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Comparative Study
. 2000;2003(2):CD000440.
doi: 10.1002/14651858.CD000440.

Risperidone versus typical antipsychotic medication for schizophrenia

E Kennedy  1 , F Song, R Hunter, A Clarke, S Gilbody
Affiliations
Comparative Study

Risperidone versus typical antipsychotic medication for schizophrenia

E Kennedy et al. Cochrane Database Syst Rev. 2000.

Update in

Abstract

Background: The 'conventional' neuroleptic drugs, such as haloperidol and chlorpromazine, are frequently used as the first line treatment for people with schizophrenia. However, about 5-25% of these people show poor response to these treatments and side effects often makes compliance with the 'older generation' of drug treatment problematic. Although the efficacy of these medications with respect to 'positive' symptoms is well described, little evidence exists that 'conventional' antipsychotic treatment has any effect on the 'negative' symptoms of schizophrenia. Risperidone is one of the 'new generation' neuroleptic compounds. As well as its reputed tendency to cause fewer movement disorders it is claimed that risperidone may improve negative symptoms.

Objectives: To evaluate the effectiveness of risperidone for schizophrenia in comparison to 'conventional' neuroleptic drugs.

Search strategy: Electronic searches of Biological Abstracts (1980-1997), Cochrane Schizophrenia Group's Register (1997), The Cochrane Library (1997, Issue1), EMBASE (1980-1997), MEDLINE (1966-1997), PsycLIT (1974-1997), and SCISEARCH (1997) were undertaken. References of all identified studies were searched for further trial citations. Pharmaceutical companies and authors of trials were contacted.

Selection criteria: All randomised trials comparing risperidone to any 'conventional' neuroleptic treatment for those with schizophrenia or other serious mental illnesses.

Data collection and analysis: Citations and, where possible, abstracts were independently inspected by reviewers, papers ordered, re-inspected and quality assessed. Data were also independently extracted. Sensitivity analyses on dose of risperidone, haloperidol and duration of illness were undertaken for the primary outcomes of clinical improvement, side effects (movement disorders) and acceptability of treatment. For homogeneous dichotomous data the odds ratio (OR), 95% confidence interval (CI) and, where appropriate, the number needed to treat (NNT) were calculated on an intention-to-treat basis.

Main results: Twelve short-term studies and two long term studies provided data on 3401 people. This review provides no evidence relating to the effect of risperidone on cognitive or social functioning, quality of life, employment status, discharge from hospital and relapse rates. Risperidone increases the odds of moderate clinical improvement (OR 0.65, CI 0.55-0.77, NNT 10, CI 7-16). It appears to have little or no additional effect on the positive and negative symptoms of schizophrenia but did have less tendency to cause movement disorders, largely in comparison with haloperidol (OR 0.43, CI 0.34-0.55, NNT 7, CI 5-10) for use of antiparkinsonian medication. Risperidone seems to be more acceptable to those with schizophrenia (OR 0.69 CI 0.57-0.83, NNT 15, CI 10-30, 30% baseline risk of dropping out). Those taking risperidone are also marginally less likely to experience somnolence (OR 0.78, CI 0. 61-0.99, NNT 22). Weight gain, however, is more likely with risperidone (OR 1.51 CI 1.14-2.00, NNT 13). Funnel plots show that smaller studies generally show greater benefit for risperidone than larger studies. A publication bias in favour of risperidone amongst the included studies may explain this effect. Sensitivity analyses on dose of risperidone (excluding those receiving 1 or 2 mg) did not materially change the results for the principal outcomes. Excluding data from those on higher doses of haloperidol (>10mg/day) does marginally change the results. Risperidone is less effective in achieving clinical improvement and preventing dropout but outcomes relating to movement disorders change little.

Reviewer's conclusions: Little can be concluded about the long term effects of risperidone and generalising results beyond a comparison with haloperidol would be imprudent. Risperidone may be more acceptable to those with schizophrenia and have marginal benefits in terms of limited clinical improvement and side

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Conflict of interest statement

None.

Figures

1.1
1.1. Analysis
Comparison 1 RISPERIDONE vs TYPICAL NEUROLEPTIC MEDICATION, Outcome 1 Global state: 1. Not improved to a clinically important degree (using BPRS).
1.2
1.2. Analysis
Comparison 1 RISPERIDONE vs TYPICAL NEUROLEPTIC MEDICATION, Outcome 2 Global state: 2. Not improved to a clinically important degree (using CGI).
1.3
1.3. Analysis
Comparison 1 RISPERIDONE vs TYPICAL NEUROLEPTIC MEDICATION, Outcome 3 Global state: 3. Not improved to a clinically important degree (no greater than 20% change in PANSS score).
1.4
1.4. Analysis
Comparison 1 RISPERIDONE vs TYPICAL NEUROLEPTIC MEDICATION, Outcome 4 Global state: 4. Not improved to a clinically important degree (no greater than 40% change in PANSS score).
1.5
1.5. Analysis
Comparison 1 RISPERIDONE vs TYPICAL NEUROLEPTIC MEDICATION, Outcome 5 Global state: 5. Not improved to a clinically important degree (no greater than 60% chnage in PANSS score).
1.6
1.6. Analysis
Comparison 1 RISPERIDONE vs TYPICAL NEUROLEPTIC MEDICATION, Outcome 6 Global state: 6. Not improved to a clinically important degree (as rated by participants).
1.7
1.7. Analysis
Comparison 1 RISPERIDONE vs TYPICAL NEUROLEPTIC MEDICATION, Outcome 7 Global state: 7a. Relapse ‐ by 1 year.
1.9
1.9. Analysis
Comparison 1 RISPERIDONE vs TYPICAL NEUROLEPTIC MEDICATION, Outcome 9 Global state: 6. Unable to be discharged from hospital by 8 weeks.
1.10
1.10. Analysis
Comparison 1 RISPERIDONE vs TYPICAL NEUROLEPTIC MEDICATION, Outcome 10 Global state: 6. Change in CGI (continuous, high score = poor)*.
1.11
1.11. Analysis
Comparison 1 RISPERIDONE vs TYPICAL NEUROLEPTIC MEDICATION, Outcome 11 Mental state: 1. Change in PANSS by 12 weeks ‐ total (continuous, high score = poor)*.
1.12
1.12. Analysis
Comparison 1 RISPERIDONE vs TYPICAL NEUROLEPTIC MEDICATION, Outcome 12 Mental state: 2. Change in PANSS by 12 weeks ‐ negative (continuous, high score = poor)*.
1.13
1.13. Analysis
Comparison 1 RISPERIDONE vs TYPICAL NEUROLEPTIC MEDICATION, Outcome 13 Mental state: 3. Change in PANSS by 12 weeks ‐ positive (continuous, high score = poor)*.
1.14
1.14. Analysis
Comparison 1 RISPERIDONE vs TYPICAL NEUROLEPTIC MEDICATION, Outcome 14 Mental state: 4. Change in BPRS by 12 weeks (continuous, high score = poor)*.
1.15
1.15. Analysis
Comparison 1 RISPERIDONE vs TYPICAL NEUROLEPTIC MEDICATION, Outcome 15 Mental state: 5. PANSS endpoint score by 6 weeks (continuous, high score = poor).
1.16
1.16. Analysis
Comparison 1 RISPERIDONE vs TYPICAL NEUROLEPTIC MEDICATION, Outcome 16 Mental state: 6. Anxiety/tension: short‐term (up to 12 weeks).
1.17
1.17. Analysis
Comparison 1 RISPERIDONE vs TYPICAL NEUROLEPTIC MEDICATION, Outcome 17 Mental state: 7. Depression: short‐term (up to 12 weeks).
1.18
1.18. Analysis
Comparison 1 RISPERIDONE vs TYPICAL NEUROLEPTIC MEDICATION, Outcome 18 Behaviour: 1. Agitation: short‐term (up to 12 weeks).
1.19
1.19. Analysis
Comparison 1 RISPERIDONE vs TYPICAL NEUROLEPTIC MEDICATION, Outcome 19 Behaviour: 2. Use of medication for sedation: short‐term (up to 12 weeks).
1.20
1.20. Analysis
Comparison 1 RISPERIDONE vs TYPICAL NEUROLEPTIC MEDICATION, Outcome 20 Cognitive function: short‐term (up to 12 weeks).
1.21
1.21. Analysis
Comparison 1 RISPERIDONE vs TYPICAL NEUROLEPTIC MEDICATION, Outcome 21 Acceptability of treatment: 1a. Leaving study early ‐ adverse effect.
1.22
1.22. Analysis
Comparison 1 RISPERIDONE vs TYPICAL NEUROLEPTIC MEDICATION, Outcome 22 Acceptability of treatment: 1b. Leaving study early ‐ insufficient response.
1.23
1.23. Analysis
Comparison 1 RISPERIDONE vs TYPICAL NEUROLEPTIC MEDICATION, Outcome 23 Acceptability of treatment: 1c. Leaving the study early ‐ any reason.
1.24
1.24. Analysis
Comparison 1 RISPERIDONE vs TYPICAL NEUROLEPTIC MEDICATION, Outcome 24 Acceptability of treatment: 2. Not acceptable ‐ as measured by direct questioning.
1.25
1.25. Analysis
Comparison 1 RISPERIDONE vs TYPICAL NEUROLEPTIC MEDICATION, Outcome 25 Adverse effects: 1. Experiencing at least one adverse effect.
1.26
1.26. Analysis
Comparison 1 RISPERIDONE vs TYPICAL NEUROLEPTIC MEDICATION, Outcome 26 Adverse effects: 2. Movement disorders ‐ general.
1.27
1.27. Analysis
Comparison 1 RISPERIDONE vs TYPICAL NEUROLEPTIC MEDICATION, Outcome 27 Adverse effects: 3. Movement disorders ‐ specific.
1.28
1.28. Analysis
Comparison 1 RISPERIDONE vs TYPICAL NEUROLEPTIC MEDICATION, Outcome 28 Adverse effects: 4. Movement disorders ‐ change in CGI (high score = poor).
1.29
1.29. Analysis
Comparison 1 RISPERIDONE vs TYPICAL NEUROLEPTIC MEDICATION, Outcome 29 Adverse effects: 5. Movement disorders ‐ change in ESRS (high score = poor).
1.30
1.30. Analysis
Comparison 1 RISPERIDONE vs TYPICAL NEUROLEPTIC MEDICATION, Outcome 30 Adverse effects: 6. Movement disorders ‐ change in UKU (high score = poor).
1.31
1.31. Analysis
Comparison 1 RISPERIDONE vs TYPICAL NEUROLEPTIC MEDICATION, Outcome 31 Adverse effects: 7. SAS endpoint score by 6 weeks ( high score = poor).
1.32
1.32. Analysis
Comparison 1 RISPERIDONE vs TYPICAL NEUROLEPTIC MEDICATION, Outcome 32 Adverse effects: 8. Anticholinergic effects (dry mouth, blurred vision, constipation, urinary difficulties).
1.33
1.33. Analysis
Comparison 1 RISPERIDONE vs TYPICAL NEUROLEPTIC MEDICATION, Outcome 33 Adverse effects: 9. Sleep problems.
1.34
1.34. Analysis
Comparison 1 RISPERIDONE vs TYPICAL NEUROLEPTIC MEDICATION, Outcome 34 Adverse effects: 10. Weight change.
1.35
1.35. Analysis
Comparison 1 RISPERIDONE vs TYPICAL NEUROLEPTIC MEDICATION, Outcome 35 Adverse effects: 11. Gastrointestinal problems.
1.36
1.36. Analysis
Comparison 1 RISPERIDONE vs TYPICAL NEUROLEPTIC MEDICATION, Outcome 36 Adverse effects: 12. Central nervous system.
1.37
1.37. Analysis
Comparison 1 RISPERIDONE vs TYPICAL NEUROLEPTIC MEDICATION, Outcome 37 Adverse effects: 13. Cardiovascular.
1.38
1.38. Analysis
Comparison 1 RISPERIDONE vs TYPICAL NEUROLEPTIC MEDICATION, Outcome 38 Adverse effects: 14. Sexual problems.
1.39
1.39. Analysis
Comparison 1 RISPERIDONE vs TYPICAL NEUROLEPTIC MEDICATION, Outcome 39 Adverse effects: 15. Menstrual problems.
1.40
1.40. Analysis
Comparison 1 RISPERIDONE vs TYPICAL NEUROLEPTIC MEDICATION, Outcome 40 Adverse effects: 16. Other.
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Kopala 1996 {published data only}
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Murasaki 1995 {published data only}
    1. Murasaki M, Miura S. [Risperidone in the treatment of schizophrenia: A double‐blind comparison with haloperidol]. 8th ECNP ( European College of Neuropyschopharmacology) Congress; 1995 September 30th ‐ October 4th; Venice, Italy. 1995.
    1. Murasaki M, Yamashita I, Machiyama Y, Yamauchi T, Okuma T, Toru M, Ushijima S, Kamijima K, Yagi G, Miura S. Efficacy of a new antipsychotic, risperidone on schizophrenia. Clinical Evaluation 1993;21:221‐59.
Nagao 1998 {published data only}
    1. Nagao M, Mori K, Kobayakawa M, Hirayama S, Harada Y, Kashiwagi K, Irisawa T, Nagao K. Quantitative electoencephalography in schizophrenia: therapeutic effects of haloperidol and risperidone. 11th Congress of the European College of Neuropsychopharmacology; 1998 October 31‐ November 4; Paris, France. 1998.
Pathiraja 1995 {published data only}
    1. Pathiraja AP, Diamond BI, Borison RL, Meibech RC, Anand R. Relationship between creatine phosphokinase, psychotic symptoms and novel antipsychotic drugs. Schizophrenia Research 1995;15(1‐2):160‐1.
Sikich 2001 {published data only}
    1. Sikich L, Hooper SR, Malekpour AH, Sheitman BB, Lieberman JA. A double blind comparison of typical versus atypical antipsychotic agents on selected neurocognitive functions in children and adolescents with psychotic disorders. Abstracts of the VIII International Congress on Schizophrenia Research; 2001 April 28‐May 2; British Columbia, Canada. 2001.
Zhou 1998 {published data only}
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References to ongoing studies

Armenteros 2001 {published data only}
    1. Risperidone treatment of adolescents with schizophrenia.. Ongoing study March 1998.
Lacro 2001 {published data only}
    1. Antipsychotic treatment in late life schizophrenia.. Ongoing study July 1997.
Lieberman 2001 {published data only}
    1. Risperidone and clozapine in chronic schizophrenia.. Ongoing study Starting date of trial not provided. Contact author for more information.
Reveley 2000 {published data only}
    1. Ris‐int‐35 a double blind evaluation of risperidone versus haloperidol on the long‐term morbidity of early psychotic patients. Ongoing study Nov 1996.
Tonmoy 2000 {published data only}
    1. A double‐blind evaluation of risperidone versus haloperidol on the long‐term morbidity of early psychotic patients.. Ongoing study Trial now complete but not yet published.
Woods 2000 {published data only}
    1. Atypical antipsychotic medications ‐ outcomes and costs.. Ongoing study Not given..

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