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Comparative efficacy and tolerability of 15 antipsychotic drugs in schizophrenia: a multiple-treatments meta-analysis
Abstract
Background The question of which antipsychotic drug should be preferred for the treatment of schizophrenia is controversial, and conventional pairwise meta-analyses cannot provide a hierarchy based on the randomised evidence. We aimed to integrate the available evidence to create hierarchies of the comparative efficacy, risk of all-cause discontinuation, and major side-effects of antipsychotic drugs.Methods We did a Bayesian-framework, multiple-treatments meta-analysis (which uses both direct and indirect comparisons) of randomised controlled trials to compare 15 antipsychotic drugs and placebo in the acute treatment of schizophrenia. We searched the Cochrane Schizophrenia Group's specialised register, Medline, Embase, the Cochrane Central Register of Controlled Trials, and ClinicalTrials.gov for reports published up to Sept 1, 2012. Search results were supplemented by reports from the US Food and Drug Administration website and by data requested from pharmaceutical companies. Blinded, randomised controlled trials of patients with schizophrenia or related disorders were eligible. We excluded trials done in patients with predominant negative symptoms, concomitant medical illness, or treatment resistance, and those done in stable patients. Data for seven outcomes were independently extracted by two reviewers. The primary outcome was efficacy, as measured by mean overall change in symptoms. We also examined all-cause discontinuation, weight gain, extrapyramidal side-effects, prolactin increase, QTc prolongation, and sedation.Findings We identified 212 suitable trials, with data for 43 049 participants. All drugs were significantly more effective than placebo. The standardised mean differences with 95% credible intervals were: clozapine 0·88, 0·73-1·03; amisulpride 0·66, 0·53-0·78; olanzapine 0·59, 0·53-0·65; risperidone 0·56, 0·50-0·63; paliperidone 0·50, 0·39-0·60; zotepine 0·49, 0·31-0·66; haloperidol 0·45, 0·39-0·51; quetiapine 0·44, 0·35-0·52; aripiprazole 0·43, 0·34-0·52; sertindole 0·39, 0·26-0·52; ziprasidone 0·39, 0·30-0·49; chlorpromazine 0·38, 0·23-0·54; asenapine 0·38, 0·25-0·51; lurasidone 0·33, 0·21-0·45; and iloperidone 0·33, 0·22-0·43. Odds ratios compared with placebo for all-cause discontinuation ranged from 0·43 for the best drug (amisulpride) to 0·80 for the worst drug (haloperidol); for extrapyramidal side-effects 0·30 (clozapine) to 4·76 (haloperidol); and for sedation 1·42 (amisulpride) to 8·82 (clozapine). Standardised mean differences compared with placebo for weight gain varied from -0·09 for the best drug (haloperidol) to -0·74 for the worst drug (olanzapine), for prolactin increase 0·22 (aripiprazole) to -1·30 (paliperidone), and for QTc prolongation 0·10 (lurasidone) to -0·90 (sertindole). Efficacy outcomes did not change substantially after removal of placebo or haloperidol groups, or when dose, percentage of withdrawals, extent of blinding, pharmaceutical industry sponsorship, study duration, chronicity, and year of publication were accounted for in meta-regressions and sensitivity analyses.Interpretation Antipsychotics differed substantially in side-effects, and small but robust differences were seen in efficacy. Our findings challenge the straightforward classification of antipsychotics into first-generation and second-generation groupings. Rather, hierarchies in the different domains should help clinicians to adapt the choice of antipsychotic drug to the needs of individual patients. These findings should be considered by mental health policy makers and in the revision of clinical practice guidelines.Funding None.
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“Some antipsychotics are more effective for psychosis than others – clozapine has been recognised as the most effective antipsychotic drug, followed by a mid-efficacy group of amisulpride, olanzapine, risperidone and paliperidone, then the remaining novel and old antipsychotics such as haloperidol and chlorpromazine.1”
From Stopping and switching antipsychotic drugs (2019) · cites this paper as [1]
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“Unlike other antipsychotics, aripiprazole is associated with fewer adverse effects such as sedation, weight gain, cholesterol and prolactin increase [31].”
From Clinical Advances in Treatment Strategies for Obsessive-compulsive Disorder in Adults (2023) · cites this paper as [31]
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“For example, the provision of gym-based resistance exercise may offer a clinical pathway to care for young people with early psychosis, 244 or veterans with posttraumatic stress disorder 245 .”
From The Lancet Psychiatry Commission: a blueprint for protecting physical health in people with mental illness (2019) · cites this paper as [244]
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Mizuno, Y., McCutcheon, R. A., Brugger, S. P., & Howes, O. D. (2019) · Neuropsychopharmacology · doi:10.1038/s41386-019-0577-3 · Cited by 116
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“Exclusion criteria were: (1) meeting DSM-IV criteria for current substance-induced psychotic disorder, psychotic disorder due to a general medical condition, delusional disorder, brief psychotic disorder, shared psychotic disorder, or mood disorder (major depression or bipolar) with psychotic features; (2) serious neu…”
BackgroundQuintana, D. S., Guastella, A. J., Westlye, L. T., & Andreassen, O. A. (2016) · Molecular Psychiatry · doi:10.1038/mp.2015.166 · Cited by 107
Schoretsanitis, G., Kane, J. M., Ruan, C., Spina, E., Hiemke, C., & de León, J. (2019) · Expert Review of Clinical Pharmacology · doi:10.1080/17512433.2019.1617695 · Cited by 113
“This is the narrowest of therapeutic indexes among secondgeneration antipsychotics, which indicates that it may be the most prone to cause dose-dependent ADRs [72].”
BackgroundInfluentialAntidepressants plus benzodiazepines for adults with major depression
Ogawa, Y., Takeshima, N., Hayasaka, Y., Tajika, A., Watanabe, N., Streiner, D. L., & Furukawa, T. A. (2019) · Cochrane Database of Systematic Reviews · doi:10.1002/14651858.cd001026.pub2 · Cited by 117
Ennis, Z. N., & Damkier, P. (2014) · Basic & Clinical Pharmacology & Toxicology · doi:10.1111/bcpt.12372 · Cited by 110
Pharmacotherapy of treatment-resistant schizophrenia: a clinical perspective
Dold, M., & Leucht, S. (2014) · Evidence-Based Mental Health · doi:10.1136/eb-2014-101813 · Cited by 114
Self-citationWang, G., Zheng, W., Li, X.-B., Wang, S.-B., Cai, D.-B., Yang, X.-H., Ungvari, G. S., Xiang, Y., & Correll, C. U. (2018) · Journal of Psychiatric Research · doi:10.1016/j.jpsychires.2018.08.002 · Cited by 108
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“19 20 In this study, we did not set out to compare movement side effects between first and second-generation agents but we observed that the prescription of second-generation agents was associated with a slightly lower incidence of recorded movement side effects in people with and without ID;…”
BackgroundNikolakopoulou, A., Mavridis, D., Furukawa, T. A., Cipriani, A., Tricco, A. C., Straus, S. E., Siontis, G. C. M., Egger, M., & Salanti, G. (2018) · BMJ · doi:10.1136/bmj.k585 · Cited by 109
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Classics in Chemical Neuroscience: Risperidone
Chopko, T. C., & Lindsley, C. W. (2018) · ACS Chemical Neuroscience · doi:10.1021/acschemneuro.8b00159 · Cited by 105
Antipsychotic Drugs and Cognitive Function
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“15 Surprisingly, the only specific antipsychotic adverse side-effect mentioned in CG178 is photo-sensitivity with chlorpromazine.”
Understanding Psychosis and Schizophrenia
Cooke, A. (2014) · Cited by 163
Treatment Recommendations for Tardive Dyskinesia
Ricciardi, L., Pringsheim, T. M., Barnes, T. R. E., Martino, D., Gardner, D. M., Remington, G. J., Addington, D. E., Morgante, F., Poole, N. A., Carson, A. J., et al. (2019) · The Canadian Journal of Psychiatry · doi:10.1177/0706743719828968 · Cited by 104
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“Controversies regarding potentially fewer side effects, generally safer profi le and better tolerability of atypicals versus typicals are still not clarifi ed in psychiatric literature (Leucht et al., 2003, 2009, 2013).”
BackgroundHasan, A., Falkai, P., Wobrock, T., Lieberman, J. A., Glenthoj, B. Y., Gattaz, W. F., Thibaut, F., Möller, H., & WFSBP Task Force on Treatment Guidelines for Schizophrenia (2017) · International Journal of Psychiatry in Clinical Practice · doi:10.1080/13651501.2017.1291839 · Cited by 102
“Current discussions prefer a risk–benefit orientated classification of antipsychotics rather than a straightforward classification into only two subgroups (Leucht et al. 2013).”
BackgroundMurphy, R., & Hutton, P. (2017) · Journal of Child Psychology and Psychiatry · doi:10.1111/jcpp.12767 · Cited by 102
“Hierarchical approaches to outcome selection have been used in several recent meta-analyses of psychiatric treatments and are preferable to computing an aggregate effect size for each study, that is, an average of all reported outcomes (e.g. Hutton & Taylor, 2014; Leucht et al., 2013; Stovell, Morrison, Panayiotou, &…”
MethodCicala, G., Barbieri, M. A., Spina, E., & de León, J. (2019) · Expert Review of Clinical Pharmacology · doi:10.1080/17512433.2019.1577134 · Cited by 105
“Despite that, the randomized clinical trials (RCTs) for indications of schizophrenia and bipolar disorder of the more recently marketed SGAPs do not provide information on the prevalence of these ADRs, since the individuals who are included in RCTs are relatively healthy.”
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Multi-Target Approach for Drug Discovery against Schizophrenia
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“F rthermo e, aripiprazole is cha acterized by better t rability compared to other antipsychotics [113].”
BackgroundAntipsychotic treatment of schizophrenia: An update
Bruijnzeel, D. M., Suryadevara, U., & Tandon, R. (2014) · Asian Journal of Psychiatry · doi:10.1016/j.ajp.2014.08.002 · Cited by 105
“, 2006; Tandon and Nasrallah, 2006), the modest differential efficacy cannot be dismissed as a mere methodological artifact (Leucht et al., 2013).”
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“when pharmaceutical industry sponsorship was accounted for in meta-regressions and sensitivity analyses [299].”
BackgroundInfluentialGuide to the Management of Clozapine-Related Tolerability and Safety Concerns
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Molecular Mechanisms of Antipsychotic Drug-Induced Diabetes
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“Antipsychotic drugs (APDs) are widely prescribed to control schizophrenia and bipolar disorders, as well as other mental disorders including dementia, major depression, and even drug addiction (Fraguas et al., 2011; Leucht et al., 2013; Zhang J.-P. et al., 2013; Samara et al., 2016).”
BackgroundMedications that cause weight gain and alternatives in Canada: a narrative review
Wharton, S., Raiber, L., Serodio, K., Lee, J., & Christensen, R. A. (2018) · Diabetes, Metabolic Syndrome and Obesity: Targets and Therapy · doi:10.2147/dmso.s171365 · Cited by 100
The Role of Clozapine in Treatment-Resistant Schizophrenia
Kane, J. M., & Correll, C. U. (2016) · JAMA Psychiatry · doi:10.1001/jamapsychiatry.2015.2966 · Cited by 98
Language disturbances in schizophrenia: the relation with antipsychotic medication
de Boer, J. N., Voppel, A., Brederoo, S., Wijnen, F. N. K., & Sommer, I. E. (2020) · Schizophrenia · doi:10.1038/s41537-020-00114-3 · Cited by 97
Fernández-Abascal, B., Suárez‐Pinilla, P., Cobo-Corrales, C., Crespo‐Facorro, B., & Suárez‐Pinilla, M. (2021) · Neuroscience & Biobehavioral Reviews · doi:10.1016/j.neubiorev.2021.01.005 · Cited by 93
“and metabolic impairments (Cooper et al., 2016; Leucht et al., 2013), moreover, for some drugs, higher doses might not provide more efficacy but increase secondary effects (Leucht et al.”
Background
Metadata
- Authors
- Leucht, S., Cipriani, A., Spineli, L., Mavridis, D., Örey, D., Richter, F., Samara, M., Barbui, C., Engel, R. R., Geddes, J. R., Kissling, W., Stapf, M. P., Lässig, B., Salanti, G., & Davis, J. M.
- Affiliations
- TUM Klinikum (DE)
- University of Verona (IT)
- University of Ioannina (GR)
- Ludwig-Maximilians-Universität München (DE)
- Warneford Hospital (GB)
- University of Illinois Chicago (US)
- Corresponding author
- Leucht, Stefan
- ORCID
- Venue
- The Lancet
- Publisher
- Elsevier BV
- Published
- 2013-09
- Volume
- 382
- Issue
- 9896
- Pages
- 951-962
- ISSN
- 0099-5355 (ISSN-L)
- 0140-6736
- OpenAlex
- W2009832071
- Cited by
- 2,561
- References
- 61
- Citations by year
- 2026: 134 · 2025: 135 · 2024: 161 · 2023: 146 · 2022: 182 · 2021: 215 · 2020: 223 · 2019: 221 · 2018: 217 · 2017: 228 · 2016: 255 · 2015: 243 · 2014: 160 · 2013: 36
- FWCI
- 164.63
- Type
- journal article
- Language
- en
- Open access
- closed
- Locations
- The Lancet (publishedVersion)
- PubMed (publishedVersion)
- mediaTUM – the media and publications repository of the Technical University Munich (Technical University Munich) (submittedVersion)
- Funders
- National Institute for Health and Care Research (NF-SI-0611-10150)
- H. Lundbeck A/S
- Medical Research Council
- Topics
- Health Sciences › Medicine › Psychiatry and Mental health › Schizophrenia research and treatment
- Social Sciences › Arts and Humanities › Philosophy › Mental Health and Psychiatry
- Health Sciences › Medicine › Pharmacology (medical) › Treatment of Major Depression
- Keywords
- schizophrenia, antipsychotic drugs, drug efficacy comparison, tolerability, Bayesian framework, weight gain, extrapyramidal symptoms, QTc prolongation, sedation, clozapine, amisulpride, olanzapine, risperidone, paliperidone, zotepine
- MeSH terms
- Adult, Humans, Schizophrenia, Antipsychotic Agents, Randomized Controlled Trials as Topic, Treatment Outcome
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