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Meta-Analysis
. 2013 Nov 5;2013(11):CD001949.
doi: 10.1002/14651858.CD001949.pub3.

Pimozide for schizophrenia or related psychoses

Meghana Mothi  1 , Stephanie Sampson
Affiliations
Meta-Analysis

Pimozide for schizophrenia or related psychoses

Meghana Mothi et al. Cochrane Database Syst Rev. .

Abstract

Background: Pimozide, formulated in the 1960s, continues to be marketed for the care of people with schizophrenia or related psychoses such as delusional disorder. It has been associated with cardiotoxicity and sudden unexplained death. Electrocardiogram monitoring is now required before and during use.

Objectives: To review the effects of pimozide for people with schizophrenia or related psychoses in comparison with placebo, no treatment or other antipsychotic medication.A secondary objective was to examine the effects of pimozide for people with delusional disorder.

Search methods: We searched the Cochrane Schizophrenia Group's Register (28 January 2013).

Selection criteria: We sought all relevant randomised clinical trials (RCTs) comparing pimozide with other treatments.

Data collection and analysis: Working independently, we inspected citations, ordered papers and then re-inspected and assessed the quality of the studies and of extracted data. For homogeneous dichotomous data, we calculated the relative risk (RR), the 95% confidence interval (CI) and mean differences (MDs) for continuous data. We excluded data if loss to follow-up was greater than 50%. We assessed risk of bias for included studies and used GRADE to rate the quality of the evidence.

Main results: We included 32 studies in total: Among the five studies that compared pimozide versus placebo, only one study provided data for global state relapse, for which no difference between groups was noted at medium term (1 RCT n = 20, RR 0.22 CI 0.03 to 1.78, very low quality of evidence). None of the five studies provided data for no improvement or first-rank symptoms in mental state. Data for extrapyramidal symptoms demonstrate no difference between groups for Parkinsonism (rigidity) at short term (1 RCT, n = 19, RR 5.50 CI 0.30 to 101.28, very low quality of evidence) or at medium term (1 RCT n = 25, RR 1.33 CI 0.14 to 12.82, very low quality of evidence), or for Parkinsonism (tremor) at medium term (1 RCT n = 25, RR 1 CI 0.2 to 4.95, very low quality of evidence). No data were reported for quality of life at medium term.Of the 26 studies comparing pimozide versus any antipsychotic, seven studies provided data for global state relapse at medium term, for which no difference was noted (7 RCTs n = 227, RR 0.82 CI 0.57 to 1.17, moderate quality of evidence). Data from one study demonstrated no difference in mental state (no improvement) at medium term (1 RCT n = 23, RR 1.09 CI 0.08 to 15.41, very low quality evidence); another study demonstrated no difference in the presence of first-rank symptoms at medium term (1 RCT n = 44, RR 0.53 CI 0.25 to 1.11, low quality of evidence). Data for extrapyramidal symptoms demonstrate no difference between groups for Parkinsonism (rigidity) at short term (6 RCTs n = 186, RR 1.21 CI 0.71 to 2.05,low quality of evidence) or medium term (5 RCTs n = 219, RR 1.12 CI 0.24 to 5.25,low quality of evidence), or for Parkinsonism (tremor) at medium term (4 RCTs n = 174, RR 1.46 CI 0.68 to 3.11, very low quality of evidence). No data were reported for quality of life at medium term.In the one study that compared pimozide plus any antipsychotic versus the same antipsychotic, significantly fewer relapses were noted in the augmented pimozide group at medium term (1 RCT n = 69, RR 0.28 CI 0.15 to 0.50, low quality evidence). No data were reported for mental state outcomes or for extrapyramidal symptoms (EPS). Data were skewed for quality of life scores, which were not included in the meta-analysis but were presented separately.Two studies compared pimozide plus any antipsychotics versus antipsychotic plus placebo; neither study reported data for outcomes of interest, apart from Parkinsonism at medium term and quality of life using the Specific Level of Functioning scale (SLOF); however, data were skewed.Only one study compared pimozide plus any antipsychotic versus antipsychotics plus antipsychotic; no data were reported for global state and mental state outcomes of interest. Data were provided for Parkinsonism (rigidity and tremor) using the Extrapyramidal Symptom Rating Scale (ESRS); however, these data were skewed.

Authors' conclusions: Although shortcomings in the data are evident, enough overall consistency over different outcomes and time scales is present to confirm that pimozide is a drug with efficacy similar to that of other, more commonly used antipsychotic drugs such as chlorpromazine for people with schizophrenia. No data support or refute its use for those with delusional disorder.

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Conflict of interest statement

None known.

Figures

1
1
Pimozide structure.
2
2
Funnel plot of comparison: 3 PIMOZIDE versus ANY ANTIPSYCHOTIC, outcome: 3.3 Global state: 2. No improvement.
3
3
Study flow diagram: combined from the 2002 initial review search; the 2005 first update search; and the current 2013 update search.
4
4
Risk of bias graph: review authors' judgements about each risk of bias item presented as percentages across all included studies.
5
5
Risk of bias summary: review authors' judgements about each risk of bias item for each included study.
6
6
Forest plot of comparison: 3 PIMOZIDE versus ANY ANTIPSYCHOTIC, outcome: 3.10 Adverse effects: 1. Extrapyramidal adverse effects ‐ specific.
1.1
1.1. Analysis
Comparison 1 PIMOZIDE versus PLACEBO, Outcome 1 Global state: 1. Relapse ‐ clinical diagnoses.
1.2
1.2. Analysis
Comparison 1 PIMOZIDE versus PLACEBO, Outcome 2 Global state: 2. No improvement.
1.3
1.3. Analysis
Comparison 1 PIMOZIDE versus PLACEBO, Outcome 3 Mental state: 1. Specific symptoms.
1.4
1.4. Analysis
Comparison 1 PIMOZIDE versus PLACEBO, Outcome 4 Adverse effects: 1. Extrapyramidal adverse effects.
1.5
1.5. Analysis
Comparison 1 PIMOZIDE versus PLACEBO, Outcome 5 Adverse effects: 2. Anticholinergic effects.
1.6
1.6. Analysis
Comparison 1 PIMOZIDE versus PLACEBO, Outcome 6 Adverse effects: 3. Cardiovascular effects.
1.7
1.7. Analysis
Comparison 1 PIMOZIDE versus PLACEBO, Outcome 7 Adverse effects: 4. Abnormal laboratory tests.
1.8
1.8. Analysis
Comparison 1 PIMOZIDE versus PLACEBO, Outcome 8 Adverse effects: 5. Central nervous system effects.
1.9
1.9. Analysis
Comparison 1 PIMOZIDE versus PLACEBO, Outcome 9 Adverse effects: 6. Dermatological effects.
1.10
1.10. Analysis
Comparison 1 PIMOZIDE versus PLACEBO, Outcome 10 Adverse effects: 7. Endocrine effects.
1.11
1.11. Analysis
Comparison 1 PIMOZIDE versus PLACEBO, Outcome 11 Adverse effects: 8. Gastrointestinal effects.
1.12
1.12. Analysis
Comparison 1 PIMOZIDE versus PLACEBO, Outcome 12 Adverse effects: 9. Other.
1.13
1.13. Analysis
Comparison 1 PIMOZIDE versus PLACEBO, Outcome 13 Leaving the study early: 1. Due to adverse effects.
1.14
1.14. Analysis
Comparison 1 PIMOZIDE versus PLACEBO, Outcome 14 Leaving the study early: 2. Any reason.
2.1
2.1. Analysis
Comparison 2 PIMOZIDE versus PLACEBO: withdrawal study, Outcome 1 Global state: 1. Relapse ‐ clinical diagnoses.
2.2
2.2. Analysis
Comparison 2 PIMOZIDE versus PLACEBO: withdrawal study, Outcome 2 Mental state: 1. Use of additional medication.
2.3
2.3. Analysis
Comparison 2 PIMOZIDE versus PLACEBO: withdrawal study, Outcome 3 Adverse effects: 1. Death.
2.4
2.4. Analysis
Comparison 2 PIMOZIDE versus PLACEBO: withdrawal study, Outcome 4 Leaving the study early: 1. Any reason.
3.1
3.1. Analysis
Comparison 3 PIMOZIDE versus ANY ANTIPSYCHOTIC, Outcome 1 Service utilisation: 1. Hospital admission.
3.2
3.2. Analysis
Comparison 3 PIMOZIDE versus ANY ANTIPSYCHOTIC, Outcome 2 Global state: 1. Relapse ‐ clinical diagnoses.
3.3
3.3. Analysis
Comparison 3 PIMOZIDE versus ANY ANTIPSYCHOTIC, Outcome 3 Global state: 2. No improvement.
3.4
3.4. Analysis
Comparison 3 PIMOZIDE versus ANY ANTIPSYCHOTIC, Outcome 4 Global state: 3. Average score ‐ CGI (high = poor).
3.5
3.5. Analysis
Comparison 3 PIMOZIDE versus ANY ANTIPSYCHOTIC, Outcome 5 Mental state: 1. Average score ‐ BPRS (high = poor).
3.7
3.7. Analysis
Comparison 3 PIMOZIDE versus ANY ANTIPSYCHOTIC, Outcome 7 Mental state: 3. No improvement.
3.8
3.8. Analysis
Comparison 3 PIMOZIDE versus ANY ANTIPSYCHOTIC, Outcome 8 Mental state: 4. Specific symptoms.
3.9
3.9. Analysis
Comparison 3 PIMOZIDE versus ANY ANTIPSYCHOTIC, Outcome 9 Mental state: 5. Use of additional medication.
3.10
3.10. Analysis
Comparison 3 PIMOZIDE versus ANY ANTIPSYCHOTIC, Outcome 10 Adverse effects: 1. Extrapyramidal adverse effects ‐ specific.
3.12
3.12. Analysis
Comparison 3 PIMOZIDE versus ANY ANTIPSYCHOTIC, Outcome 12 Adverse effects: 3. Death.
3.13
3.13. Analysis
Comparison 3 PIMOZIDE versus ANY ANTIPSYCHOTIC, Outcome 13 Adverse effects: 4. Anticholinergic effects.
3.14
3.14. Analysis
Comparison 3 PIMOZIDE versus ANY ANTIPSYCHOTIC, Outcome 14 Adverse effects: 5. Cardio‐vascular effects.
3.15
3.15. Analysis
Comparison 3 PIMOZIDE versus ANY ANTIPSYCHOTIC, Outcome 15 Adverse effects: 6. Abnormal laboratory tests.
3.16
3.16. Analysis
Comparison 3 PIMOZIDE versus ANY ANTIPSYCHOTIC, Outcome 16 Adverse effects: 7. Central nervous system effects.
3.17
3.17. Analysis
Comparison 3 PIMOZIDE versus ANY ANTIPSYCHOTIC, Outcome 17 Adverse effects: 8. Dermatological effects.
3.18
3.18. Analysis
Comparison 3 PIMOZIDE versus ANY ANTIPSYCHOTIC, Outcome 18 Adverse effects: 9. Endocrine effects.
3.19
3.19. Analysis
Comparison 3 PIMOZIDE versus ANY ANTIPSYCHOTIC, Outcome 19 Adverse effects: 10. Gastrointestinal effects.
3.20
3.20. Analysis
Comparison 3 PIMOZIDE versus ANY ANTIPSYCHOTIC, Outcome 20 Adverse effects: 11. Genitourinary effects.
3.21
3.21. Analysis
Comparison 3 PIMOZIDE versus ANY ANTIPSYCHOTIC, Outcome 21 Adverse effects: 12. Other.
3.23
3.23. Analysis
Comparison 3 PIMOZIDE versus ANY ANTIPSYCHOTIC, Outcome 23 Leaving the study early: 1. Due to relapse.
3.24
3.24. Analysis
Comparison 3 PIMOZIDE versus ANY ANTIPSYCHOTIC, Outcome 24 Leaving the study early: 2. Due to adverse effects.
3.25
3.25. Analysis
Comparison 3 PIMOZIDE versus ANY ANTIPSYCHOTIC, Outcome 25 Leaving the study early: 3. Any reason.
4.1
4.1. Analysis
Comparison 4 PIMOZIDE + ANY ANTIPSYCHOTIC versus ANY ANTIPSYCHOTIC, Outcome 1 Global state: 1. Relapse ‐ clinical diagnoses.
4.2
4.2. Analysis
Comparison 4 PIMOZIDE + ANY ANTIPSYCHOTIC versus ANY ANTIPSYCHOTIC, Outcome 2 Leaving the study early: 1. Any reason.
5.2
5.2. Analysis
Comparison 5 PIMOZIDE + ANY ANTIPSYCHOTIC versus ANY ANTIPSYCHOTIC + PLACEBO, Outcome 2 Global state: 2. Average score ‐ CGI‐S (high = poor).
5.3
5.3. Analysis
Comparison 5 PIMOZIDE + ANY ANTIPSYCHOTIC versus ANY ANTIPSYCHOTIC + PLACEBO, Outcome 3 Global state: 3. Average score ‐ CGI‐I (high = poor).
5.4
5.4. Analysis
Comparison 5 PIMOZIDE + ANY ANTIPSYCHOTIC versus ANY ANTIPSYCHOTIC + PLACEBO, Outcome 4 Mental state: 1. Average score ‐ BPRS (high = poor).
5.5
5.5. Analysis
Comparison 5 PIMOZIDE + ANY ANTIPSYCHOTIC versus ANY ANTIPSYCHOTIC + PLACEBO, Outcome 5 Mental state: 2. Average score ‐ BPRS psychosis subscale (high = poor).
5.7
5.7. Analysis
Comparison 5 PIMOZIDE + ANY ANTIPSYCHOTIC versus ANY ANTIPSYCHOTIC + PLACEBO, Outcome 7 Mental state: 4. Average score ‐ SANS (high = poor).
5.8
5.8. Analysis
Comparison 5 PIMOZIDE + ANY ANTIPSYCHOTIC versus ANY ANTIPSYCHOTIC + PLACEBO, Outcome 8 Adverse effects: 1. Extrapyramidal adverse effects ‐ specific.
5.10
5.10. Analysis
Comparison 5 PIMOZIDE + ANY ANTIPSYCHOTIC versus ANY ANTIPSYCHOTIC + PLACEBO, Outcome 10 Adverse effects: 3. Cardiovascular effects.
5.11
5.11. Analysis
Comparison 5 PIMOZIDE + ANY ANTIPSYCHOTIC versus ANY ANTIPSYCHOTIC + PLACEBO, Outcome 11 Adverse effects: 4. Cardiovascular effects ‐ average score (high = poor).
5.14
5.14. Analysis
Comparison 5 PIMOZIDE + ANY ANTIPSYCHOTIC versus ANY ANTIPSYCHOTIC + PLACEBO, Outcome 14 Adverse effects: 7. Other.
5.16
5.16. Analysis
Comparison 5 PIMOZIDE + ANY ANTIPSYCHOTIC versus ANY ANTIPSYCHOTIC + PLACEBO, Outcome 16 Leaving the study early: 1. Due to adverse effects.
5.17
5.17. Analysis
Comparison 5 PIMOZIDE + ANY ANTIPSYCHOTIC versus ANY ANTIPSYCHOTIC + PLACEBO, Outcome 17 Leaving the study early: 2. Any reason.
6.1
6.1. Analysis
Comparison 6 PIMOZIDE + ANY ANTIPSYCHOTIC versus ANY ANTIPSYCHOTIC + ANY ANTIPSYCHOTIC, Outcome 1 Global state: 1. No improvement.
6.2
6.2. Analysis
Comparison 6 PIMOZIDE + ANY ANTIPSYCHOTIC versus ANY ANTIPSYCHOTIC + ANY ANTIPSYCHOTIC, Outcome 2 Global state: 2. Average score ‐ CGI‐S (high = poor).
6.3
6.3. Analysis
Comparison 6 PIMOZIDE + ANY ANTIPSYCHOTIC versus ANY ANTIPSYCHOTIC + ANY ANTIPSYCHOTIC, Outcome 3 Global state: 3. Average score ‐ CGI‐I (high = poor).
6.4
6.4. Analysis
Comparison 6 PIMOZIDE + ANY ANTIPSYCHOTIC versus ANY ANTIPSYCHOTIC + ANY ANTIPSYCHOTIC, Outcome 4 Mental state: 1. Average score ‐ SANS (high = poor).
6.13
6.13. Analysis
Comparison 6 PIMOZIDE + ANY ANTIPSYCHOTIC versus ANY ANTIPSYCHOTIC + ANY ANTIPSYCHOTIC, Outcome 13 Adverse effects: 8. Gastrointestinal effects.
6.14
6.14. Analysis
Comparison 6 PIMOZIDE + ANY ANTIPSYCHOTIC versus ANY ANTIPSYCHOTIC + ANY ANTIPSYCHOTIC, Outcome 14 Adverse effects: 9. Other.
6.16
6.16. Analysis
Comparison 6 PIMOZIDE + ANY ANTIPSYCHOTIC versus ANY ANTIPSYCHOTIC + ANY ANTIPSYCHOTIC, Outcome 16 Leaving the study early: 1. Due to adverse effects.
6.17
6.17. Analysis
Comparison 6 PIMOZIDE + ANY ANTIPSYCHOTIC versus ANY ANTIPSYCHOTIC + ANY ANTIPSYCHOTIC, Outcome 17 Leaving the study early: 2. Any reason.
7.1
7.1. Analysis
Comparison 7 Sensitivity Analysis: PIMOZIDE vs ANY ANTIPSYCHOTIC ‐ 1. risk of bias, Outcome 1 Mental state: 1. No improvement.
7.2
7.2. Analysis
Comparison 7 Sensitivity Analysis: PIMOZIDE vs ANY ANTIPSYCHOTIC ‐ 1. risk of bias, Outcome 2 Extrapyramidal adverse effects: 1. Specific ‐ Parkinsonism.
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Cetin 2000 {published data only}
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Cheadle 1979 {published data only}
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Chouinard 1979 {published data only}
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Clark 1971 {published data only}
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Crow 1986 {published data only}
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d'Elia 1974 {published data only}
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Feinberg 1988 {published data only}
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Friedman 1997 {published data only}
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Frussa Filho 1988 {published data only}
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Garton 1979 {published data only}
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Gomez Perez 1994 {published data only}
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Hass 1982 {published data only}
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Holl 1992 {published data only}
    1. Holl R. Nebenwirkungen von neuroleptika. Nervenheeikunde 1992;11:138‐41.
Huber 1983 {published data only}
    1. Huber G. Long‐term treatment of schizophrenia [Langzeitherapie der schizophrenie]. Medizinische Klinik 1983;78:604‐11.
Ibarra 1996 {published data only}
    1. Ibarra HS, Concha SJ, Coronel AR, Cruz PR, Alarcon NA. Pimozide in the treatment of delusional disorder. Proceedings of the 10th World Congress of Psychiatry; 1996 Aug 23‐28; Madrid, Spain. 1996.
Johnstone 1997 {published data only}
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Kenway 1971 {published data only}
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Konig 1971 {published data only}
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Krumholz 1970 {published data only}
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Lapierre 1976 {published data only}
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Lehmann 1970 {published data only}
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Mahal 1975 {published data only}
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Marshall 1971 {published data only}
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Masiak 1976 {published data only}
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McCoy 1992 {published data only}
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McCreadie 1978 {published data only}
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McCreadie 1983 {published data only}
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Meltzer 1986 {published data only}
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Moller 1994 {published data only}
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Sugerman 1971 {published data only}
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References to studies awaiting assessment

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References to other published versions of this review

Rathbone 2007
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