calgary Depression Scale, Global Assessment of Functioning, and Medical Outcomes Study Short-Form 36. Safety was rigorously monitored. Response was defined as 30% reduction in the Positive and Negative Syndrome Scale total score. The 2 treatment groups were similar in (1) demographic and clinical characteristics at baseline, (2) response rate, and (3) improvement in various psychopathological measures and quality of life at end point. The monotherapy group had a higher increase in prolactin levels (P = 0.04) and Simpson-Angus Scale scores (P = 0.04) and a higher percentage of biperiden use (P = 0.045). There were no significant between-group difference in changes in weight, vital signs, corrected QT interval, liver/renal function, fasting glucose level, and lipid profiles. The findings suggest that risperidone monotherapy may yield higher prolactin levels than a combination of low-dose risperidone plus low-dose haloperidol. The 2 treatment groups are similar in efficacy, life quality, and other safety profiles. Future long-term studies are warranted.
The International Journal of Neuropsychopharmacology, 2008
Patients with first-episode schizophrenia appear to respond to lower doses of neuroleptics, and to be more sensitive to developing extrapyramidal side-effects. The authors therefore compared in such patients the efficacy and extrapyramidal tolerability of comparatively low dosages of the atypical neuroleptic risperidone and of the conventional neuroleptic haloperidol. Risperidone was hypothesized to have better extrapyramidal tolerability and efficacy in treating negative symptoms. Patients were randomly assigned under double-blind conditions to receive risperidone (n=143) or haloperidol (n=146) for 8 wk. The primary efficacy criterion was the estimated difference in the mean change in the Positive and Negative Symptom Scale (PANSS) negative score between treatment groups ; secondary efficacy criteria were changes on the PANSS total score and other PANSS subscores, and several other measures of psychopathology and general functioning. The primary tolerability criterion was the difference in baseline-adjusted occurrence rates of extrapyramidal side-effects measured with the Simpson-Angus Scale (SAS) compared between treatment groups. The main hypothesis was that risperidone would be superior in terms of improving negative symptoms and lowering the risk of extrapyramidal symptoms. Secondary tolerability criteria were the other extrapyramidal symptoms, measured with the Hillside Akathisia Scale (HAS) and the Abnormal Involuntary Movement Scale (AIMS). The average mean daily doses were 3.8 mg (S.D.=1.5) for risperidone and 3.7 mg (S.D.=1.5) for haloperidol. There were similar, significant improvements in both treatment groups in the primary and secondary efficacy criteria. At week 8 nearly all scores of extrapyramidal side-effects indicated a significantly higher prevalence of extrapyramidal side-effects with haloperidol than with risperidone [SAS : risperidone 36.5 % of patients ; haloperidol 51.5 % of patients ; likelihood ratio test, x 2 (1)=7.8, p=0.005]. There were significantly fewer drop-outs [risperidone n=55, drop-out rate=38.5 % ; haloperidol n=79, drop-out rate=54.1 %, x 2 (1)=7.1, p=0.009] and a longer non-discontinuation time [risperidone : average of 50.8 d to drop-out ; haloperidol : average of 44.0 d to drop-out ; log rank test, x 2 (1)=6.4, p=0.011] in the risperidone group. Risperidone and haloperidol appear to be equally effective in treating negative and other symptoms of first-episode schizophrenia. Risperidone has better extrapyramidal tolerability and treatment retention rate than the equivalent dose of haloperidol in these patients.
Acta Psychiatrica Scandinavica, 1992
The purpose of this study was to compare the efficacy and safety of risperidone and haloperidol in treatment-resistant () chronic schizophrenic patients. Subjects n s 78 who met DSM-III criteria for schizophrenia were randomly assigned to receive 6 mgr r r r rday of risperidone or 20 mgr r r r rday of haloperidol for 12 weeks. Clinical efficacy was determined using the () () Positive and Negative Syndrome Scale PANSS , and side-effects with the Treatment Emergent Symptom Scale TESS. Risperidone produced a mean 39.8" 24.1% reduction in total PANSS score compared to a mean 28.3" 19.4% reduction () in the haloperidol group P-0.05. Analysis of changes for the three subscores of the PANSS revealed that the general psychopathology and negative subscores were significantly improved in the risperidone group compared to the haloperidol group. As for the side-effects, the risperidone group showed a significantly lower TESS total score, as well as nervous system symptoms subscore and cardiovascular symptoms subscore, compared to the haloperidol group. Risperidone appears to be a more effective and better tolerated antipsychotic drug in treatment-refractory Chinese schizophrenia than haloperidol. Int Clin Psychopharmacol 16:325᎐330 ᮊ
Risperidone in acute and long-term therapy of schizophrenia—a clinical profile
Progress in Neuro-Psychopharmacology and Biological Psychiatry, 2004
Data from a range of well-controlled clinical trials, observational studies, and clinical use support the efficacy of risperidone for both acute and long-term therapy of schizophrenic psychoses. With regard to positive symptoms, the efficacy of risperidone was shown to be at least comparable with that of haloperidol. However, risperidone differs from conventional antipsychotics because it is more effective against the negative symptoms, has beneficial effects on affective and cognitive symptoms, and carries less risk of extrapyramidal side effects (EPS). To date, risperidone is the only atypical antipsychotic to have shown a significantly lower relapse rate compared with haloperidol in a long-term double-blind trial. This review describes comprehensive trial data and therapeutic observations gained with risperidone in the treatment of schizophrenia since its approval.
European Archives of Psychiatry and Clinical Neuroscience, 1997
Results of a subanalysis of data from the multinational risperidone trial (RIS-INT-2) are reported. Patients with chronic schizophrenia were treated with risperidone at 1 mg/day (n = 25), 4 mg/day (n = 27), 8 mg/day (n = 29), 12 mg/day (n = 31), or 16 mg/day (n = 29), or 10 mg/day of haloperidol for 8 weeks. According to the Positive and Negative Syndrome Scale (PANSS) total and subscale scores, improvements were noted in each treatment group from baseline to treatment endpoint. On each scale the magnitude of improvement was greater in the risperidone patients than in the haloperidol patients. The onset of action of risperidone was faster than haloperidol. By treatment week 2, over half of the patients receiving > 4 mg/day of risperidone were clinically improved (> 20% reduction in total PANSS scores). This rate of improvement was not seen until week 6 in the haloperidol patients. Severity of extrapyramidal symptoms (scores on the Extrapyramidal Symptom Scale) was significantly lower in patients receiving 1 or 4 mg/day of risperidone than in patients receiving higher risperidone doses and in haloperidol patients. The optimal dose of risperidone, in terms of H.-J. M611er ([E~) Psychiatric Clinic, both efficacy and safety, was 4 mg/day. These results confirm the findings of the controlled trials of risperidone conducted in North America and the multinational trial.
The Canadian Journal of Psychiatry, 1998
The RIS-CAN-3 Study Group' Objective: Since most clinical trials of atypical antipsychotics have been conducted in hospitalized patients, a Phase-IV, multicentre, 8-week, open-label, flexible-dose study was performedto assess the efficacy andsafety ofrisperidone in outpatients with schizophrenia. Method: Three hundred and thirty patients with a Diagnostic and StatisticalManual ofMental Disorders (DSM-III-R) diagnosis ofschizophrenia were enrolled at 61 Canadian sites. Upon trial entry, the patients had their neuroleptic and antiparkinsonian drugs discontinued, and treatment with risperidone was initiated at a dose of2 mg daily, then increased by 2 mg daily on each ofthe 2 following days until the initial target dose of6 mg daily was reached on day 3. Nofurther titration was allowed until day 14, after which the dose could be increased or decreased. Results: During the stabilization phase (days 14-56), the dose was unchanged in 44% of the patients, increased in 24%, decreased in 23%, and titrated both up and down in 9% ofthepatients. In the efficacy-evaluable population (n = 292), treatment with risperidone produced substantial (-26.4) and significant (P = 0.0001) improvement in the total Positive and Negative Syndrome Scale (PANSS) score. At the end of the study (week 8), 85% ofpatients were classified as clinically improved according to an a priori definition (that is, 20% or more decrease from baseline in total PANSS score). On their last study visit, 75% ofpatients reported their experience with risperidone as better than their previous neuroleptic therapy. Risperidone was generally well tolerated. The adverse events reported by more than 5% of the patients were insomnia, nausea, headache, somnolence, dizziness,fatigue, anxiety, vomiting, and ejaculation disorder. Seventy-four percent ofthe reported treatment-related adverse events were recorded during the first 2 weeks of the trial, possibly because of the discontinuation ofprior neuroleptic and antiparkinsonian drugsfollowed by immediate upward titration ofrisperidone. However, only 8.5% ofadverse events were reported to have occurred during week 3, and only 0.8% ofadverse events were reportedfor week 8. Risperidone treatment produced significant improvements over baseline in the incidence and severity ofextrapyramidal symptoms (EPS). A slight but statistically significant increase in body weight was observed. Conclusions: The results ofthis open-label, Phase-IV trial in a large population ofoutpatients with schizophreniafound that risperidone was superior to the neuroleptics that patients had previously taken in terms ofefficacy and severity ofEPS. Our results suggest the use ofrisperidone at lower doses in outpatients with schizophrenia.