Representation and Outcomes of Individuals With Schizophrenia Seen in Everyday Practice Who Are Ineligible for Randomized Clinical Trials

Taipale, Heidi; Schneider-Thoma, Johannes; Pinzón-Espinosa, Justo; Radua, Joaquim; Efthimiou, Orestis; Vinkers, Christiaan H.; Mittendorfer-Rutz, Ellenor; Cardoner, Narcís; Pintor, Luis; Tanskanen, Antti; Tomlinson, Anneka; Fusar-Poli, Paolo; Cipriani, Andrea; Vieta, Eduard; Leucht, Stefan; Tiihonen, Jari; Luykx, Jurjen J.

doi:10.1001/jamapsychiatry.2021.3990

Cited by 129Schizophrenia research and treatmentMental Health Treatment and AccessPsychiatric care and mental health services

Representation and Outcomes of Individuals With Schizophrenia Seen in Everyday Practice Who Are Ineligible for Randomized Clinical Trials

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Taipale, Heidi, Schneider-Thoma, Johannes, Pinzón-Espinosa, Justo, Radua, Joaquim, Efthimiou, Orestis, Vinkers, Christiaan H., Mittendorfer-Rutz, Ellenor, Cardoner, Narcís +9 more·2022·JAMA Psychiatry

DOI 10.1001/jamapsychiatry.2021.3990PMC PMC8792792

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Abstract

IMPORTANCE: Most evidence about efficacy and safety of antipsychotics in schizophrenia spectrum disorders relies on randomized clinical trials (RCTs). However, owing to their strict eligibility criteria, RCTs represent only a part of the real-world population (ie, unselected patients seen in everyday clinical practice), which may result in an efficacy-effectiveness gap. OBJECTIVE: To quantify the proportion of real-world individuals with schizophrenia spectrum disorders who would be ineligible for participation in RCTs, and to explore whether clinical outcomes differ between eligible and ineligible individuals. DESIGN, SETTING, AND PARTICIPANTS: This study applied eligibility criteria typically used in RCTs for relapse prevention in schizophrenia spectrum disorders to real-world populations. Individuals with diagnoses of schizophrenia spectrum disorders recorded in national patient registries in Finland and Sweden were identified. Individuals who had used antipsychotics continuously for 12 weeks in outpatient care were selected. Individuals were followed up for up to 1 year while they were receiving maintenance treatment with any second-generation antipsychotic (excluding clozapine). Follow-up was censored at treatment discontinuation, initiation of add-on antipsychotics, death, and end of database linkage. MAIN OUTCOMES AND MEASURES: Proportions of RCT-ineligible individuals with schizophrenia spectrum disorders owing to any and specific RCT exclusion criteria. The risk of hospitalization due to psychosis within 1-year follow-up in ineligible vs eligible persons were compared using hazard ratios (HR) and corresponding 95% CIs. RESULTS: The mean (SD) age in the Finnish cohort (n = 17 801) was 47.5 (13.8) years and 8972 (50.4%) were women; the mean (SD) age in the Swedish cohort (n = 7458) was 44.8 (12.5) years and 3344 (44.8%) were women. A total of 20 060 individuals (79%) with schizophrenia spectrum disorders would be ineligible for RCTs (Finnish cohort: 14 221 of 17 801 [79.9%]; Swedish cohort: 5839 of 7458 [78.3%]). Most frequent reasons for ineligibility were serious somatic comorbidities and concomitant antidepressant/mood stabilizer use. Risks of hospitalization due to psychosis was higher among ineligible than eligible individuals (Finnish cohort: 18.4% vs 17.2%; HR, 1.14 [95% CI, 1.04-1.24]; Swedish cohort: 20.1% vs 14.8%; HR, 1.47 [95% CI, 1.28-1.92]). The largest risks of hospitalization due to psychosis were observed in individuals ineligible owing to treatment resistance, tardive dyskinesia, and history of suicide attempts. Finally, with more ineligibility criteria met, larger risks of hospitalization due to psychosis were observed in both countries. CONCLUSIONS AND RELEVANCE: RCTs may represent only about a fifth of real-world individuals with schizophrenia spectrum disorders. Underrepresented (ineligible) patients with schizophrenia spectrum disorders have moderately higher risks of admission due to psychosis while receiving maintenance treatment than RCT-eligible patients. These findings set the stage for future studies targeting real-world populations currently not represented by RCTs.

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In RCTs of medications for schizophrenia, 79% of individuals with schizophrenia spectrum disorders would be deemed ineligible, primarily due to exclusion criteria that eliminate many individuals with comorbid conditions and more severe manifestations.
“Research of RCTs on medications for schizophrenia highlights the significant disparity between the broader patient population and those who qualify for trials, primarily due to exclusion criteria that eliminate many individuals with comorbid conditions and more severe manifestations of the disorder: 79% of individuals with schizophrenia spectrum disorders would be deemed ineligible for RCTs.15”
From Evaluating ADHD medication trial representativeness: a Swedish population-based study comparing hypothetically trial-eligible and trial-ineligible individuals (2025) · cites this paper as [15]
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About 20% of people with schizophrenia spectrum disorders would be eligible for inclusion in a typical randomised clinical trial.
“a study found only about 20% of people who have schizophrenia spectrum disorders would be eligible for inclusion in a typical randomised clinical trial.”
From Developing clinical prediction models: a step-by-step guide (2024) · cites this paper as [46]
Patients with schizophrenia spectrum disorders who are ineligible for a typical randomised clinical trial had a higher risk of hospital admission with psychosis than those who are eligible.
“Patients who are ineligible had a higher risk of hospital admission with psychosis than those who are eligible.46”
From Developing clinical prediction models: a step-by-step guide (2024) · cites this paper as [46]

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[8]Luykx JJ, Pinzón-Espinosa J, Schneider-Thoma J, What is the Impact of Randomized Controlled Trials Inclusion and Exclusion Criteria on Outcomes in People using Antipsychotics in the Real World? A Systematic Analysis in National Registries. OSF Regist; 2020. doi: 10.17605/OSF.IO/ZRBW7 · DOI

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Real-World Effectiveness of Menopausal Hormone Therapy in Preventing Relapse in Women With Schizophrenia or Schizoaffective Disorder
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Paliperidone palmitate vs. paliperidone extended-release for the acute treatment of adults with schizophrenia: a systematic review and pairwise and network meta-analysis
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Racial Disparities Among Clinical High-Risk and First-Episode Psychosis Multisite Research Participants: A Systematic Review
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A real-world study of the association between cardiovascular risk factors and depression symptom trajectory in individuals with mental illness
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Evidence-based clinical care and policy making for schizophrenia
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Prevalence and Temporal Trends of Mental Disorders in Persons with Opioid Use Disorder and Concurrent Mental Disorders in British Columbia, Canada, Using Population-Level Administrative Data, 2013 to 2021: Prévalence et tendances temporelles des troubles mentaux chez les personnes souffrant d’un trouble lié à la consommation d’opioïdes et de troubles mentaux concomitants en Colombie-Britannique, au Canada, à partir de données administratives au niveau de la population, entre 2013 et 2021
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Long term safety of ADHD medication in patients with schizophrenia spectrum disorders
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Risperidone-ISM ® effectiveness and tolerability in acute schizophrenia patients hospitalised due to a relapse: results from an international, prospective, non-interventional evaluation (RESHAPE study)
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Cardiovascular Disease Burden in Persons with Mental Illness: Comparison between a U.S. Psychiatry Outpatient Sample and a U.S. General Population Sample
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Expanded access to investigational drugs in psychiatry: A systematic review
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Obstacles, Opportunities, and Ethical Considerations for Genomic Investigations of Individuals Continuously Hospitalized with Treatment-resistant Schizophrenia
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Effectiveness of Long-Acting Injectable Antipsychotics Versus Oral Antipsychotics in People With Bipolar Disorder: A Systematic Review and Meta-Analysis of Observational Studies: Efficacité des antipsychotiques injectables à action prolongée par rapport aux antipsychotiques oraux chez les personnes atteintes de troubles bipolaires : revue systématique et méta-analyse d'études observationnelles
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First generation antipsychotic-associated serious adverse events in women: a retrospective analysis of a pharmacovigilance database
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Frequency, correlates and outcomes of Benzodiazepine use during Cariprazine treatment: A pooled post-hoc analysis from four 6-week, placebo-controlled trials in patients with an acute exacerbation of schizophrenia
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Are antipsychotic drugs effective against acute psychosis?
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Aktuelle Aspekte zur antipsychotischen Behandlung älterer Menschen mit Erkrankungen des schizophrenen Spektrums
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Sex differences in clinical trial enrollment in the United States across psychiatric disorders
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Association Between Current Suicidal Ideation and Personality Traits: Analysis of the Personality Inventory for DSM-5 in a Community Mental Health Sample
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Quantitative semiology: harnessing AI-generated teaching signals in psychiatry
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Evaluation of preclinical antipsychotic models used to support first‐in‐human clinical trials
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Second-Generation Antipsychotics and Real-World Outcomes in Youth With On- and Off-Label Indications
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Stimulant‐induced psychosis requires the same clinical priority as other psychotic disorders
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Safety profile and potential clinical risks of xanomeline and trospium chloride: A real-world pharmacovigilance study using FAERS
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Predicting functional remission after antipsychotic discontinuation: a real-world study in schizophrenia
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Long-term antipsychotic use and cardiometabolic adverse effects in adults with non-psychotic disorders: A systematic review
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Clinical and Neurobiological Characterization of Akathisia in Schizophrenia Spectrum Disorders and Mood Disorders
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Kaleidoscope
Tracy, D. K., Joyce, D. W., Albertson, D. N., & Shergill, S. S. (2022) · The British Journal of Psychiatry · doi:10.1192/bjp.2022.45 · Cited by 1 · see citing works
Regarding “Risk of Cancers Proximal to the Colon in Fecal Immunochemical Test Positive Screenees in a Colorectal Cancer Screening Program”
Wu, J., Zhang, Z., & Zhang, L. (2024) · Gastroenterology · doi:10.1053/j.gastro.2024.09.046 · Cited by 1 · see citing works

Mind the gap: representation and outcomes of individuals with schizophrenia or major depressive disorder not eligible for randomized controlled trials
Taipale, H. T., & working group of Aleksi Hamina, J. P.-E. (2026) · European Psychiatry · doi:10.1192/j.eurpsy.2026.10318
Self-citation
Trial‐ineligible patients with schizophrenia have higher risk of adverse outcomes
(2022) · The Brown University Psychopharmacology Update · doi:10.1002/pu.30866
Eligibility of schizophrenia inpatients to participate in clinical trials
Iniesta, E., Lucas, M., Ruiz, J., PORTELA, M. C. M., Romero-Rodenas, P., Tolosa, M., Díaz, M. C., Martín, M. Á., Nieto, K., Martínez, M. D., et al. (2012) · Revista de Psiquiatría y Salud Mental (English Edition) · doi:10.1016/j.rpsmen.2011.10.001
REPRESENTATIVENESS OF CLINICAL ANTIPSYCHOTIC TRIAL SAMPLES WHEN COMPARED WITH A GENERAL POPULATION-BASED SAMPLE
Rahkonen, H., Alakokkare, A.-E., Haapea, M., Isohanni, M. K., Jääskeläinen, E., & Miettunen, J. (2023) · DOAJ (DOAJ: Directory of Open Access Journals)
Antipsychotic effects in randomized trials may not reflect real‐world outcomes
(2024) · The Brown University Psychopharmacology Update · doi:10.1002/pu.31173

Authors: Taipale, H., Schneider-Thoma, J., Pinzón-Espinosa, J., Radua, J., Efthimiou, O., Vinkers, C. H., Mittendorfer-Rutz, E., Cardoner, N., Pintor, L., Tanskanen, A., Tomlinson, A., Fusar-Poli, P., Cipriani, A., Vieta, E., Leucht, S., Tiihonen, J., & Luykx, J. J.
Affiliations: University of Eastern Finland (FI)
Department of Psychiatry and Psychotherapy, School of Medicine, Technical University of Munich, Munich, Germany
Universidad de Panamá (PA)
Divisions of Insurance Medicine, Department of Clinical Neuroscience, Karolinska Institutet, Stockholm, Sweden
University of Bern (CH)
Amsterdam Neuroscience (NL)
Department of Mental Health, Parc Tauli University Hospital, Sabadell, Barcelona, Spain
Institut d’Investigacions Biomèdiques August Pi i Sunyer (IDIBAPS), CIBERSAM, Barcelona, Spain
Oxford Health NHS Foundation Trust (GB)
Early Psychosis: Interventions and Clinical-detection (EPIC) Lab, Department of Psychosis Studies, Institute of Psychiatry, Psychology, and Neuroscience, King’s College London, London, United Kingdom
Hospital Clínic de Barcelona (ES)
Technical University of Munich (DE)
Utrecht University (NL)
Corresponding author: Luykx, Jurjen J.
ORCID: Taipale, Heidi
Pinzón-Espinosa, Justo
Efthimiou, Orestis
Vinkers, Christiaan H.
Tanskanen, Antti
Tomlinson, Anneka
Cipriani, Andrea
Vieta, Eduard
Leucht, Stefan
Tiihonen, Jari
Luykx, Jurjen J.
Venue: JAMA Psychiatry
Publisher: American Medical Association (AMA)
Published: 2022-03-01
Volume: 79
Issue: 3
Pages: 210
ISSN: 2168-622X (ISSN-L)
DOI: 10.1001/jamapsychiatry.2021.3990
PMC: PMC8792792
OpenAlex: W4210419267
Cited by: 129
References: 36
Citations by year: 2026: 30 · 2025: 28 · 2024: 33 · 2023: 26 · 2022: 12
FWCI: 16.14
Type: journal article
Language: en
Open access: hybrid
doi.org
Licence: cc-by
Locations: JAMA Psychiatry (publishedVersion, cc-by)
PubMed Central (publishedVersion, cc-by)
PubMed (publishedVersion)
Research Portal (King's College London) (publishedVersion, other-oa)
Pure Amsterdam UMC (publishedVersion, cc-by)
Bern Open Repository and Information System (University of Bern) (submittedVersion)
Research Publications (Maastricht University) (submittedVersion, cc-by)
Dipòsit Digital de Documents de la UAB (Universitat Autònoma de Barcelona) (submittedVersion, cc-by)
Utrecht University Repository (Utrecht University) (submittedVersion, other-oa)
mediaTUM – the media and publications repository of the Technical University Munich (Technical University Munich) (submittedVersion)
mediaTUM – the media and publications repository of the Technical University Munich (Technical University Munich) (submittedVersion, other-oa)
Amsterdam UMC (VU Amsterdam) - Institutional Repository (submittedVersion, other-oa)
Research Publications (Maastricht University) (submittedVersion, other-oa)
Data Archiving and Networked Services (DANS) (submittedVersion, other-oa)
Data Archiving and Networked Services (DANS) (submittedVersion)
Greater South Information System
Funders: National Science Foundation
Eli Lilly and Company
Pfizer
GlaxoSmithKline
Sanofi
Ministerio de Ciencia, Innovación y Universidades
National Institute for Health and Care Research (AI_AWARD02183, RP-2017-08-ST2-006, BRC‐1215‐20005, NIHR Research Professorship (grant RP-2017-08-ST2-)
European Commission (CPII19/00009)
Schweizerischer Nationalfonds zur Förderung der Wissenschaftlichen Forschung (20005, 180083)
Academy of Finland (320107, 315969)
Fondazione Cariplo
Sigrid Juséliuksen Säätiö
Angelini Pharma
Otsuka Pharmaceutical
Casen Recordati
H. Lundbeck A/S
Neuraxpharm
Instituto de Salud Carlos III ((CPII19/00009), PI19/00394)
European Regional Development Fund (CPII19/00009)
Janssen Pharmaceuticals
Cilag
Topics: Health Sciences › Medicine › Psychiatry and Mental health › Schizophrenia research and treatment
Social Sciences › Psychology › Social Psychology › Mental Health Treatment and Access
Social Sciences › Psychology › Clinical Psychology › Psychiatric care and mental health services
Keywords: schizophrenia spectrum disorders, antipsychotic drugs, relapse prevention, long-term antipsychotic treatment, atypical antipsychotics, efficacy-effectiveness gap, somatic comorbidity, real-world outcomes, patient registry, Finland, Sweden
MeSH terms: Adult, Clozapine, Female, Humans, Male, Middle Aged, Psychotic Disorders, Schizophrenia, Antipsychotic Agents, Randomized Controlled Trials as Topic

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Representation and Outcomes of Individuals With Schizophrenia Seen in Everyday Practice Who Are Ineligible for Randomized Clinical Trials

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