Cited by 2,561Schizophrenia research and treatmentMental Health and PsychiatryTreatment of Major Depression

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Comparative efficacy and tolerability of 15 antipsychotic drugs in schizophrenia: a multiple-treatments meta-analysis

Leucht, Stefan, Cipriani, Andrea, Spineli, Loukia, Mavridis, Dimitris, Örey, Deniz, Richter, Franziska, Samara, Myrto, Barbui, Corrado, Engel, Rolf R, Geddes, John R, Kissling, Werner, Stapf, Marko Paul, Lässig, Bettina, Salanti, Georgia, Davis, John M·2013·The Lancet

DOI 10.1016/s0140-6736(13)60733-3

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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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“In light of comparative meta-analyses,(1) cardiometabolic safety has been established as an important consideration when choosing an antipsychotic.(1,3,36) Consistent with previous studies,(17) treatment with lurasidone was associated with minimal changes in prolactin levels, though there was a high degree of variabil…”
BackgroundResult
Variations in Dysbindin-1 are associated with cognitive response to antipsychotic drug treatment
Scheggia, D., Mastrogiacomo, R., Mereu, M., Sannino, S., Straub, R. E., Armando, M., Managò, F., Guadagna, S., Piras, F., Zhang, F., et al. (2018) · Nature Communications · doi:10.1038/s41467-018-04711-w · Cited by 44
A Network Meta-Analysis to Compare the Efficacy of Steroid and Antiviral Medications for Facial Paralysis from Bell´s Palsy
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“Cumulative ranking probability plots have been suggested as a comprehensive and reliable way to present ranking probabilities graphically (8).”
Background
α2-Adrenoceptors are targets for antipsychotic drugs
Brosda, J., Jantschak, F., & Pertz, H. H. (2014) · Psychopharmacology · doi:10.1007/s00213-014-3459-8 · Cited by 45
“However, superiority of second over first-generation APDs is currently under debate (Stargardt et al. 2012; Leucht et al. 2013).”
Background
Managing Negative Symptoms of Schizophrenia: How Far Have We Come?
Kantrowitz, J. T. (2017) · CNS Drugs · doi:10.1007/s40263-017-0428-x · Cited by 46
Antipsychotic drugs for elderly patients with schizophrenia: A systematic review and meta-analysis
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Self-citation
Indicated association between polygenic risk score and treatment-resistance in a naturalistic sample of patients with schizophrenia spectrum disorders
Werner, M. C. F., Wirgenes, K. V., Haram, M., Bettella, F., Lunding, S. H., Rødevand, L. N., Hjell, G., Agartz, I., Djurovic, S., Melle, I. S., et al. (2020) · Schizophrenia Research · doi:10.1016/j.schres.2020.03.006 · Cited by 43
Increased Appetite Plays a Key Role in Olanzapine-Induced Weight Gain in First-Episode Schizophrenia Patients
Huang, J., Hei, G., Yang, Y., Liu, C., Xiao, J., Long, Y., Peng, X., Yang, Y., Zhao, J., & Wu, R. (2020) · Frontiers in Pharmacology · doi:10.3389/fphar.2020.00739 · Cited by 45
“Many randomized clinical trials (RCTs) and meta analyses have suggested that olanzapine is one of the most efficacious antipsychotic drugs in patients with schizophrenia (Leucht et al., 2013; Huhn et al., 2019).”
Background
Mindfulness-based group therapy for in-patients with schizophrenia spectrum disorders - Feasibility, acceptability, and preliminary outcomes of a rater-blinded randomized controlled trial.
Böge, K., Hahne, I., Bergmann, N., Wingenfeld, K., Zierhut, M., Thomas, N., Ta, T. M. T., Bajbouj, M., & Hahn, E. (2021) · Schizophrenia Research · doi:10.1016/j.schres.2020.12.008 · Cited by 44
Systematic review and meta-analysis on predictors of prognosis in patients with schizophrenia spectrum disorders: An overview of current evidence and a call for prospective research and open access to datasets
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“We did not investigate treatment interventions as predictors of outcome because systematic reviews and meta-analysis on these topics are already available (Leucht et al., 2013; Roder et al., 2011).”
Asenapine review, part II: clinical efficacy, safety and tolerability
Citrome, L. (2014) · Expert Opinion on Drug Safety · doi:10.1517/14740338.2014.908183 · Cited by 42
“This ranking differs somewhat from that found by Leucht and colleagues [25], where on the basis of overall change in symptoms asenapine ranked 13 out of 15 (ranked as number 1, demonstrating the most improvement, was clozapine; ranked as number 14 was lurasidone and ranked as number 15, demonstrating the least improve…”
BackgroundResultInfluential
Potential serotonergic agents for the treatment of schizophrenia
Garay, R. P., Bourin, M., de Paillette, E., Samalin, L., Hameg, A., & Llorca, P. (2015) · Expert Opinion on Investigational Drugs · doi:10.1517/13543784.2016.1121995 · Cited by 42
Metabolic Syndrome in South African Patients with Severe Mental Illness: Prevalence and Associated Risk Factors
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“7%) that are associated with the highest risk for MetS [36].”
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Analysis of Catecholamines and Pterins in Inborn Errors of Monoamine Neurotransmitter Metabolism—From Past to Future
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Development and Validation of a Machine Learning Individualized Treatment Rule in First-Episode Schizophrenia
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A phase 3, multicenter study to assess the 1-year safety and tolerability of a combination of olanzapine and samidorphan in patients with schizophrenia: Results from the ENLIGHTEN-2 long-term extension
Kahn, R. S., Silverman, B. L., DiPetrillo, L., Graham, C. E., Jiang, Y., Yin, J. C., Simmons, A., Bhupathi, V., Yu, B., Yagoda, S., et al. (2021) · Schizophrenia Research · doi:10.1016/j.schres.2021.04.009 · Cited by 42
“In schizophrenia, meta-analyses indicate that olanzapine is one of the most effective antipsychotics, both for acute as well as maintenance treatment (Kishimoto et al., 2019; Leucht et al., 2013).”
Background
A systematic review and combined analysis of therapeutic drug monitoring studies for oral paliperidone
Schoretsanitis, G., Spina, E., Hiemke, C., & de León, J. (2018) · Expert Review of Clinical Pharmacology · doi:10.1080/17512433.2018.1478727 · Cited by 42
Maximizing response to first-line antipsychotics in schizophrenia: a review focused on finding from meta-analysis
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Self-citation
A web-based clinical decision tool to support treatment decision-making in psychiatry: a pilot focus group study with clinicians, patients and carers
Henshall, C., Marzano, L., Smith, K., Attenburrow, M.-J., Puntis, S., Zlodre, J., Kelly, K., Broome, M. R., Shaw, S., Barrera, A., et al. (2017) · BMC Psychiatry · doi:10.1186/s12888-017-1406-z · Cited by 41
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Neuromotor Adverse Effects in 342 Youth During 12 Weeks of Naturalistic Treatment With 5 Second-Generation Antipsychotics
Carbon, M., Kapoor, S., Sheridan, E. M., Al‐Jadiri, A., Azzo, S., Sarkaria, T., Kane, J. M., Saito, E., & Correll, C. U. (2015) · Journal of the American Academy of Child & Adolescent Psychiatry · doi:10.1016/j.jaac.2015.06.015 · Cited by 41
New approaches to the management of schizophrenia: focus on aberrant hippocampal drive of dopamine pathways
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“4,35 These studies, and others, 36 have demonstrated that there are no dramatic differences in the efficacies of typical and atypical antipsychotic treatments.”
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Olanzapine promotes the accumulation of lipid droplets and the expression of multiple perilipins in human adipocytes
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Daytime sleepiness associated with lurasidone and quetiapine XR: results from a randomized double-blind, placebo-controlled trial in patients with schizophrenia
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“Lurasidone was ranked as 6 and quetiapine as 11 out of 15 antipsychotic agents (higher number indicates greater sedation).(26) In this 6-week study, both lurasidone 80mg/d and 160mg/d dose groups, as well as quetiapine XR 600mg/d, were associated with comparable and significant reductions in agitation, as assessed usi…”
Method
Hepatic Safety of Atypical Antipsychotics: Current Evidence and Future Directions
Slim, M., Medina‐Cáliz, I., Gonzalez-Jimenez, A., Cabello, M. R., Mayoral, F., Lucena, M. I., & Andrade, R. J. (2016) · Drug Safety · doi:10.1007/s40264-016-0436-7 · Cited by 41
“Despite initial encouraging results for AAPs, systematic reviews [13] and findings from randomized clinical trials and meta-analyses have raised concerns on the reported advantages of AAPs over conventional antipsychotics in terms of long-term efficacy or tolerability at the endocrine, metabolic, and cardiovascular ax…”
Cardiometabolic health, prescribed antipsychotics and health-related quality of life in people with schizophrenia-spectrum disorders: a cross-sectional study
Bressington, D., Mui, J., Tse, M.-L., Gray, R., Cheung, E. F. C., & Chien, W.-T. (2016) · BMC Psychiatry · doi:10.1186/s12888-016-1121-1 · Cited by 40
Long-acting injectable antipsychotics: what, when, and how
Citrome, L. (2021) · CNS Spectrums · doi:10.1017/s1092852921000249 · Cited by 41
Seminars in Clinical Psychopharmacology
King, D. J., & Royal College of Psychiatrists (London) (2020) · Cambridge University Press eBooks · doi:10.1017/9781911623465 · Cited by 41
Olanzapine depot exposure in male rats: Dose-dependent lipogenic effects without concomitant weight gain
Fernø, J., Ersland, K. M., Duus, I. H., González‐García, I., Fossan, K. O., Berge, R. K., Steen, V. M., & Skrede, S. (2015) · European Neuropsychopharmacology · doi:10.1016/j.euroneuro.2015.03.002 · Cited by 43
“weight gain, dyslipidaemia and diabetes (Daumit et al., 2008; Leucht et al., 2013; Newcomer et al., 2008; Rummel-Kluge et al., 2010).”
Sedative Load and Frailty Among Community-Dwelling Population Aged ≥65 Years
Peklar, J., O’Halloran, A. M., Maidment, I., Henman, M. C., Kenny, R. A., & Kos, M. (2014) · Journal of the American Medical Directors Association · doi:10.1016/j.jamda.2014.10.010 · Cited by 41
Hyperprolactinemia and medications for bipolar disorder: Systematic review of a neglected issue in clinical practice
Pacchiarotti, I., Murru, A., Kotzalidis, G. D., Bonnín, C. D. M., Mazzarini, L., Colom, F., & Vieta, E. (2015) · European Neuropsychopharmacology · doi:10.1016/j.euroneuro.2015.04.007 · Cited by 40
“AP effects on sPrl have been widely studied in schizophrenic samples (Gentile, 2013; Leucht et al., 2013; De Hert et al., 2014; Peuskens et al., 2014).”
Background
Metabolic syndrome and aerobic fitness in patients with first-episode schizophrenia, including a 1-year follow-up
Nyboe, L., Vestergaard, C. H., Moeller, M. K., Lund, H., & Videbech, P. (2015) · Schizophrenia Research · doi:10.1016/j.schres.2015.07.053 · Cited by 40
“This could explain a higher baseline prevalence of MetS compared with that found in the EUFEST study as the adverse metabolic effects of antipsychotics are well known and affects patients early in treatment (De Hert et al., 2011; Nielsen et al., 2010; Graham et al., 2008; Tarricone et al., 2010; Leucht et al., 2013).”
Result
Can authorities appreciably enhance the prescribing of oral generic risperidone to conserve resources? Findings from across Europe and their implications
Godman, B., Petzold, M., Bennett, K., Bennie, M., Bucsics, A., Finlayson, A. E. T., Martin, A. A., Persson, M., Piessnegger, J., Raschi, E., et al. (2014) · BMC Medicine · doi:10.1186/1741-7015-12-98 · Cited by 40
“However, this is changing, with post-marketing studies and meta-analyses challenging the definition of typical (first generation) or atypical (second generation) antipsychotic drugs [18,23-27].”
BackgroundSelf-citation
Antipsychotic Treatment in Breast Cancer Patients
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Spanish consensus on the risks and detection of antipsychotic drug-related hyperprolactinaemia
Montejo, A. L., Arango, C., Bernardo, M., Carrasco, J. L., Crespo‐Facorro, B., Cruz, J. J., del Pino, J., Escudero, M. A. G., García‐Rizo, C., González-Pinto, A. M., et al. (2016) · Revista de Psiquiatría y Salud Mental (English Edition) · doi:10.1016/j.rpsmen.2016.06.001 · Cited by 40
An original pharmacoepidemiological–pharmacodynamic method: application to antipsychotic‐induced movement disorders
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Neuroadaptations to antipsychotic drugs: Insights from pre-clinical and human post-mortem studies
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Unraveling the genetic architecture of copy number variants associated with schizophrenia and other neuropsychiatric disorders
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BackgroundInfluential
60 years of placebo-controlled antipsychotic drug trials in acute schizophrenia: Meta-regression of predictors of placebo response
Leucht, S., Chaimani, A., Leucht, C., Huhn, M., Mavridis, D., Helfer, B., Samara, M. T., Cipriani, A., Geddes, J. R., Salanti, G., et al. (2018) · Schizophrenia Research · doi:10.1016/j.schres.2018.05.009 · Cited by 40
Self-citation
Allopregnanolone Treatment Improves Plasma Metabolomic Profile Associated with GABA Metabolism in Fragile X-Associated Tremor/Ataxia Syndrome: a Pilot Study
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Disconnection of drug-response and placebo-response in acute-phase antipsychotic drug trials on schizophrenia? Meta-regression analysis
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Cardiovascular Adverse Reactions During Antipsychotic Treatment: Results of AMSP, A Drug Surveillance Program Between 1993 and 2013
Friedrich, M., Winkler, D., Konstantinidis, A., Huf, W., Engel, R. R., Toto, S., Grohmann, R., & Kasper, S. F. (2019) · The International Journal of Neuropsychopharmacology · doi:10.1093/ijnp/pyz046 · Cited by 40
Self-citation
Extensions of the probabilistic ranking metrics of competing treatments in network meta‐analysis to reflect clinically important relative differences on many outcomes
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“Details about the methodology and results for this systematic review can be found in the relevant publication (Leucht et al., 2013).”
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Polycystic Ovary Syndrome and Psychotic Disorder
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Schizophrenia Research: A Progress Report.
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Topiramate mitigates weight gain in antipsychotic-treated patients with schizophrenia: meta-analysis of randomised controlled trials.
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“Baseline BPRS scores were converted to PANSS scores (Leucht et al., 2013) for subgroup analysis of patient’s baseline psychopathology.”
Method

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: Leucht, Stefan
Cipriani, Andrea
Spineli, Loukia
Mavridis, Dimitris
Samara, Myrto
Barbui, Corrado
Engel, Rolf R
Geddes, John R
Salanti, Georgia
Davis, John M
Venue: The Lancet
Publisher: Elsevier BV
Published: 2013-09
Volume: 382
Issue: 9896
Pages: 951-962
ISSN: 0099-5355 (ISSN-L)
0140-6736
DOI: 10.1016/s0140-6736(13)60733-3
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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Comparative efficacy and tolerability of 15 antipsychotic drugs in schizophrenia: a multiple-treatments meta-analysis

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