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Meta-Analysis
. 2016 Dec 15;12(12):CD006918.
doi: 10.1002/14651858.CD006918.pub3.

Risperidone versus placebo for schizophrenia

Ranganath D Rattehalli  1 , Sai Zhao  2 , Bao Guo Li  3 , Mahesh B Jayaram  4 , Jun Xia  5 , Stephanie Sampson  6
Affiliations
Meta-Analysis

Risperidone versus placebo for schizophrenia

Ranganath D Rattehalli et al. Cochrane Database Syst Rev. .

Abstract

Background: Risperidone is the first new-generation antipsychotic drug made available in the market in its generic form.

Objectives: To determine the clinical effects, safety and cost-effectiveness of risperidone compared with placebo for treating schizophrenia.

Search methods: On 19th October 2015, we searched the Cochrane Schizophrenia Group Trials Register, which is based on regular searches of CINAHL, BIOSIS, AMED, EMBASE, PubMed, MEDLINE, PsycINFO, and registries of clinical trials. We checked the references of all included studies and contacted industry and authors of included studies for relevant studies and data.

Selection criteria: Randomised clinical trials (RCTs) comparing oral risperidone with placebo treatments for people with schizophrenia and/or schizophrenia-like psychoses.

Data collection and analysis: Two review authors independently screened studies, assessed the risk of bias of included studies and extracted data. For dichotomous data, we calculated the risk ratio (RR), and the 95% confidence interval (CI) on an intention-to-treat basis. For continuous data, we calculated mean differences (MD) and the 95% CI. We created a 'Summary of findings table' using GRADE (Grading of Recommendations Assessment, Development and Evaluation).

Main results: The review includes 15 studies (N = 2428). Risk of selection bias is unclear in most of the studies, especially concerning allocation concealment. Other areas of risk such as missing data and selective reporting also caused some concern, although not affected on the direction of effect of our primary outcome, as demonstrated by sensitivity analysis. Many of the included trials have industry sponsorship of involvement. Nonetheless, generally people in the risperidone group are more likely to achieve a significant clinical improvement in mental state (6 RCTs, N = 864, RR 0.64, CI 0.52 to 0.78, very low-quality evidence). The effect withstood, even when three studies with >50% attrition rate were removed from the analysis (3 RCTs, N = 589, RR 0.77, CI 0.67 to 0.88). Participants receiving placebo were less likely to have a clinically significant improvement on Clinical Global Impression scale (CGI) than those receiving risperidone (4 RCTs, N = 594, RR 0.69, CI 0.57 to 0.83, very low-quality evidence). Overall, the risperidone group was 31% less likely to leave early compared to placebo group (12 RCTs, N = 2261, RR 0.69, 95% CI 0.62 to 0.78, low-quality evidence), but Incidence of significant extrapyramidal side effect was more likely to occur in the risperidone group (7 RCTs, N = 1511, RR 1.56, 95% CI 1.13 to 2.15, very low-quality evidence).When risperidone and placebo were augmented with clozapine, there is no significant differences between groups for clinical response as defined by a less than 20% reduction in PANSS/BPRS scores (2 RCTs, N = 98, RR 1.15, 95% CI 0.93 to 1.42, low-quality evidence) and attrition (leaving the study early for any reason) (3 RCTs, N = 167, RR 1.13, 95% CI 0.53 to 2.42, low quality evidence). One study measured clinically significant responses using the CGI, no effect was evident (1 RCT, N = 68, RR 1.12 95% CI 0.87 to 1.44, low quality evidence). No data were available for extrapyramidal adverse effects.

Authors' conclusions: Based on low quality evidence, risperidone appears to be benefitial in improving mental state compared with placebo, but it also causes more adverse events. Eight out of the 15 included trials were funded by pharmaceutical companies. The currently available evidence isvery low to low quality.

PubMed Disclaimer

Conflict of interest statement

RR: none known. SZ: none known. BL: none known. MJ: none known. JX: none known. SS: none known.

Figures

1
1
Risperidone
2
2
Study flow diagram.
3
3
Risk of bias graph: review authors' judgements about each risk of bias item presented as percentages across all included studies.
4
4
Methodological quality summary: review authors' judgements about each methodological quality item for each included study.
1.1
1.1. Analysis
Comparison 1 RISPERIDONE vs PLACEBO, Outcome 1 Mental state: no clinically significant response in psychotic symptoms (defined by various scale total score change) ‐ short term (up to 12 weeks).
1.2
1.2. Analysis
Comparison 1 RISPERIDONE vs PLACEBO, Outcome 2 Leaving the study early ‐ short term (up to 12 weeks).
1.3
1.3. Analysis
Comparison 1 RISPERIDONE vs PLACEBO, Outcome 3 Global state: 1. average endpoint scores of CGI severity scale (high=poor) ‐ short term (up to 12 weeks).
1.4
1.4. Analysis
Comparison 1 RISPERIDONE vs PLACEBO, Outcome 4 Global state: 2. no significant clinical improvement CGI ‐ short term (up to 12 weeks).
1.5
1.5. Analysis
Comparison 1 RISPERIDONE vs PLACEBO, Outcome 5 Global state: 3. needing additional medication ‐ short term (up to 12 weeks).
1.6
1.6. Analysis
Comparison 1 RISPERIDONE vs PLACEBO, Outcome 6 Mental state: 1. average endpoint scores on various scales on psychotic symptoms (high=poor) ‐ short term (up to 12 weeks).
1.8
1.8. Analysis
Comparison 1 RISPERIDONE vs PLACEBO, Outcome 8 Adverse effects: 1a. extrapyramidal ‐ various effects ‐ short term (up to 12 weeks).
1.9
1.9. Analysis
Comparison 1 RISPERIDONE vs PLACEBO, Outcome 9 Adverse effects: 1b. extrapyramidal ‐ AIMS average endpoint score ‐ short term (up to 12 weeks).
1.11
1.11. Analysis
Comparison 1 RISPERIDONE vs PLACEBO, Outcome 11 Adverse effects: 2. any adverse event ‐ short term (up to 12 weeks).
1.12
1.12. Analysis
Comparison 1 RISPERIDONE vs PLACEBO, Outcome 12 Adverse effects: 3. cardiovascular ‐ short term (up to 12 weeks).
1.13
1.13. Analysis
Comparison 1 RISPERIDONE vs PLACEBO, Outcome 13 Adverse effects: 4. central nervous system ‐ short term (up to 12 weeks).
1.14
1.14. Analysis
Comparison 1 RISPERIDONE vs PLACEBO, Outcome 14 Adverse effects: 5. endocrine ‐ serum prolactin increase above reference range (23 ng/ml) ‐ short term (up to 12 weeks).
1.15
1.15. Analysis
Comparison 1 RISPERIDONE vs PLACEBO, Outcome 15 Adverse effects: 6. gastrointestinal system ‐ short term (up to 12 weeks).
1.16
1.16. Analysis
Comparison 1 RISPERIDONE vs PLACEBO, Outcome 16 Adverse effects: 7a. metabolic ‐ weight gain ‐ short term (up to 12 weeks).
1.18
1.18. Analysis
Comparison 1 RISPERIDONE vs PLACEBO, Outcome 18 Adverse effects: 8. musculoskeletal system ‐ short term (up to 12 weeks).
1.19
1.19. Analysis
Comparison 1 RISPERIDONE vs PLACEBO, Outcome 19 Adverse effects: 9. physiology ‐ short term (up to 12 weeks).
1.20
1.20. Analysis
Comparison 1 RISPERIDONE vs PLACEBO, Outcome 20 Adverse effects: 10. respiratory system ‐ short term (up to 12 weeks).
2.1
2.1. Analysis
Comparison 2 RISPERIDONE + CLOZAPINE vs PLACEBO + CLOZAPINE, Outcome 1 Mental state: no clinically significant response in psychotic symptoms (defined by PANSS/BPRS<20% decline) ‐ short term (up to 12 weeks).
2.2
2.2. Analysis
Comparison 2 RISPERIDONE + CLOZAPINE vs PLACEBO + CLOZAPINE, Outcome 2 Leaving the study early ‐ short term (up to 12 weeks).
2.3
2.3. Analysis
Comparison 2 RISPERIDONE + CLOZAPINE vs PLACEBO + CLOZAPINE, Outcome 3 Global state: 1. average endpoint scores of CGI severity scale (high=poor) ‐ short term (up to 12 weeks).
2.4
2.4. Analysis
Comparison 2 RISPERIDONE + CLOZAPINE vs PLACEBO + CLOZAPINE, Outcome 4 Global state: 2. no significant clinical improvement CGI ‐ short term (up to 12 weeks).
2.5
2.5. Analysis
Comparison 2 RISPERIDONE + CLOZAPINE vs PLACEBO + CLOZAPINE, Outcome 5 Global state: 3. general functioning ‐ average endpoint GAF score (high=good) ‐ short term (up to 12 weeks).
2.6
2.6. Analysis
Comparison 2 RISPERIDONE + CLOZAPINE vs PLACEBO + CLOZAPINE, Outcome 6 Mental state: 1. average endpoint scores on various scales on psychotic symptoms (high=poor) ‐ short term (up to 12 weeks).
2.7
2.7. Analysis
Comparison 2 RISPERIDONE + CLOZAPINE vs PLACEBO + CLOZAPINE, Outcome 7 Mental state: 2. average endpoint scores on various scales on psychotic symptoms (high=poor) ‐ medium term (up to 26 weeks).
2.9
2.9. Analysis
Comparison 2 RISPERIDONE + CLOZAPINE vs PLACEBO + CLOZAPINE, Outcome 9 Adverse effects: 1a. extrapyramidal ‐ average endpoint SAS score ‐ short term (up to 12 weeks).
2.12
2.12. Analysis
Comparison 2 RISPERIDONE + CLOZAPINE vs PLACEBO + CLOZAPINE, Outcome 12 Adverse effects: 2. any adverse event ‐ short term (up to 12 weeks).
2.13
2.13. Analysis
Comparison 2 RISPERIDONE + CLOZAPINE vs PLACEBO + CLOZAPINE, Outcome 13 Adverse effects: 3a. cardiovascular ‐ short term (up to 12 weeks).
2.14
2.14. Analysis
Comparison 2 RISPERIDONE + CLOZAPINE vs PLACEBO + CLOZAPINE, Outcome 14 Adverse effects: 3b. cardiovascular ‐ QTc interval ‐ short term (up to 12 weeks).
2.15
2.15. Analysis
Comparison 2 RISPERIDONE + CLOZAPINE vs PLACEBO + CLOZAPINE, Outcome 15 Adverse effects: 4. central nervous system ‐ short term (up to 12 weeks).
2.16
2.16. Analysis
Comparison 2 RISPERIDONE + CLOZAPINE vs PLACEBO + CLOZAPINE, Outcome 16 Adverse effects: 5. gastrointestinal system ‐ short term (up to 12 weeks).
2.17
2.17. Analysis
Comparison 2 RISPERIDONE + CLOZAPINE vs PLACEBO + CLOZAPINE, Outcome 17 Adverse effects: 6a. haematological ‐ short term (up to 12 weeks).
2.18
2.18. Analysis
Comparison 2 RISPERIDONE + CLOZAPINE vs PLACEBO + CLOZAPINE, Outcome 18 Adverse effects: 6b. haematological ‐ medium term (up to 26 weeks).
2.19
2.19. Analysis
Comparison 2 RISPERIDONE + CLOZAPINE vs PLACEBO + CLOZAPINE, Outcome 19 Adverse effects: 7a. metabolic ‐ weight gain ‐ short term (up to 12 weeks).
2.20
2.20. Analysis
Comparison 2 RISPERIDONE + CLOZAPINE vs PLACEBO + CLOZAPINE, Outcome 20 Adverse effects: 7a. metabolic ‐ weight gain ‐ medium term (up to 26 weeks).
2.21
2.21. Analysis
Comparison 2 RISPERIDONE + CLOZAPINE vs PLACEBO + CLOZAPINE, Outcome 21 Adverse effects: 7b. metabolic ‐ average endpoint value on lipid profile ‐ short term (up to 12 weeks).
2.22
2.22. Analysis
Comparison 2 RISPERIDONE + CLOZAPINE vs PLACEBO + CLOZAPINE, Outcome 22 Adverse effects: 7c. metabolic ‐ average endpoint value ‐ short term (up to 12 weeks).
2.24
2.24. Analysis
Comparison 2 RISPERIDONE + CLOZAPINE vs PLACEBO + CLOZAPINE, Outcome 24 Quality of life: average endpoint score (QLS, high=good) ‐ short term (up to 12 weeks).
3.1
3.1. Analysis
Comparison 3 SENSITIVITY ANALYSIS: RISPERIDONE vs PLACEBO (based on attrition), Outcome 1 Mental state: 1. no clinically significant response (defined by PANSS/BPRS) ‐ short term (up to 12 weeks).
See this image and copyright information in PMC

Update of

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Borison 1992a {published data only}
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Boyer 1995 {published data only}
    1. Boyer P, Lecrubier Y, Puech AJ. Treatment of positive and negative symptoms: pharmacologic approaches. In: Andreasen NC editor(s). Modern problems of pharmacopsychiatry. Vol. 24, Basel, Switzerland: S. Karger, 1990:152‐74. - PubMed
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Brecher 1998 {published data only}
    1. Brecher M. Risperidone versus olanzapine in the treatment of patients with schizophrenia or schizoaffective disorder. Proceedings of the 11th European College of Neuropsychopharmacology Congress; 1998 Oct 31‐Nov 4; Paris, France. 1998.
    1. Brecher M, The Risperidone Olanzapine Study Group. Risperidone versus olanzapine in the treatment of patients with schizophrenia or schizoaffective disorder. Proceedings of the 21st Collegium Internationale Neuro‐Psychopharmacologicum Congress; 1998 Jul 12‐16; Glasgow, UK. 1998.
    1. Brecher M, The Risperidone‐Olanzapine Study Group. Risperidone versus olanzapine in the treatment of patients with schizophrenia or schizoaffective disorder conference abstract. Schizophrenia Research 1999;36(1‐3):271.
Cada 2004 {published data only}
    1. Cada DJ, Levien T, Baker DE. Risperidone long‐acting injection. Hospital Pharmacy 2004;39(4):353‐62.
Carson 2002 {published data only}
    1. Carson W, Cornblatt B, Saha A, Ali M, Kern R, Green M. Neurocognitive benefits of aripiprazole versus olanzapine in stable psychosis. European Neuropsychopharmacology 2002;12(Suppl 3):S291.
    1. Carson W, McQuade R, Saha A, Torbeyns A, Stock E. Aripiprazole versus placebo for relapse prevention in patients with chronic schizophrenia. European Neuropsychopharmacology 2002;12(Suppl 3):S288.
    1. Carson W, Pigott T, Saha A, Ali M, McQuade RD, Torbeyns AF, et al. Aripiprazole vs placebo in the treatment of stable, chronic schizophrenia. Proceedings of the 156th Annual Meeting of the American Psychiatric Association; 2003 May 17‐22; San Francisco, California, USA. 2003.
    1. Carson WH, Ali M, Dunbar G, Ingenito G, Saha AR. A double‐blind, placebo‐controlled trial of aripiprazole and haloperidol. Schizophrenia Research 2001;49(1,2):221‐2.
    1. Carson WH, Ali M, Saha AR, Dunbar GC, Ingenito G. A double‐blind, placebo‐controlled trial of aripiprazole and haloperidol in patients with schizophrenia or schizoaffective disorder. Proceedings of the 39th Annual Meeting of the American College of Neuropsychopharmacology; 2000 Dec 10‐14; San Juan, Puerto Rico. 2000.
Casey 2003 {published data only}
    1. Casey D, Barbato LM, Heisterberg J, Yeung PP, Shapira NA. Results of a bifeprunox dose‐finding study in patients with acutely exacerbated schizophrenia. Schizophrenia Bulletin 2007;33(2):425.
    1. Casey D, Saha A, Marcus R, Carson WH, McQuade RD, Torbeyns AF, et al. Aripiprazole versus placebo for relapse prevention in patients with chronic schizophrenia. Schizophrenia Research 2003;60(1):276.
    1. Casey D, Saha AR, Ali MW, Jody DN, Kujawa MJ, Stock EG, et al. Switching to aripiprazole monotherapy. International Journal of Neuropsychopharmacology 2002;5(Suppl 1):S187.
    1. Casey DE, Barbato LM, Heisterberg J, Yeung PP, Shapira NA. Results of a bifeprunox dose‐finding study in patients with acutely exacerbated schizophrenia. Proceedings of the 11th International Congress on Schizophrenia Research; 2007 Mar 28‐Apr 1, Colorado Springs, Colorado, USA 2007.
    1. Casey DE, Carson WH, Saha AR, Liebeskind A, Ali MW, Jody D, et al. Switching patients to aripiprazole from other antipsychotic agents: A multicenter randomized study. Psychopharmacology 2003;166(4):391‐9. - PubMed
Castle 2015 {published data only}
    1. Castle DJ, Jensen JKS. Management of depressive symptoms in schizophrenia: A pooled, post hoc analysis from the asenapine development program. Clinical Schizophrenia and Related Psychoses 2015;9:13‐20. - PubMed
Chan 2007 {published data only}
    1. Chan H‐Y, Lin W‐W, Lin S‐K, Hwang T‐J, Su T‐P, Chiang S‐C, et al. Efficacy and safety of aripiprazole in the acute treatment of schizophrenia in Chinese patients with risperidone as an active control: a randomized trial. Journal of Clinical Psychiatry 2007;68(1):29‐36. - PubMed
Chue 2002 {published data only}
    1. Chue P, Eerdekens M, Augustyns I, Lachaux B, Molcan P, Eriksson L, et al. Comparative efficacy and safety of long‐acting risperidone and risperidone oral tablets. European Neuropsychopharmacology 2005;15(1):111‐7. - PubMed
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    1. Chue P, Eerdekens M, Augustyns I, Lachaux B, Molcan P, Eriksson L, et al. Efficacy and safety of long‐acting risperidone microspheres and risperidone oral tablets. Proceedings of the 11th Biennial Winter Workshop on Schizophrenia; 2002 Feb 24‐Mar 1; Davos, Switzerland. 2002.
    1. Chue P, Eerdekens M, Augustyns I, Lachaux B, Molcan P, Eriksson L, et al. Maintenance of efficacy when switching from oral risperdal to risperdal consta RIS‐INT‐61. Poster supplied by Company 2002.
Ciliberto 2005 {published data only}
    1. Ciliberto N, Bossie CA, Urioste R, Lasser RA. Lack of impact of race on the efficacy and safety of long‐acting risperidone versus placebo in patients with schizophrenia or schizoaffective disorder. International Clinical Psychopharmacology 2005;20(4):207‐12. - PubMed
Citrome 2004 {published data only}
    1. Citrome L, Casey DE, Daniel DG, Wozniak P, Kochan LD, Tracy KA. Adjunctive divalproex and hostility among patients with schizophrenia receiving olanzapine or risperidone. Psychiatric Services 2004;55(3):290‐4. - PubMed
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Claus 1992 {published data only}
    1. Claus A, Bollen J, Cuyper H, Eneman M, Malfroid M, Peuskens J, et al. Risperidone versus haloperidol in the treatment of chronic schizophrenic inpatients: a multicentre double‐blind comparative study. Acta Psychiatrica Scandinavica 1992;85(4):295‐305. - PubMed
Conley 1998 {published data only}
    1. Conley RR, Brecher M, The Risperidone/Olanzapine Study Group. Risperidone versus olanzapine in patients with schizophrenia or schizoaffective disorders. Proceedings of the 11th European College of Neuropsychopharmacology Congress; 1998 Oct 31‐Nov 4; Paris, France. 1998.
    1. Conley RR, Brecher MB, Olanzapine‐Risperidone Study Group. Risperidone versus olanzapine in the treatment of patients with schizophrenia or schizoaffective disorder. Proceedings of the 152nd Annual Meeting of the American Psychiatric Association; 1999 May 15‐20; Washington DC, USA. 1999.
    1. Conley RR, Mahmoud R. A randomized double‐blind study of risperidone and olanzapine in the treatment of schizophrenia or schizoaffective disorder. American Journal of Psychiatry 2001; Vol. 158, issue 5:765‐74. - PubMed
    1. Conley RR, Mahmoud R. Efficacy of risperidone vs. olanzapine in the treatment of patients with schizophrenia or schizoaffective disorder. European Neuropsychopharmacology 2000;10(Suppl 3):S343. [13th Congress of the European College of Neuropsychopharmacology [CD‐ROM]: Conifer, Excerpta Medica Medical Communications BV, 2000 P3021]
    1. Conley RR, Mahmoud R. Efficacy of risperidone vs. olanzapine in the treatment of patients with schizophrenia or schizoaffective disorder. International Journal of Neuropsychopharmacology 2000;3(Suppl 1):S151.
Cooper 1997 {published data only}
    1. Cooper SJ, Butler A, Tweed J, Raniwalla J, Welch C. Zotepine in the prevention of relapse. Proceedings of the 6th World Congress of Biological Psychiatry; 1997 Jun 22‐27; Nice, France. 1997.
    1. Cooper SJ, Butler A, Tweed JA, Welch CP, Wighton AJ, Appleby P, et al. Zotepine is effective in preventing recurrence in patients with chronic schizophrenia. Proceedings of the 11th European College of Neuropsychopharmacology Congress; 1998 Oct 31‐Nov 4; Paris, France. 1998.
    1. Cooper SJ, Butler A, Tweed JA, Welch CP, Wighton AJ, Appleby P, et al. Zotepine is effective in preventing recurrence in patients with chronic schizophrenia. Schizophrenia Research 2000;41(1):207‐8.
    1. Cooper TB, Volavka J, Czobor P. Plasma drug level and clinical response. Journal of Clinical Psychopharmacology 1992;12(2):134‐6. - PubMed
Cornblatt 2002 {published data only}
    1. Cornblatt B, Kern RS, Carson WH, Ali MW, Luo X, Green M. Neurocognitive effects of aripiprazole versus olanzapine in stable psychosis. International Journal of Neuropsychopharmacology 2002;5(Suppl 1):S185.
    1. Cornblatt B, Kern RS, Carson WH, Stock E, Ali M, Ingenito G, et al. Neurocognitive effects of aripiprazole versus olanzapine in patients with stabile psychosis. Journal of Psychopharmacology 2002;16(Suppl 3):A15.
    1. Cornblatt B, Kern RS, Carson WH, Stock E, Ali M, Ingenito G, et al. Neurocognitive effects of aripiprazole versus olanzapine in patients with stable psychosis. Schizophrenia Research 2002;53(3 Suppl 1):27.
Crawford 1997 {published data only}
    1. Crawford AM, Beasley CM, Tollefson GD. Olanzapine ‐ impact of an atypical antipsychotic candidate on prolactin release. Proceedings of the 149th Annual Meeting of the American Psychiatric Association; 1996 May 4‐9, New York, New York, USA. 1996.
    1. Crawford AM, Beasley CM, Tollefson GD. The acute and long‐term effect of olanzapine compared with placebo and haloperidol on serum prolactin concentrations. European Neuropsychopharmacology 1997;7(Suppl 2):199. - PubMed
    1. Crawford AM, Beasley CM, Tollefson GD. The acute and long‐term effect of olanzapine compared with placebo and haloperidol on serum prolactin concentrations. Schizophrenia Research 1997;26(1):41‐54. - PubMed
    1. Crawford AMK, Beasley CM, Tollefson GD. The acute and long‐term effect of olanzapine compared with placebo and haloperidol on serum prolactin concentration. Proceedings of the 10th European College of Neuropsychopharmacology Congress; 1997 Sep 13‐17; Vienna, Austria. 1997. - PubMed
    1. Crawford AMK, Gomez JC, Beasley CM Jr, Tollefson GD. Olanzapine versus haloperidol: analysis of schizophrenic patients from the multi‐center international trial. European Neuropsychopharmacology 1997;7:2.015. - PubMed
Csernansky 1999 {published data only}
    1. Csernansky J. Do novel antipsychotics optimize long term outcomes in schizophrenia. International Journal of Neuropsychopharmacology 2000;3(Suppl 1):S1.
    1. Csernansky J, Brecher M, Okamoto A. Risperidone vs haloperidol: relapse prevention in schizophrenia and schizoaffective disorders: a long‐term double‐blind comparison. Proceedings of the 11th World Congress of Psychiatry; 1999 Aug 6‐11; Hamburg, Germany. 1999.
    1. Csernansky J, Okamoto A. A long term double blind comparison of risperidone and haloperidol in stable outpatients with schizophrenia or schizoaffective disorder. International Journal of Neuropsychopharmacology 2000;3(Suppl 1):S155.
    1. Csernansky J, Okamoto A. Risperidone versus haloperidol for prevention of relapse in schizophrenia and schizoaffective disorders: long term double blind comparison. Proceedings of the 22nd Collegium Internationale Neuro‐Psychopharmacologicum Congress; 2000 Jul 9‐13; Brussels, Belgium. 2000.
    1. Csernansky J, Okamoto A. Risperidone versus haloperidol for prevention of relapse in schizophrenia and schizoaffective disorders: long term double blind comparison. Schizophrenia Research 2000;41(1):198.
David 2000 {published data only}
    1. David S, Crawford AM, Breier A. Prolactin levels in olanzapine versus typical and atypical antipsychotics. European Neuropsychopharmacology 1998;8(Suppl 2):s229.
    1. David SR, Meehan KM, Sutton VK, Taylor CC. Treatment of negative symptoms with olanzapine in comparison with other novel antipsychotic agents. European Neuropsychopharmacology 1999;9:S292.
    1. David SR, Taylor CC, Kinon BJ, Breier A. The effects of olanzapine, risperidone, and haloperidol on plasma prolactin levels in patients with schizophrenia. Clinical Therapeutics 2000;22(9):1085‐96. - PubMed
Davis 2001 {published data only}
    1. Davis JM, Chen N. Evidence of efficacy of risperidone in schizophrenia. Schizophrenia Research 2001;49(1‐2):224‐5.
    1. Davis SM, Koch GG, Davis CE, Vange LM. Statistical approaches to effectiveness measurement and outcome‐driven re‐randomizations in the clinical antipsychotic trials of intervention effectiveness (CATIE) studies. Schizophrenia Bulletin 2003;29(1):73‐80. - PubMed
Dossenbach 1997 {published data only}
    1. Dossenbach M, Friedel P, Jakovljevic M, Hotujac L, Folnegovic V, Uglesic B, et al. Olanzapine versus fluphenazine ‐ six weeks' treatment of acute schizophrenia. Proceedings of the 10th European College of Neuropsychopharmacology Congress; 1997 Sep 13‐17; Vienna, Austria. 1997.
    1. Dossenbach M, Jakovljevic M, Folnegovic F, Uglesic B, Dodig G, Friedel P, et al. Olanzapine versus fluphenazine ‐ 6 weeks treatment of anxiety symptoms during acute schizophrenia. Schizophrenia Research 1998;29(1,2):203.
Dubitsky 2002 {published data only}
    1. Dubitsky GM, Harris R, Laughren T, Hardeman S. Abilify (aripiprazole) tablets; medical review part 1. www.fda.gov/cder/foi/nda/2002/21‐436_Abilify.htm 2002 (accessed 9 October 2013):1‐50.
    1. Dubitsky GM, Harris R, Laughren T, Hardeman S. Abilify (aripiprazole) tablets; medical review part 2. www.fda.gov/cder/foi/nda/2002/21‐436_Abilify.htm. U.S. Food and Drug Administration CDER, 2002 (accessed 9 October 2013):50‐110.
    1. Dubitsky GM, Harris R, Laughren T, Hardeman S. Abilify (aripiprazole) tablets; medical review part 3. www.fda.gov/cder/foi/nda/2002/21‐436_Abilify.htm. U.S. Food and Drug Administration CDER, 2002 (accessed 9 October 2013):111‐75.
    1. Dubitsky GM, Harris R, Laughren T, Hardeman S. Abilify (aripiprazole) tablets; medical review part 4. www.fda.gov/cder/foi/nda/2002/21‐436_Abilify.htm. U.S. Food and Drug Administration CDER, 2002 (accessed 9 October 2013):176‐232.
Edgell 2000 {published data only}
    1. Edgell ET, Andersen SW, Grainger D, Wang J. Resource use and quality of life of olanzapine compared with risperidone: results from an international randomized clinical trial. Proceedings of the 21st Collegium Internationale Neuro‐Psychopharmacologicum Congress; 1998 Jul 12‐16; Glasgow, UK. 1998.
    1. Edgell ET, Andersen SW, Johnstone BM, Dulisse B, Revicki D, Breier A. Olanzapine versus risperidone: a prospective comparison of clinical and economic outcomes in schizophrenia. International Journal of Neuropsychopharmacology 2000;3(Suppl 1):S92. - PubMed
    1. Edgell ET, Andersen SW, Johnstone BM, Dulisse B, Revicki D, Breier A. Olanzapine versus risperidone: a prospective comparison of clinical and economic outcomes in schizophrenia. Pharmacoeconomics 2000;18(6):567‐79. - PubMed
    1. Edgell ET, Andersen SW, Johnstone BM, Dulisse B, Revicki D, Breier A, et al. Olanzapine versus risperidone: a prospective comparison of clinical and economic outcomes in schizophrenia. European Psychiatry 2000;15(Suppl 2):408s. - PubMed
    1. Edgell ET, Grainger DL, Andersen SW, Wang J. Resource use and quality of life associated with olanzapine compared with risperidone. Proceedings of the 151st Annual Meeting of the American Psychiatric Association; 1998 May 30‐Jun 4; Toronto, Ontario, Canada. 1998.
Fleming 2007a {published data only}
    1. Fleming K, Potkin SG, Binneman B, Keller D, Alphs L, Panagides J. Effects of asenapine on cognitive function in acute schizophrenia: a placebo‐ and risperidone‐controlled trial. European Neuropsychopharmacology 2007;17(Suppl 4):S466.
Friedman 2000 {published data only}
    1. Friedman J, Adler D, Temporini H, Harvey P, Kemether E, Davis K. Alpha2 agonists enhance cognition of schizophrenia patients in combination with atypical but not typical neuroleptics. International Journal of Neuropsychopharmacology 2000;3(Suppl 1):S155.
    1. Friedman JI, Adler D, Temporini HD, Harvey PD, Kemether EM, Davis KL. Alpha‐2 agonists enhance cognition of schizophrenia patients in combination with atypical but not typical neuroleptics. Proceedings of the 155th Annual Meeting of the American Psychiatric Association; 2002 May 18‐23; Philadelphia, Pennsylvania, USA. 2002.
    1. Friedman JI, Adler DN, Howanitz E, Harvey PD, Brenner G, Temporini H, et al. A double blind placebo controlled trial of donepezil adjunctive treatment to risperidone for the cognitive impairment of schizophrenia. Biological Psychiatry 2002;51:349‐57. - PubMed
    1. Friedman JI, Adler DN, Howanitz E, Harvey PD, Brenner G, Temporini H, et al. A double blind placebo controlled trial of donepezil adjunctive treatment to risperidone for the cognitive impairment of schizophrenia. Schizophrenia Research 2002;53(3 Suppl 1):9. - PubMed
    1. Friedman JI, Adler DN, Howanitz E, Temporini H, Harvey PD, Davis KL. Effects of donepezil on cognition, symptoms, and movement disorders in patients with chronic schizophrenia. Proceedings of the 39th Annual Meeting of the American College of Neuropsychopharmacology; 2000 Dec 10‐14; San Juan, Puerto Rico. 2000.
Gismondi 2004 {published data only}
    1. Gismondi R, Meltzer H, Kujawa M, Carson W, Stringfellow J, Iwamoto T, et al. Aripiprazole versus perphenazine in treatment‐resistant schizophrenia. Proceedings of the XXIVth Collegium Internationale Neuro‐Psychopharmacologicum Congress; 2004 June 20–24, Paris, France 2004.
Gregor 2000 {published data only}
    1. Gregor K, Hamilton S, Edgell E. Functional outcomes in schizophrenia: a European comparison of olanzapine and haloperidol. Proceedings of the 11th World Congress of Psychiatry; 1999 Aug 6‐11; Hamburg, Germany. 1999.
    1. Gregor KJ, Allicar MP, Lilliu H, Olivier V, Pen C, Gavart S. An economic comparison of olanzapine versus haloperidol in the treatment of schizophrenia in France. International Journal of Neuropsychopharmacology 2000;3(Suppl 1):S161.
    1. Gregor KJ, Hamilton SH, Edgell ET. Functional outcomes in schizophrenia: a European comparison of olanzapine and haloperidol. European Neuropsychopharmacology 1999;9(Suppl 1):S11.
    1. Gregor KJ, Hamilton SH, Edgell ET. Functional outcomes in schizophrenia: a European comparison of olanzapine and haloperidol. European Neuropsychopharmacology 1999;9:S289. - PubMed
    1. Gregor KJ, Hamilton SH, Edgell ET. Functional outcomes in schizophrenia: a European comparison of olanzapine and haloperidol. Schizophrenia Research 2000;41(1):189. - PubMed
Harvey 2001 {published data only}
    1. Harvey K, Burns T, Sedgwick P, Higgitt A, Creed F, Fahy T. Relatives of patients with severe psychotic disorders: factors that influence contact frequency. Report from the UK700 trial. British Journal of Psychiatry 2001;178:248‐54. - PubMed
    1. Harvey P, Meltzer H, Green M. Long term cognitive effects of risperidone treatment in schizophrenia. International Journal of Neuropsychopharmacology 2000;3(Suppl 1):S154.
    1. Harvey P, Meltzer H, Green M. Risperidone cognitive effects in schizophrenia and schizoaffective patients. International Drug Therapy Newsletter 2001;36(8):59.
    1. Harvey P, Meltzer HY, Green MP. Cognitive effects of risperidone versus olanzapine in patients with schizophrenia or schizoaffective disorder. Proceedings of the 7th World Congress of Biological Psychiatry; 2001 Jul 1‐6; Berlin, Germany. 2001.
    1. Harvey P, Melzer H, Green M. Cognitive effects of risperidone and olanzapine in patients with schizophrenia or schizoaffective disorder. Biological Psychiatry 2001;49(8):123S.
Hwang 2003 {published data only}
    1. Hwang TJ, Lee S‐M, Sun HJ, Lin H‐N, Tsai S‐J, Lee Y‐C, et al. Amisulpride versus risperidone in the treatment of schizophrenic patients: a double‐blind pilot study in Taiwan. Journal of the Formosan Medical Association 2003;102(1):30‐6. - PubMed
Hwang 2005 {published data only}
    1. Hwang TJ, Chan HY, Lin WW, Lin SK, Hwu HG, Cheng MY, et al. Aripiprazole versus risperidone in the treatment of acutely relapsed patients with schizophrenia in Taiwan: a randomized controlled trial. European Neuropsychopharmacology 2005;15(Suppl 3):S497.
Kane 2005 {published data only}
    1. Kane J, Carson Wh, Kujawa M, Stringfellow J, Marcus R, Sanchez R, et al. Aripiprazole in treatment‐resistant schizophrenia: a 6‐week double‐blind comparison study versus perphenazine. Schizophrenia Research 2004;67(1):155‐6.
    1. Kane J, Eerdekens M, Keith S, Lesem M, Karcher K, Lindenmayer J‐P. Efficacy and safety of Risperdal Consta, a long‐acting injection risperidone formulation RIS‐USA‐121. Promotional slides on file from Janssen‐Cilag UK Ltd 2002.
    1. Kane J, Eerdekens M, Keith S, Lesem M, Karcher K, Lindenmayer J‐P. Efficacy and safety of a novel long‐acting risperidone formulation. European Psychiatry 2002;17(Suppl 1):S193. - PubMed
    1. Kane J, Eerdekens M, Keith S, Lesem M, Karcher K, Lindenmayer J‐P. Efficacy and safety of a novel long‐acting risperidone microspheres formulation. Proceedings of the 11th Biennial Winter Workshop on Schizophrenia; 2002 Feb 24‐Mar 1; Davos, Switzerland. 2002.
    1. Kane J, Eerdekens M, Keith S, Lesem M, Karcher K, Lindenmayer JP. Long‐acting risperidone microspheres for treatment of patients with schizophrenia. European Neuropsychopharmacology 2001;11(3):291.
Kinon 1998 {published data only}
    1. Kinon B, Basson B, Malcolm S, Breier A. Strategies for switching from conventional antipsychotic drugs or risperidone to olanzapine. Proceedings of the 39th Annual Meeting of the New Clinical Drug Evaluation Unit; 1999 Jun 1‐4; Boca Raton, Florida, USA. 1999. - PubMed
    1. Kinon B, Basson B, Tollefson GD. Gender‐specific prolactin olanzapine versus haloperidol in schizophrenia. 151st Annual Meeting of the American Psychiatric Association; 1998 May 30‐Jun 4; Toronto, Ontario, Canada. 1998. [151st Annual Meeting of the American Psychiatric Association [CD‐ROM]: MARATHON Multimedia, 1988 NR449; 151st Annual Meeting of the American Psychiatric Association [CD‐ROM]: MARATHON Multimedia, 1988 NR739]
    1. Kinon B, Basson B, Tollefson GD. Gender‐specific prolactin olanzapine versus haloperidol in schizophrenia. Proceedings of the 151st Annual Meeting of the American Psychiatric Association; 1998 May 30‐Jun 4; Toronto, Ontario, Canada. 1998.
    1. Kinon B, Basson BR, Malcolm SK, Tollefson G. Strategies for switching from conventional antipsychotic drugs to olanzapine. Proceedings of the 152nd Annual Meeting of the American Psychiatric Association; 1999 May 15‐20; Washington, DC, USA. 1999.
    1. Kinon B, Breier A, Malcolm S, Basson B. Strategies for switching from conventional antipsychotic drugs or risperidone to olanzapine. Proceedings of the 11th World Congress of Psychiatry; 1999 Aug 6‐11; Hamburg, Germany. 1999. - PubMed
Kinon 2015 {published data only}
    1. Kinon BJ, Millen BA, Zhang L, McKinzie DL. Exploratory analysis for a targeted patient population responsive to the metabotropic glutamate 2/3 receptor agonist pomaglumetad methionil in schizophrenia. Biological psychiatry 2015;InPress:InPress. - PubMed
Lauriello 2005 {published data only}
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Lemmens 1994 {published data only}
    1. Lemmens P, Smedt G, Gheuens J, Tritsmans L. Efficacy of risperidone in the treatment of schizophrenia. Proceedings of the 7th Biennial Winter Workshop on Schizophrenia; 1994 Jan 23‐28; Les Diablerets, Switzerland 1994; Vol. 11, issue 2:106.
Lieberman 2005 {published data only}
    1. Lieberman J, McEnvoy J, Stroup S. Protocol: comparative effectiveness of antipsychotic medications in patients with schizophrenia: revised in response to DSMB comments. National Institute of Mental Health. Chapel Hill, USA: University of North Carolina, 2000.
    1. Lieberman J, McEvoy J, Stroup S. Trial design summary: Comparative effectiveness of antipsychotic medications in patients with schizophrenia: Draft. National Institute of Mental Health. Chapel Hill, USA: University of North Carolina, 2002.
    1. Lieberman J, McEvoy JP, Perkins D, Hamer RH. Comparison of atypicals in first‐episode psychosis: a randomized, 52‐week comparison of olanzapine, quetiapine, and risperidone. European Neuropsychopharmacology 2005;15(Suppl 3):S525.
    1. Lieberman JA. Comparative effectiveness of antipsychotic medications in patients with schizophrenia (CATIE schizophrenia trial). clinicaltrials.gov/ct2/show/NCT00014001 2001 (accessed 9 October 2013).
    1. Lieberman JA. Research gaps and current research initiatives to improve the treatment of schizophrenia. Proceedings of the 156th Annual Meeting of the American Psychiatric Association; 2003 May 17‐22; San Francisco, California, USA. 2003.
Lindstrom 1994 {published data only}
    1. Lindstrom E, Knorring L. Changes in single symptoms and separate factors of the schizophrenic syndrome after treatment with risperidone or haloperidol. Pharmacopsychiatry 1994;27(3):108‐13. - PubMed
Loo 1997 {published data only}
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Lopez 1996 {published data only}
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Lopez‐Ibor 1992 {published data only}
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Marder 1991 {published data only}
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McClure 2009 {published data only}
    1. McClure MM, Koenigsberg HW, Reynolds D, Goodman M, New A, Trestman R, Silverman J, Harvey PD, Siever LJ. The effects of risperidone on the cognitive performance of individuals with schizotypal personality disorder. Journal of clinical psychopharmacology 2009;29:396‐398. - PMC - PubMed
McKenna 2004 {published data only}
    1. McKenna PJ. An international study of improving treatment for the most severely ill with schizophrenia. National Research Register 2004.
Nasrallah 2004a {published data only}
    1. Nasrallah HA, Duchesne I, Mehnert A, Janagap C, Eerdekens M. Correction. Journal of Clinical Psychiatry [linchuang jingshen yixue zazhi] [临床精神医学杂志] 2004;65(8):1150. - PubMed
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NCT00034892 {published data only}
    1. NCT00034892. Efficacy and tolerability of olanzapine, quetiapine and risperidone in the treatment of first episode psychosis: a randomized double blind 52‐week comparison. clinicaltrials.gov/ct2/show/NCT00034892 (2002) (accessed 9 October 2013).
NCT00088075 {published data only}
    1. NCT00088075. A randomized, double‐blind, placebo‐controlled clinical study of the efficacy and safety of risperidone for the treatment of schizophrenia in adolescents. clinicaltrials.gov/ct2/show/NCT00088075 (2004) (accessed 9 October 2013).
NCT00202007 {published data only}
    1. NCT00202007. A multi‐center, randomized, double‐blind study, comparing with risperidone, to evaluate the efficacy and safety of aripiprazole in the treatment of patients with schizophrenia. clinicaltrials.gov/ct2/show/NCT00202007 (2005) (accessed 9 October 2013).
NCT00249119 {published data only}
    1. NCT00249119. Risperidone in the treatment of chronic schizophrenic patients: an international multicentre double‐blind parallel‐group comparative study versus haloperidol. clinicaltrials.gov/ct2/show/NCT00249119 (2005) (accessed 9 October 2013).
NCT00253136 {published data only}
    1. NCT00253136. Risperidone depot (microspheres) vs placebo in the treatment of subjects with schizophrenia. clinicaltrials.gov/ct2/show/NCT00253136 (2005) (accessed 9 October 2013).
NCT00305474 {published data only}
    1. NCT00305474. Identification and treatment of the liability to develop schizophrenia. clinicaltrials.gov/ct2/show/results/NCT00305474 (2006) (accessed 9 October 2013).
NCT 02109562 {published data only}
    1. Nct02109562. A Phase 3, Randomized, Double‐Blind, Placebo‐Controlled, Multicenter Study to Evaluate the Efficacy, Safety and Tolerability of RBP‐7000 (90mg and 120mg) as a Treatment in Subjects With Acute Schizophrenia Over 8 Weeks (2 Subcutaneous Doses). http://Clinicaltrials.gov/show/NCT02109562.
Peuskens 1995 {published data only}
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Peuskens 2001a {published data only}
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Rabinowitz 2001 {published data only}
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References to studies awaiting assessment

Anon 2010 {published data only}
    1. Anon. An assessment of the long‐term efficacy and safety of org 5222, risperidone and placebo in subjects with schizophrenia. http://www.clinicalstudyresults.org/ (2010).
Bose 2010a {published data only}
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Cavazzoni 2002 {published data only}
    1. Cavazzoni P, Berg P, Millikan M, Carlson C, Beasley C. An integrated analysis of treatment‐emergent extrapyramidal syndrome in schizophrenic patients during olanzapine clinical trials versus placebo, haloperidol, risperidone or clozapine. International Journal of Neuropsychopharmacology 2002;5(Suppl 1):S164.
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DeMartinis 2012 {published data only}
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GlaxoSmithKline 2006 {published data only}
    1. NCT00049946. A multicenter, double‐blind, double‐dummy, placebo‐controlled, randomized, parallel group evaluation of the efficacy and safety of a fixed‐dose of talnetant versus placebo versus risperidone in subjects with schizophrenia. clinicaltrials.gov/show/NCT00049946 (2002).
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Litman 2014 {published data only}
    1. Litman R, Smith M, Doherty J, Cross A, Raines S, Zukin S. AZD8529, a positive allosteric modulator at the MGGLUR2 receptor, does not improve symptoms in schizophrenia: A proof of principle study. European neuropsychopharmacology 2014;24:S508‐S509. - PubMed
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NCT 00694707 {published data only}
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NCT01086748 {published data only}
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NCT01175135 {published data only}
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NCT01363349 {published data only}
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Nisenbaum 2013 {published data only}
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Rujescu 2009 {published data only}
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Vanover 2014 {published data only}
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Xu 2009 {published data only}
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References to ongoing studies

NCT00174200 {published data only}
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