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Meta-Analysis
. 2020 Aug 11;8(8):CD008016.
doi: 10.1002/14651858.CD008016.pub3.

Maintenance treatment with antipsychotic drugs for schizophrenia

Anna Ceraso #  1 , Jessie Jingxia Lin #  2 , Johannes Schneider-Thoma  3 , Spyridon Siafis  3 , Magdolna Tardy  4 , Katja Komossa  5 , Stephan Heres  6 , Werner Kissling  3 , John M Davis  7 , Stefan Leucht  8
Affiliations
Meta-Analysis

Maintenance treatment with antipsychotic drugs for schizophrenia

Anna Ceraso et al. Cochrane Database Syst Rev. .

Abstract

Background: The symptoms and signs of schizophrenia have been linked to high levels of dopamine in specific areas of the brain (limbic system). Antipsychotic drugs block the transmission of dopamine in the brain and reduce the acute symptoms of the disorder. An original version of the current review, published in 2012, examined whether antipsychotic drugs are also effective for relapse prevention. This is the updated version of the aforesaid review.

Objectives: To review the effects of maintaining antipsychotic drugs for people with schizophrenia compared to withdrawing these agents.

Search methods: We searched the Cochrane Schizophrenia Group's Study-Based Register of Trials including the registries of clinical trials (12 November 2008, 10 October 2017, 3 July 2018, 11 September 2019).

Selection criteria: We included all randomised trials comparing maintenance treatment with antipsychotic drugs and placebo for people with schizophrenia or schizophrenia-like psychoses.

Data collection and analysis: We extracted data independently. For dichotomous data we calculated risk ratios (RR) and their 95% confidence intervals (CIs) on an intention-to-treat basis based on a random-effects model. For continuous data, we calculated mean differences (MD) or standardised mean differences (SMD), again based on a random-effects model.

Main results: The review currently includes 75 randomised controlled trials (RCTs) involving 9145 participants comparing antipsychotic medication with placebo. The trials were published from 1959 to 2017 and their size ranged between 14 and 420 participants. In many studies the methods of randomisation, allocation and blinding were poorly reported. However, restricting the analysis to studies at low risk of bias gave similar results. Although this and other potential sources of bias limited the overall quality, the efficacy of antipsychotic drugs for maintenance treatment in schizophrenia was clear. Antipsychotic drugs were more effective than placebo in preventing relapse at seven to 12 months (primary outcome; drug 24% versus placebo 61%, 30 RCTs, n = 4249, RR 0.38, 95% CI 0.32 to 0.45, number needed to treat for an additional beneficial outcome (NNTB) 3, 95% CI 2 to 3; high-certainty evidence). Hospitalisation was also reduced, however, the baseline risk was lower (drug 7% versus placebo 18%, 21 RCTs, n = 3558, RR 0.43, 95% CI 0.32 to 0.57, NNTB 8, 95% CI 6 to 14; high-certainty evidence). More participants in the placebo group than in the antipsychotic drug group left the studies early due to any reason (at seven to 12 months: drug 36% versus placebo 62%, 24 RCTs, n = 3951, RR 0.56, 95% CI 0.48 to 0.65, NNTB 4, 95% CI 3 to 5; high-certainty evidence) and due to inefficacy of treatment (at seven to 12 months: drug 18% versus placebo 46%, 24 RCTs, n = 3951, RR 0.37, 95% CI 0.31 to 0.44, NNTB 3, 95% CI 3 to 4). Quality of life might be better in drug-treated participants (7 RCTs, n = 1573 SMD -0.32, 95% CI to -0.57 to -0.07; low-certainty evidence); probably the same for social functioning (15 RCTs, n = 3588, SMD -0.43, 95% CI -0.53 to -0.34; moderate-certainty evidence). Underpowered data revealed no evidence of a difference between groups for the outcome 'Death due to suicide' (drug 0.04% versus placebo 0.1%, 19 RCTs, n = 4634, RR 0.60, 95% CI 0.12 to 2.97,low-certainty evidence) and for the number of participants in employment (at 9 to 15 months, drug 39% versus placebo 34%, 3 RCTs, n = 593, RR 1.08, 95% CI 0.82 to 1.41, low certainty evidence). Antipsychotic drugs (as a group and irrespective of duration) were associated with more participants experiencing movement disorders (e.g. at least one movement disorder: drug 14% versus placebo 8%, 29 RCTs, n = 5276, RR 1.52, 95% CI 1.25 to 1.85, number needed to treat for an additional harmful outcome (NNTH) 20, 95% CI 14 to 50), sedation (drug 8% versus placebo 5%, 18 RCTs, n = 4078, RR 1.52, 95% CI 1.24 to 1.86, NNTH 50, 95% CI not significant), and weight gain (drug 9% versus placebo 6%, 19 RCTs, n = 4767, RR 1.69, 95% CI 1.21 to 2.35, NNTH 25, 95% CI 20 to 50).

Authors' conclusions: For people with schizophrenia, the evidence suggests that maintenance on antipsychotic drugs prevents relapse to a much greater extent than placebo for approximately up to two years of follow-up. This effect must be weighed against the adverse effects of antipsychotic drugs. Future studies should better clarify the long-term morbidity and mortality associated with these drugs.

Trial registration: ClinicalTrials.gov NCT00111189 NCT00658645 NCT00704509.

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Conflict of interest statement

Anna Ceraso: none to declare. Jessie Lin: none to declare. Johannes Schneider‐Thoma: none to declare. Spyridon Siafis: none to declare. Magdolna Tardy: none to declare. Katja Komossa: none to declare. Stephan Heres: received speaker honoraria from Janssen‐Cilag, Eli Lilly, Sanofi‐Aventis, Otsuka, Lundbeck and Johnson & Johnson; accepted travel or hospitality payment from Janssen‐Cilag, Sanofi‐Aventis, Johnson & Johnson, Pfizer, Bristol‐Myers‐Squibb, AstraZeneca, Lundbeck, Novartis and Eli Lilly; participated in clinical trials sponsored or supported by Eli Lilly, Janssen Cilag, Johnson & Johnson, Bristol‐Myers‐Squibb, AstraZeneca, Lundbeck, Novartis, Servier, Pierre Fabre, Pfizer, Organon, Roche and Merck; and received honoraria for participation in advisory‐boards or activities as a consultant from Lundbeck, Otsuka, Eli Lilly, Roche, Teva, Janssen and Johnson & Johnson. Werner Kissling: has received honoraria for board memberships, consulting and lectures from Janssen and Eli Lilly; honoraria for development of educational materials from Janssen; grant support from Janssen and AstraZeneca; and travel/accommodation expenses from AstraZeneca, Eli Lilly and Janssen. John M Davis: none to declare. Stefan Leucht: In the last three years Stefan Leucht has received honoraria for lectures or consulting from LB Pharma, Otsuka, Lundbeck, Boehringer Ingelheim, LTS Lohmann, Janssen, Johnson&Johnson, TEVA, MSD, Sandoz, SanofiAventis, Angelini, Recordati, Sunovion, Geodon Richter.

Figures

1
1
Study flow diagram (results of the original search) For the review update in 2018: 3 reports describing the 2 studies originally excluded from quantitative synthesis were moved to excluded studies (no usable data for outcomes of interest); 3 reports on 1 study, originally excluded (short duration of follow‐up), were moved to included studies; one report originally included as independent study was moved as secondary publication of another included study.
2
2
Study flow diagram (results of the 2017/2018/2019 update search and combined results of the original search and the update search)
3
3
Size of trial over time
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
Funnel plot of comparison: 1 Maintenance treatment with antipsychotic drugs versus placebo/no treatment, outcome: Relapse
7
7
Meta‐regression on duration of clinical stability before study start (relapse at 12 months) The size of the bubbles is proportional to the inverse variance of the treatment effect.
8
8
Meta‐regression on duration of taper in the placebo group (relapse at 12 months) The size of the bubbles is proportional to the inverse variance of treatment effect.
9
9
Meta‐regression on mean dose in chlorpromazine equivalents (relapse at 12 months) The size of the bubbles is proportional to the inverse variance of treatment effect.
10
10
Meta‐regression on study duration (relapse, all studies included). The size of the bubbles is proportional to the inverse variance of treatment effect.
1.1
1.1. Analysis
Comparison 1: Maintenance treatment with antipsychotic drugs versus placebo/no treatment, Outcome 1: Relapse: 1. Within pre‐specified time periods
1.2
1.2. Analysis
Comparison 1: Maintenance treatment with antipsychotic drugs versus placebo/no treatment, Outcome 2: Relapse: 2. Independent of duration
1.3
1.3. Analysis
Comparison 1: Maintenance treatment with antipsychotic drugs versus placebo/no treatment, Outcome 3: Leaving the study early: 1. Due to any reason (acceptability of treatment)
1.4
1.4. Analysis
Comparison 1: Maintenance treatment with antipsychotic drugs versus placebo/no treatment, Outcome 4: Leaving the study early: 2. Due to adverse events (overall tolerability)
1.5
1.5. Analysis
Comparison 1: Maintenance treatment with antipsychotic drugs versus placebo/no treatment, Outcome 5: Leaving the study early: 3. Due to inefficacy
1.6
1.6. Analysis
Comparison 1: Maintenance treatment with antipsychotic drugs versus placebo/no treatment, Outcome 6: Global state: number of participants improved (at least minimally)
1.7
1.7. Analysis
Comparison 1: Maintenance treatment with antipsychotic drugs versus placebo/no treatment, Outcome 7: Global state: number of participants in symptomatic remission
1.8
1.8. Analysis
Comparison 1: Maintenance treatment with antipsychotic drugs versus placebo/no treatment, Outcome 8: Global state: number of participants in sustained remission
1.9
1.9. Analysis
Comparison 1: Maintenance treatment with antipsychotic drugs versus placebo/no treatment, Outcome 9: Service use: number of participants hospitalised
1.10
1.10. Analysis
Comparison 1: Maintenance treatment with antipsychotic drugs versus placebo/no treatment, Outcome 10: Service use: number of participants discharged
1.11
1.11. Analysis
Comparison 1: Maintenance treatment with antipsychotic drugs versus placebo/no treatment, Outcome 11: Death: due to any reason
1.12
1.12. Analysis
Comparison 1: Maintenance treatment with antipsychotic drugs versus placebo/no treatment, Outcome 12: Death: due to natural causes
1.13
1.13. Analysis
Comparison 1: Maintenance treatment with antipsychotic drugs versus placebo/no treatment, Outcome 13: Death: due to suicide
1.14
1.14. Analysis
Comparison 1: Maintenance treatment with antipsychotic drugs versus placebo/no treatment, Outcome 14: Number with suicide attempts
1.15
1.15. Analysis
Comparison 1: Maintenance treatment with antipsychotic drugs versus placebo/no treatment, Outcome 15: Number with suicide ideation
1.16
1.16. Analysis
Comparison 1: Maintenance treatment with antipsychotic drugs versus placebo/no treatment, Outcome 16: Violent/aggressive behaviour
1.17
1.17. Analysis
Comparison 1: Maintenance treatment with antipsychotic drugs versus placebo/no treatment, Outcome 17: Adverse effects: at least one adverse event
1.18
1.18. Analysis
Comparison 1: Maintenance treatment with antipsychotic drugs versus placebo/no treatment, Outcome 18: Adverse effects: movement disorders: at least one movement disorder
1.19
1.19. Analysis
Comparison 1: Maintenance treatment with antipsychotic drugs versus placebo/no treatment, Outcome 19: Adverse effects: movement disorders: akathisia
1.20
1.20. Analysis
Comparison 1: Maintenance treatment with antipsychotic drugs versus placebo/no treatment, Outcome 20: Adverse effects: movement disorders: akinesia
1.21
1.21. Analysis
Comparison 1: Maintenance treatment with antipsychotic drugs versus placebo/no treatment, Outcome 21: Adverse effects: movement disorders: dyskinesia
1.22
1.22. Analysis
Comparison 1: Maintenance treatment with antipsychotic drugs versus placebo/no treatment, Outcome 22: Adverse effects: movement disorders: dystonia
1.23
1.23. Analysis
Comparison 1: Maintenance treatment with antipsychotic drugs versus placebo/no treatment, Outcome 23: Adverse effects: movement disorders: rigor
1.24
1.24. Analysis
Comparison 1: Maintenance treatment with antipsychotic drugs versus placebo/no treatment, Outcome 24: Adverse effects: movement disorders: tremor
1.25
1.25. Analysis
Comparison 1: Maintenance treatment with antipsychotic drugs versus placebo/no treatment, Outcome 25: Adverse effects: movement disorders: use of antiparkinson medication
1.26
1.26. Analysis
Comparison 1: Maintenance treatment with antipsychotic drugs versus placebo/no treatment, Outcome 26: Adverse effects: sedation
1.27
1.27. Analysis
Comparison 1: Maintenance treatment with antipsychotic drugs versus placebo/no treatment, Outcome 27: Adverse effects: weight gain
1.28
1.28. Analysis
Comparison 1: Maintenance treatment with antipsychotic drugs versus placebo/no treatment, Outcome 28: Participant´s satisfaction with care
1.29
1.29. Analysis
Comparison 1: Maintenance treatment with antipsychotic drugs versus placebo/no treatment, Outcome 29: Quality of life (various scales, different timepoints)
1.30
1.30. Analysis
Comparison 1: Maintenance treatment with antipsychotic drugs versus placebo/no treatment, Outcome 30: Quality of life (across all scales and timepoints)
1.31
1.31. Analysis
Comparison 1: Maintenance treatment with antipsychotic drugs versus placebo/no treatment, Outcome 31: Number of participants in employment
1.32
1.32. Analysis
Comparison 1: Maintenance treatment with antipsychotic drugs versus placebo/no treatment, Outcome 32: Social Functioning (various scales, different timepoints)
1.33
1.33. Analysis
Comparison 1: Maintenance treatment with antipsychotic drugs versus placebo/no treatment, Outcome 33: Social Functioning (across all scales and timepoints)
2.1
2.1. Analysis
Comparison 2: Subgroup analysis (relapse at 12 months), Outcome 1: Subgroup analysis: participants with a first episode
2.2
2.2. Analysis
Comparison 2: Subgroup analysis (relapse at 12 months), Outcome 2: Subgroup analysis: participants in remission at baseline
2.3
2.3. Analysis
Comparison 2: Subgroup analysis (relapse at 12 months), Outcome 3: Subgroup analysis: various durations of stability before entering the study
2.4
2.4. Analysis
Comparison 2: Subgroup analysis (relapse at 12 months), Outcome 4: Subgroup analysis: abrupt withdrawal versus tapering
2.5
2.5. Analysis
Comparison 2: Subgroup analysis (relapse at 12 months), Outcome 5: Subgroup analysis: single antipsychotic drugs
2.6
2.6. Analysis
Comparison 2: Subgroup analysis (relapse at 12 months), Outcome 6: Subgroup analysis: depot versus oral drugs
2.7
2.7. Analysis
Comparison 2: Subgroup analysis (relapse at 12 months), Outcome 7: Subgroup analysis: first‐ versus second‐generation antipsychotic drugs
2.8
2.8. Analysis
Comparison 2: Subgroup analysis (relapse at 12 months), Outcome 8: Subgroup analysis: appropriate versus unclear allocation concealment
2.9
2.9. Analysis
Comparison 2: Subgroup analysis (relapse at 12 months), Outcome 9: Subgroup analysis: blinded versus open trials
3.1
3.1. Analysis
Comparison 3: Sensitivity analysis (relapse at 12 months), Outcome 1: Exclusion of studies that were not explicitly described as randomised
3.2
3.2. Analysis
Comparison 3: Sensitivity analysis (relapse at 12 months), Outcome 2: Exclusion of non‐double‐blind studies
3.3
3.3. Analysis
Comparison 3: Sensitivity analysis (relapse at 12 months), Outcome 3: Fixed‐effects model
3.4
3.4. Analysis
Comparison 3: Sensitivity analysis (relapse at 12 months), Outcome 4: Original authors' assumptions on dropouts
3.5
3.5. Analysis
Comparison 3: Sensitivity analysis (relapse at 12 months), Outcome 5: Inclusion of only large studies (> 200 participants)
3.6
3.6. Analysis
Comparison 3: Sensitivity analysis (relapse at 12 months), Outcome 6: Exclusion of studies with clinical diagnosis
3.7
3.7. Analysis
Comparison 3: Sensitivity analysis (relapse at 12 months), Outcome 7: Three months stable
3.8
3.8. Analysis
Comparison 3: Sensitivity analysis (relapse at 12 months), Outcome 8: Six months stable
3.9
3.9. Analysis
Comparison 3: Sensitivity analysis (relapse at 12 months), Outcome 9: Nine months stable
3.10
3.10. Analysis
Comparison 3: Sensitivity analysis (relapse at 12 months), Outcome 10: Exclusion of studies with unclear randomisation method
3.11
3.11. Analysis
Comparison 3: Sensitivity analysis (relapse at 12 months), Outcome 11: Exclusion of studies with unclear allocation concealment method
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Fluphenazine 1982 {published data only}1251
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Fluphenazine depot 1968 {published data only}1259
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Fluphenazine depot 1973 {published data only}3723
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Fluphenazine depot 1979a {published data only}1444
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Fluphenazine depot 1979b {published data only}1233
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Fluphenazine depot 1981 {published data only}4324
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Fluphenazine depot 1982 {published data only}2098
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Fluphenazine depot 1992 {published data only}2407
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Haloperidol 1973 {published data only}2232
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Haloperidol 1991 {published data only}2385
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Haloperidol depot 1982 {published data only}3162
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Haloperidol depot 1991 {published data only}9291
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Iloperidone 2016 {published data only}17965
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Olanzapine 1999 {published data only}4622
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Paliperidone 2014 {published data only}22628
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Paliperidone depot1M 2010 {published data only}11886
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Paliperidone depot1M 2015 {published data only}16601
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Paliperidone depot3M 2015 {published data only}18982
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Penfluridol 1974a {published data only}799
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Penfluridol 1974b {published data only}2354
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Penfluridol 1987 {published data only}4221
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Perphenazine 1963 {published data only}
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Pimozide 1971 {published data only}1548
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Pimozide 1973 {published data only}1356
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Quetiapine 2007 {published data only}10847
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Quetiapine 2009a {published and unpublished data}12006
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Quetiapine 2009b {published and unpublished data}12579
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Quetiapine 2010 {published data only}10486
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    1. Leff JP, Wing JK. Trial of maintenance therapy in schizophrenia. British Medical Journal 1971;3:599-604. [CSZG: 3840] - PMC - PubMed
    1. Leff JP. Influence of selection of patients on results of clinical trials. British Medical Journal 1973;4(5885):156-8. [CSZG: 7717] - PMC - PubMed
Various drugs 1974 {published data only}3237
    1. Gross HS. A double-blind comparison of once-a-day pimozide, trifluoperazine, and placebo in the maintenance care of chronic schizophrenic outpatients. Current Therapeutic Research 1974;16:696-705. [CSZG: 3331] - PubMed
Various drugs 1975 {published data only}3868
    1. Clark ML, Huber WK, Hill D, Wood F, Costiloe JP. Pimozide in chronic schizophrenic outpatients. Diseases of the Nervous System 1975;36(3):137-41. [CSZG: 1235] - PubMed
    1. Clark. Pimozide vs thioridazine vs placebo. Bulletin 1973;9:59-63. [CSZG: 4106]
Various drugs 1981a {published data only}6229
    1. Blackburn HL, Allen JL. Behavioral effects of interrupting and resuming tranquilizing medication among schizophrenics. Journal of Nervous and Mental Disease 1981;133:303-8. [CSZG: 8369] - PubMed
Various drugs 1981b {published data only}442
    1. Cheung HK. Schizophrenics fully remitted on neuroleptics for 3-5 years - to stop or continue drugs? British Journal of Psychiatry 1981;138:490-4. [CSZG: 460] - PubMed
Various drugs 1981c {published data only}3827
    1. Wistedt B, Jorgensen A, Wiles D. A depot neuroleptic withdrawal study. Plasma concentration of fluphenazine and flupenthixol and relapse frequency. Psychopharmacology 1982;78:301-4. [CSZG: 27894] - PubMed
    1. Wistedt B, Palmstierna T. Depressive symptoms in chronic schizophrenic patients after withdrawal of long-acting neuroleptics. Journal of Clinical Psychiatry 1983;44:369-71. [CSZG: 3068] - PubMed
    1. Wistedt B, Ranta J. Comparative double-blind study of flupenthixol decanoate and fluphenazine decanoate in the treatment of patients relapsing in a schizophrenic symptomatology. Acta Psychiatrica Scandinavica 1983;67:378-88. [CSZG: 3069] - PubMed
    1. Wistedt B, Wiles D, Jorgensen A. A depot neuroleptic withdrawal study neurological effects. Psychopharmacology 1983;80:101-5. [CSZG: 3070] - PubMed
    1. Wistedt B. A depot neuroleptic withdrawal study. A controlled study of the clinical effects of the withdrawal of depot fluphenazine decanoate and depot flupenthixol decanoate in chronic schizophrenic patients. Acta Psychiatrica Scandinavica 1981;64:65-84. [CSZG: 27892] - PubMed
Various drugs 1982 {published data only}2081
    1. Nishikawa T, Tsuda A, Tanaka M, Koga I, Uchida Y. Prophylactic effect of neuroleptics in symptom-free schizophrenia. Psychopharmacology 1982;77:301-4. [CSZG: 2167] - PubMed
Various drugs 1984a {published data only}
    1. Gardos G, Cole JO, Rapkin RM, LaBrie RA, Baquelod E, Moore P, et al. Anticholinergic challenge and neuroleptic withdrawal. Changes in dyskinesia and symptom measures. Archives of General Psychiatry 1984;41:1030-5. - PubMed
Various drugs 1984b {published data only}2082
    1. Nishikawa T, Tsuda A, Tanaka M, Hoaki Y, Koga I, Uchida Y. Prophylactic effect of neuroleptics in symptom-free schizophrenics: a comparative dose response study of haloperidol and propericiazine. Psychopharmacology 1984;82:153-6. [CSZG: 2168] - PubMed
Various drugs 1986a {published data only}599
    1. Crow TJ, MacMillan JF, Johnson AL, Johnstone EC. A randomised controlled trial of prophylactic neuroleptic treatment. British Journal of Psychiatry 1986;148:120-7. [CSZG: 648] - PubMed
Various drugs 1986b {published data only}2626
    1. Spohn HE, Coyne L, Larson J, Mittleman F, Spray J, Hayes K. Episodic and residual thought pathology in chronic schizophrenics: effect of neuroleptics. Schizophrenia Bulletin 1986;12:394-407. [CSZG: 2712] - PubMed
Various drugs 1989 {published data only}3775
    1. McCreadie RG, Wiles D, Grant S, Crockett GT, Mahmood Z, Livingston MG, et al. The Scottish first episode schizophrenia study. VII two-year follow-up. Acta Psychiatrica Scandinavica 1989;80:597-602. [CSZG: 3968] - PubMed
    1. Scottish Schizophrenia Research Group. The Scottish First Episode Schizophrenia Study II. Treatment. British Journal of Psychiatry 1987;150:334-8. [CSZG: 3969] - PubMed
    1. Scottish Schizophrenia Research Group. The Scottish First Episode Schizophrenia Study V. One-year follow-up. British Journal of Psychiatry 1988;152:470-476. [CSZG: 3970] - PubMed
    1. Scottish Schizophrenia Research Group. The Scottish First Episode Schizophrenia Study. III. Cognitive performance. British Journal of Psychiatry 1987;150:338-340. [CSZG: 16867] - PubMed
    1. Scottish Schizophrenia Research Group. The Scottish first episode schizophrenia study. VIII. Five-year follow-up. British Journal of Psychiatry 1992;161:496-500. [CSZG: 2542] - PubMed
Various drugs 1993 {published data only}2205
    1. Gaebel W, Frick U, Kopcke W, Linden M, Mueller P, Mueller Spahn F, et al. Early neuroleptic intervention in schizophrenia: are prodromal symptoms valid predictors of relapse? British Journal of Psychiatry Supplementum 1993;163:8-12. [CSZG: 831] - PubMed
    1. Gaebel W, Janner M, Frommann N, Pietzcker A, Kopcke W, Linden M, et al. First vs multiple episode schizophrenia: two-year outcome of intermittent and maintenance medication strategies. Schizophrenia Research 2002;53(1-2):145-59. [CSZG: 8197] - PubMed
    1. Gaebel W, Moeller HJ. Treatment strategies in first episode schizophrenia. In: Proceedings of the 12th World Congress of Psychiatry; 2002 Aug 24-29; Yokohama, Japan. 2002. [CSZG: 8597]
    1. Pietzcker A, Gaebel W, Koepcke W, Linden M, Mueller P, Mueller-Spahn F, et al. Intermittent versus maintenance neuroleptic long-term treatment in schizophrenia - 2-year results of a German multicenter study. Journal of Psychiatric Research 1993;27:321-39. [CSZG: 3944]
    1. Pietzcker A, Gaebel W, Kopcke W, Linden M, Muller P, Muller-Spahn, et al. A German multicenter study on the neuroleptic long-term therapy of schizophrenic patients. Preliminary report. Pharmacopsychiatry 1986;19:161-6. [CSZG: 3943]
Various drugs 2011 {published data only}10307
    1. Boonstra G, Burger H, Grobbe DE, Kahn RS. Antipsychotic prophylaxis is needed after remission from a first psychotic episode in schizophrenia patients: results from an aborted randomised trial. International Journal of Psychiatry in Clinical Practice 2011;15(2):128-34. [CSZG: 22940] - PubMed
    1. Boonstra G. Schizophrenia termination of pharmacotherapy-STOP-trial. Current Controlled Trials 2005. [CSZG: 14487] [ISRCTN: 6332944]
Ziprasidone 2002 {published data only}227
    1. Arato M, O'Connor R, Bradbury JE, Meltzer H. Long-term ziprasidone in schizophrenia. In: Proceedings of the 151st Annual Meeting of the American Psychiatric Association; 1998 May 30 - Jun 4; Toronto, Ontario, Canada. 1998. [CSZG: 3189]
    1. Arato M, O'Connor R, Bradbury JE, Meltzer H. The efficacy of ziprasidone in the long-term treatment of negative symptoms and prevention of exacerbation of schizophrenia. In: Proceedings of the 21st Collegium Internationale Neuro-Psychopharmacologicum Congress; 1998 Jul 12-16; Glasgow, UK. Amsterdam, Netherlands: Cambridge University Press, 1998. [CSZG: 3188]
    1. Arato M, O'Connor R, Bradbury JE, Meltzer H. Ziprasidone in the long-term treatment of negative symptoms and prevention of exacerbation of schizophrenia. In: Proceedings of the 9th Congress of the Association of European Psychiatrists; 1998 Sep 20-24; Copenhagen, Denmark. 1998. [CSZG: 3190]
    1. Arato M, O'Connor R, Bradbury JE, Meltzer H. Ziprasidone in the long-term treatment of negative symptoms and prevention of exacerbation of schizophrenia. Schizophrenia Research 1999;36(1-3):270. [CSZG: 5626]
    1. Arato M, O'Connor R, Meltzer H, Bradbury J. Ziprasidone: efficacy in the prevention of relapse and in the long-term treatment of negative symptoms of chronic schizophrenia. In: Proceedings of the 10th European College of Neuropsychopharmacology Congress; 1997 Sep 13-17; Vienna, Austria. 1997. [CSZG: 245]
Zotepine 2000 {published data only}544
    1. Cooper SJ, Butler A, Tweed J, Raniwalla J, Welch C. Zotepine in the prevention of relapse. Biological Psychiatry 1997;42:41s. [CSZG: 17007]
    1. Cooper SJ, Butler A, Tweed J, Raniwalla J, Welch C. Zotepine in the prevention of relapse. In: Proceedings of the 6th World Congress of Biological Psychiatry; 1997 June 22-27; Nice, France. 1997. [CSZG: 569]
    1. Cooper SJ, Butler A, Tweed J, Welch C, Raniwalla J. Zotepine in the prevention of recurrence: a randomised, double-blind, placebo-controlled study for chronic schizophrenia. Psychopharmacology 2000;150:237-43. [CSZG: 5732] - PubMed
    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. In: Proceedings of the 11th European College of Neuropsychopharmacology Congress; 1998 Oct 31 - Nov 4; Paris, France. 1998. [CSZG: 5784]
    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;41:207-8. [CSZG: 4925]

References to studies excluded from this review

Allen 1997 {published data only}
    1. Allen DN, Gilbertson MW, Barry E, Kammen DP, Gurklis JA. Haloperidol improves memory in schizophrenia. In: Proceedings of the 150th Annual Meeting of the American Psychiatric Association; 1997 May 17-22; San Diego, California, USA. 1997.
Bai 2003 {published data only}
    1. Bai YM, Yu SC, Chen JY, Lin CY, Chou P, Lin CC. Risperidone for pre-existing severe tardive dyskinesia: a 48-week prospective follow-up study. International Clinical Psychopharmacology 2005;20:79-85. - PubMed
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Bechdolf 2016 {published data only}
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Bo 2017 {published data only}
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Bourin 2008 {published data only}
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Branchey 1981 {published data only}
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    1. Branchey MH, Branchey LB, Richardson MA. Effects of neuroleptic adjustment on clinical condition and tardive dyskinesia in schizophrenic patients. American Journal of Psychiatry 1981;138:608-12. - PubMed
Breier 1987 {published data only}
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Brown 2018 {published data only}
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Cather 2018 {published data only}
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Cheng 2019 {published data only}
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Chopra 2019 {published data only}
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Chouinard 1980 {published data only}
    1. Chouinard G, Annable L, Jones BD, Collu R. Lack of tolerance to long-term neuroleptic treatment in dopamine tuberoinfundibular system. Acta Psychiatrica Scandinavica 1980;64:353-62. - PubMed
Chouinard 1993 {published data only}
    1. Andris J. Clinical trials van risperidone [Clinical trails van risperidone]. Unknown Source 1997:14.
    1. Chouinard G, Albright PS. Economic and health state utility determinations for schizophrenic patients treated with risperidone or haloperidol. Journal of Clinical Psychopharmacology 1997;17(4):298-307. - PubMed
    1. Chouinard G, Arnott W. The effect of risperidone on extrapyramidal symptoms in chronic schizophrenic patients. Biological Psychiatry 1992;31:158.
    1. Chouinard G, Jones B, Remington G, Bloom D, Addington D, MacEwan GW, et al. A Canadian multicenter placebo-controlled study of fixed doses of risperidone and haloperidol in the treatment of chronic schizophrenic patients. Journal of Clinical Psychopharmacology 1993;13(1):25-40. - PubMed
    1. Chouinard G. Effects of risperidone in tardive dyskinesia: an analysis of the Canadian multicenter risperidone study. Journal of Clinical Psychopharmacology 1995;15(Suppl 1):S36-44. - PubMed
Claghorn 1974 {published data only}
    1. Claghorn JL, Johnstone EE, Cook TH, Itschner L. Group therapy and maintenance treatment of schizophrenics. Archives of General Psychiatry 1974;31:361-5. - PubMed
Clark 1967 {published data only}
    1. Clark ML, Ray TS, Paredes A, Ragland RE, Costiloe JP, Smith CW, et al. Chlorpromazine in women with chronic schizophrenia: the effect on cholesterol levels and cholesterol-behavior relationships. Psychosomatic Medicine 1967;29(6):634-42. - PubMed
Collins 1967 {published data only}
    1. Collins AD, Dundas J. A double-blind trial of amitriptyline-perphenazine, perphenazine and placebo in chronic withdrawn inert schizophrenics. British Journal of Psychiatry 1967;113:1425-9. - PubMed
Condray 1995 {published data only}
    1. Condray R, Van Kammen DP, Steinhauer SR, Kasparek A, Yao JK. Language comprehension in schizophrenia: trait or state indicator? Biological Psychiatry 1995;38:287-96. - PubMed
Curson 1985 {published data only}
    1. Curson DA, Barnes TR, Bamber RW, Platt SD, Hirsch SR, Duffy JC. Long term depot maintenance of chronic schizophrenic out patients: the seven year follow up of the Medical Research Council fluphenazine/placebo trial. II. The incidence of compliance problems, side effects, neurotic symptoms and depression. British Journal of Psychiatry 1985;146:469-74. - PubMed
    1. Curson DA, Barnes TR, Bamber RW, Platt SD, Hirsch SR, Duffy JC. Long-term depot maintenance of chronic schizophrenic out-patients: the seven year follow-up of the Medical Research Council fluphenazine- placebo trial I. Course of illness, stability of diagnosis, and the role of a special maintenance clinic. British Journal of Psychiatry 1985;146:464-9. - PubMed
    1. Curson DA, Barnes TR, Bamber RW, Platt SD, Hirsch SR, Duffy JC. Long-term depot maintenance of chronic schizophrenic out-patients: the seven year follow-up of the Medical Research Council fluphenazine/placebo trial. III. Relapse postponement or relapse prevention? The implications for long-term outcome. British Journal of Psychiatry 1985;146:474-80. - PubMed
Degkwitz 1970 {published data only}
    1. Degkwitz R, Bauer MP, Gruber M, Hampel G, Luxenburger O, Richartz M, et al. Time relationship between the appearance of persisting extrapyramidal hyperkineses and psychotic recurrences following sudden interruption of prolonged neuroleptic therapy of chronic schizophrenic patients. Arzneimittelforschung 1970;20(7):890-3. - PubMed
Diamond 1960 {published data only}
    1. Diamond LS, Marks JB. Discontinuance of tranquilizers among chronic schizophrenic patients receiving maintenance dosage. Journal of Nervous and Mental Disease 1960;131:247-51. - PubMed
Double 1993 {published data only}
    1. Double DB, Warren GC, Evans M, Rowlands RP. Efficacy of maintenance use of anticholinergic agents. Acta Psychiatrica Scandinavica 1993;88:381-4. - PubMed
    1. Elie R, Morin L, Tetreault L. Effects of ethopropazine and trihexyphenidyl on several parameters of the neuroleptic syndrome [Effets de l'ethopropazine et du trihexyphenidyle sur quelques parametres du syndrome neuroleptique]. Encephale 1972;61:32-52. - PubMed
Durgam 2016 {published data only}
    1. Barabassy A, Szatmàri B, Laszlovszky I, Harsanyi J, Acsai K, Sebe B, et al. Efficacy of cariprazine in the treatment of negative symptoms of schizophrenia: post hoc analysis versus aripiprazole. European Neuropsychopharmacology 2019;29(Suppl 1):S417-8.
    1. Cutler AJ, Durgam S, Lu K, Laszlovszky I, Szalai E, Edwards J, Earley W. Efficacy of cariprazine in negative, cognitive, social function symptoms in schizophrenia: post hoc analysis of a randomized controlled trial. European Neuropsychopharmacology 2016;26(2):S551-2.
    1. Durgam S, Earley W, Lu K, Németh G, Laszlovszky I, Szatmari B, Patel M, Nasrallah H. Cariprazine for negative symptoms of schizophrenia: a pooled post-hoc analysis of 2 randomized double-blind placebo and active controlled trials. In: 29th European College of Neuropsychopharmacology Congress. Vienna, Austria, 2016, Sep 17-20.
    1. Marder S, Fleischhacker WW, Earley W, Kaifeng L, Zhong Y, Németh G. Efficacy of cariprazine across symptom domains in patients with acute exacerbation of schizophrenia: pooled analysis from 3 phase II/III studies. European Neuropsychopharmacology 2019;29(1):127-36. - PubMed
Engelhardt 1967 {published data only}
    1. Engelhardt DM, Rosen B, Freedman N, Margolis R. Phenothiazines in prevention of psychiatric hospitalisation. Archives of General Psychiatry 1967;16:98-101. - PubMed
Fleischhacker 2014 {published data only}
    1. Fleischhacker WW, Sanchez R, Perry PP, Jin N, Peters-Strickland T, Johnson BR, et al. Aripiprazole once-monthly for treatment of schizophrenia: double-blind, randomised, non-inferiority study. British Journal of Psychiatriy 2014;205(2):135-44. - PubMed
Francey 2018 {published data only}
    1. Francey S, Nelson B, Jessica G, Lara B, Yuen HP, O'Donoghue B, et al. Antipsychotic medication in first episode psychosis: an RCT to assess the risk benefit ratio. Early Intervention in Psychiatry 2018;12(Suppl 1):70.
    1. Francey S. A randomized placebo-controlled trial of intensive psychosocial treatment plus or minus antipsychotic medication for first episode psychosis with low risk of self harm of aggression. The STAGES study: staged treatment and acceptability guidelines in early psychosis. Early Interventions in Psychiatry 2016;10(Suppl 1):9. - PubMed
    1. O'Donoghue B, Francey SM, Nelson B, Ratheesh A, Allott K, Grahan J, et al. Staged treatment and acceptability guidelines in early psychosis study (STAGES): a randomized placebo-controlled trial of intensive psychosocial treatment plusof minus antipsychotic medication for first episode with low risk of self harm or aggression: study protocol and baseline characteristics of patients. Early Interventions in Psychiatry 2019;13(4):953-60. - PubMed
Freedman 1982 {published data only}
    1. Freedman R, Kirch D, Bell J, Adler LE, Pecevich M, Pachtman E, et al. Clonidine treatment of schizophrenia: double blind comparison to placebo and neuroleptic drugs. Acta Psychiatrica Scandinavica 1982;65:35-45. - PubMed
Gallant 1964 {published data only}
    1. Gallant DM, Edwards CG, Bishop MP, Galbraith GC. Withdrawal symptoms after abrupt cessation of antipsychotic compounds: clinical confirmation in chronic schizophrenics. American Journal of Psychiatry 1964;121:491-3. - PubMed
Gitlin 1988 {published data only}
    1. Gitlin MJ, Midha KK, Fogelson D, Nuechterlein KH. Persistence of fluphenazine in plasma after decanoate withdrawal. Journal of Clinical Psychopharmacology 1988;8:53-6. - PubMed
Gitlin 2001 {published data only}
    1. Gitlin M, Nuechterlein K, Subotnik KL, Ventura J, Mintz J, Fogelson DL, et al. Clinical outcome following neuroleptic discontinuation in patients with remitted recent-onset schizophrenia. American Journal of Psychiatry 2001;158:1835-42. - PubMed
Gleeson 2004 {published data only}
    1. Gleeson J, Wade D, Mcgorry P, Albiston D, Castle D, Gilbert M, et al. Episode ii: prevention of relapse following early psychosis. Schizophrenia Research 2004;70:61-2.
Goldberg 1967 {published data only}
    1. Goldberg SC, Schooler NR, Mattsson N. Paranoid and withdrawal symptoms in schizophrenia: differential symptom reduction over time. Journal of Nervous and Mental Disease 1967;145:158-62. - PubMed
    1. Mefferd RB Jr, Labrosse EH, Gawienowski AM, Williams RJ. Influence of chlorpromazine on certain biochemical variables of chronic male schizophrenics. Journal of Nervous and Mental Disease 1958;127:167-79. - PubMed
Good 1958 {published data only}
    1. Good WW, Sterling M, Holtzman WH. Termination of chlorpromazine with schizophrenic patients. American Journal of Psychiatry 1958;115:443-8. - PubMed
    1. Mefferd RB, Labrosse EH, Gawienowski AM, Williams RJ. Influence of chlorpromazine on certain biochemical variables of chronic male schizophrenics. Journal of Nervous and Mental Disease 1958;127:167-79. - PubMed
Greenberg 1966 {published data only}
    1. Greenberg LM, Roth S. Differential effects of abrupt versus gradual withdrawal of chlorpromazine in hospitalized chronic schizophrenic patients. American Journal of Psychiatry 1966;123:221-6. - PubMed
Hine 1958 {published data only}
    1. Hine FR. Chlorpromazine in schizophrenic withdrawal and in the withdrawn schizophrenic. Journal of Nervous and Mental Disease 1958;127:220-7. - PubMed
Hirsch 1989 {published data only}
    1. Hirsch SR, Jolley AG, Barnes TR, Liddle PF, Curson DA, Patel A, et al. Dysphoric and depressive symptoms in chronic schizophrenia.. Schizophrenia Research 1989;2(3):259-64. - PubMed
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    1. Hirsch SR, Jolley AG. The dysphoric syndrome in schizophrenia and its implications for relapse. British Journal of Psychiatry. Supplements 1989;155(Suppl 5):46-50. - PubMed
Hirsch 1996 {published data only}
    1. Hirsch SR, Bowen JT, Emami J, Cramer P, Jolley A, Haw C, et al. A one year prospective study of the effect of life events and medication in the aetiology of schizophrenic relapse. British Journal of Psychiatry 1996;168:49-56. - PubMed
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Hunt 1967 {published data only}
    1. Hunt PV. A comparison of the effects of oxypertine and trifluoperazine in withdrawn schizophrenics. British Journal of Psychiatry 1967;113:1419-24. - PubMed
Ionescu 1983 {published data only}
    1. Ionescu R, Tiberiu C, Miklos R, Angelescu C, Persiceanu AM. Penfluridol in the maintenance therapy of schizophrenia. Neurologie et Psychiatrie 1983;21:33-41. - PubMed
Janecek 1963 {published data only}
    1. Janecek J, Schiele BC, Bellville T, Anderson R. The effects of withdrawal of trifluoperazine on patients maintained on the combination of tranylcypromine and trifluoperazine: a double-blind study. Current Therapeutic Research, Clinical and Experimental 1963;85:608-15. - PubMed
Johnstone 1988 {published data only}
    1. Johnstone EC, Crow TJ, Frith CD, Owens DG. The Northwick Park "functional" psychosis study: diagnosis and treatment response. Lancet 1988;2:119-25. - PubMed
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Keefe 2018 {published data only}
    1. Keefe RS, Harvey PD, Khan A, Saoud JB, Staner C, Davidson M, et al. Cognitive effects of MIN-101 in patients with schizophrenia and negative symptoms: results from a randomized controlled trial. Journal of Clinical Psychiatry 2018;79(3):17m11753. - PubMed
Kellam 1971 {published data only}
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Lauriello 2005 {published data only}
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Lecrubier 1997 {published data only}
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Liu 2018 {published data only}
    1. Liu CC. A proposed alternative between discontinuation and maintenance of antipsychotics: a guided dose reduction trial for patients with remitted psychosis. Schizophrenia Bulletin 2018;44(Suppl 1):S414.
Loo 1997 {published data only}
    1. Loo H, Poirier-Littre MF, Theron M, Rein W, Fleurot O. Amisulpride versus placebo in the medium-term treatment of the negative symptoms of schizophrenia. British Journal of Psychiatry 1997;170:18-22. - PubMed
Mahal 1975 {published data only}
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Marder 1994 {published data only}
    1. Andris J. Clinical trials van risperidone [Clinical trails van risperidone]. Unknown Source 1997:14.
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References to studies awaiting assessment

Ascher‐Svanum 2011 {published data only}
    1. Ascher-Svanum H, Nyhuis A, Faries D, Novick D, Kinon B. Differences between schizophrenia patients who switch vs discontinue antipsychotic therapy. Schizophrenia Bulletin 2011 March;37(Suppl 1, Abstracts for the 13th International Congress on Schizophrenia Research (ICOSR)):96.
Decot 2011 {published data only}
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Eisenberg 2016 {published data only}
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EUCTR2005‐005499‐34 {published and unpublished data}
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References to ongoing studies

NCT03503318 {published data only}
    1. NCT03503318. A multicenter, randomized, double-blind, placebo-controlled study to evaluate the efficacy, safety, and tolerability of risperidone extended-release injectable suspension (TV-46000) for subcutaneous use as maintenance treatment in adult and adolescent patients with schizophrenia. https://clinicaltrials.gov.
NCT03593213 {published data only}
    1. NCT03593213. Clinical trial evaluating the efficacy, safety and tolerability of cariprazine in a dose-reduction paradigm in the prevention of relapse in patients with schizophrenia. https://clinicaltrials.gov.
NCT03893825 {published data only}
    1. NCT03893825. A study to test if TV-46000 is safe for maintenance treatment of schizophrenia. https://clinicaltrials.gov.

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