Study protocol for Controversies in psychiatry – antipsychotics: Long term outcomes and causal modelling of antipsychotic treatment using Norwegian Registry data

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However, their use remains controversial due to significant side effects and limited efficacy in some patients. This controversy is further compounded by some patients’ preferences to avoid or discontinue use, and the practice of involuntary admissions and antipsychotic medication treatment. Evaluating long-term outcomes, optimal discontinuation strategies, and the risks associated with managing first-episode psychosis without antipsychotics is challenging in randomized controlled trials (RCTs) due to ethical and safety concerns, participant attrition, and feasibility constraints. Real-world clinical practices vary widely in the duration, type, and non-use of antipsychotics due to provider variation. Methods We present a study that will utilize and link multiple longitudinal Norwegian national registry datasets, encompassing mental health care use, prescriptions, hospital emergency care contacts, injury presentations, educational outcomes, employment, criminal justice system contacts, and mortality. These data will enable descriptive analyses of outcomes for patients receiving different types, dosages, durations, and total exposures to antipsychotics, as well as for patients managed without antipsychotics. We also plan to estimate variations in public spending and societal costs. Variation in prescriber preferences will serve as quasi-randomization, allowing for causal inference after testing assumptions. Conclusions This study will provide empirical evidence to inform patients, carers, service providers, and policymakers in making complex decisions about antipsychotic maintenance treatment. Ethics and dissemination Ethic approval was granted by the Regional Ethical Committee for Medical and Health Services Research, Norway (REC South East, Committee D, REK 10895). Data will be pseudonymized for the project. The project group is committed to publishing all relevant findings in peer-reviewed journals, including null findings. " } { "@context": "http://schema.org", "@type": "BreadcrumbList", "itemListElement": [ { "@type": "ListItem", "position": "1", "item": { "@id": "https://f1000research.com/", "name": "Home" } }, { "@type": "ListItem", "position": "2", "item": { "@id": "https://f1000research.com/browse/articles", "name": "Browse" } }, { "@type": "ListItem", "position": "3", "item": { "@id": "https://f1000research.com/articles/14-672/v1", "name": "Study protocol for Controversies in psychiatry – antipsychotics: Long..." } } ] } Home Browse Study protocol for Controversies in psychiatry – antipsychotics: Long... ALL Metrics - Views Downloads Get PDF Get XML Cite How to cite this article Nyttingnes O, Hofstad T, Johnsen E et al. Study protocol for Controversies in psychiatry – antipsychotics: Long term outcomes and causal modelling of antipsychotic treatment using Norwegian Registry data [version 1; peer review: awaiting peer review] . F1000Research 2025, 14 :672 ( https://doi.org/10.12688/f1000research.166156.1 ) NOTE: If applicable, it is important to ensure the information in square brackets after the title is included in all citations of this article. Close Copy Citation Details Export Export Citation Sciwheel EndNote Ref. Manager Bibtex ProCite Sente EXPORT Select a format first Track Share ▬ ✚ Study Protocol Study protocol for Controversies in psychiatry – antipsychotics: Long term outcomes and causal modelling of antipsychotic treatment using Norwegian Registry data [version 1; peer review: awaiting peer review] Olav Nyttingnes https://orcid.org/0000-0003-0991-7176 1,2 , Tore Hofstad 1,3 , Erik Johnsen 4-6 , [...] Maria Fagerbakke Strømme 4 , Simen Markussen 7 , Eóin Killackey 8,9 , Miles Rinaldi 10-12 , Anne Alnes Blindheim 4 , David McDaid 13 , Beate Brinchmann 11 , Ingvar Bjelland 4,5 , Jorun Rugkåsa 2,14,15 , Trond Fjetland Aarre 16 , Knut Rypdal 10 , Arnstein Mykletun 1,11,17,18 Olav Nyttingnes https://orcid.org/0000-0003-0991-7176 1,2 , Tore Hofstad 1,3 , [...] Erik Johnsen 4-6 , Maria Fagerbakke Strømme 4 , Simen Markussen 7 , Eóin Killackey 8,9 , Miles Rinaldi 10-12 , Anne Alnes Blindheim 4 , David McDaid 13 , Beate Brinchmann 11 , Ingvar Bjelland 4,5 , Jorun Rugkåsa 2,14,15 , Trond Fjetland Aarre 16 , Knut Rypdal 10 , Arnstein Mykletun 1,11,17,18 PUBLISHED 07 Jul 2025 Author details Author details 1 Centre for Population Health, Haukeland University Hospital, Bergen, Hordaland, 5021, Norway 2 Health Services Research Unit, Akershus University Hospital, Lørenskog, Akershus, 1478, Norway 3 Centre for Medical Ethics, University of Oslo, Oslo, Oslo, 0318, Norway 4 Division of Psychiatry, Haukeland University Hospital, Bergen, Hordaland, 5021, Norway 5 Department of Clinical Medicine, University of Bergen, Bergen, Hordaland, 5007, Norway 6 Mohn Research Center for Psychotic Disorders, Haukeland University Hospital, Bergen, Hordaland, 5021, Norway 7 Ragnar Frisch Centre for Economic Research, Oslo, Oslo, 0349, Norway 8 Orygen, Parkville, Victoria, 3052, Australia 9 Centre for Youth Mental Health, The University of Melbourne, Melbourne, Victoria, 3010, Australia 10 Centre for Research and Education in Forensic Psychiatry, Haukeland University Hospital, Bergen, Hordaland, 5021, Norway 11 Centre for Work and Mental Health, Nordland Hospital Trust, Bodø, Nordland, 8092, Norway 12 South West London and St George's Mental Health NHS Trust, London, SW17, UK 13 Care Policy and Evaluation Centre, Department of Health Policy, The London School of Economics and Political Science, London, England, WC2A 2AE, UK 14 Oslo Metropolitan University Faculty of Health Sciences, Oslo, Oslo, 0167, Norway 15 Centre for Care research, University of South-eastern Norway, Porsgrunn, 3918, Norway 16 Helse Førde Hospital Trust, Førde, Sogn og Fjordane, 6807, Norway 17 UiT The Arctic University of Norway, Tromsø, Troms, 9019, Norway 18 Division for Health Services, Norwegian Institute of Public Health, Oslo, Oslo, 0473, Norway Olav Nyttingnes Roles: Conceptualization, Methodology, Writing – Original Draft Preparation Tore Hofstad Roles: Conceptualization, Methodology, Visualization, Writing – Review & Editing Erik Johnsen Roles: Methodology, Writing – Review & Editing Maria Fagerbakke Strømme Roles: Methodology, Writing – Review & Editing Simen Markussen Roles: Methodology, Writing – Review & Editing Eóin Killackey Roles: Methodology, Writing – Review & Editing Miles Rinaldi Roles: Methodology, Writing – Review & Editing Anne Alnes Blindheim Roles: Methodology, Writing – Review & Editing David McDaid Roles: Methodology, Writing – Review & Editing Beate Brinchmann Roles: Methodology, Writing – Review & Editing Ingvar Bjelland Roles: Methodology, Writing – Review & Editing Jorun Rugkåsa Roles: Methodology, Writing – Review & Editing Trond Fjetland Aarre Roles: Methodology, Writing – Review & Editing Knut Rypdal Roles: Conceptualization, Writing – Review & Editing Arnstein Mykletun Roles: Conceptualization, Funding Acquisition, Methodology, Project Administration, Writing – Review & Editing OPEN PEER REVIEW REVIEWER STATUS AWAITING PEER REVIEW Abstract Background Antipsychotics are effective in reducing acute psychotic symptoms and preventing relapse in stabilized patients. However, their use remains controversial due to significant side effects and limited efficacy in some patients. This controversy is further compounded by some patients’ preferences to avoid or discontinue use, and the practice of involuntary admissions and antipsychotic medication treatment. Evaluating long-term outcomes, optimal discontinuation strategies, and the risks associated with managing first-episode psychosis without antipsychotics is challenging in randomized controlled trials (RCTs) due to ethical and safety concerns, participant attrition, and feasibility constraints. Real-world clinical practices vary widely in the duration, type, and non-use of antipsychotics due to provider variation. Methods We present a study that will utilize and link multiple longitudinal Norwegian national registry datasets, encompassing mental health care use, prescriptions, hospital emergency care contacts, injury presentations, educational outcomes, employment, criminal justice system contacts, and mortality. These data will enable descriptive analyses of outcomes for patients receiving different types, dosages, durations, and total exposures to antipsychotics, as well as for patients managed without antipsychotics. We also plan to estimate variations in public spending and societal costs. Variation in prescriber preferences will serve as quasi-randomization, allowing for causal inference after testing assumptions. Conclusions This study will provide empirical evidence to inform patients, carers, service providers, and policymakers in making complex decisions about antipsychotic maintenance treatment. Ethics and dissemination Ethic approval was granted by the Regional Ethical Committee for Medical and Health Services Research, Norway (REC South East, Committee D, REK 10895). Data will be pseudonymized for the project. The project group is committed to publishing all relevant findings in peer-reviewed journals, including null findings. READ ALL READ LESS Keywords Psychiatric epidemiology, Antipsychotics, Geographical variation, Instrumental variables, Registry studies Corresponding Author(s) Arnstein Mykletun ( [email protected] ) Close Corresponding author: Arnstein Mykletun Competing interests: No competing interests were disclosed. Grant information: This study is funded by a grant from The Research Council of Norway, Grant number: 326407. The funding agency had no role in the preparing of this protocol. The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript. Copyright: © 2025 Nyttingnes O et al . This is an open access article distributed under the terms of the Creative Commons Attribution License , which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. How to cite: Nyttingnes O, Hofstad T, Johnsen E et al. Study protocol for Controversies in psychiatry – antipsychotics: Long term outcomes and causal modelling of antipsychotic treatment using Norwegian Registry data [version 1; peer review: awaiting peer review] . F1000Research 2025, 14 :672 ( https://doi.org/10.12688/f1000research.166156.1 ) First published: 07 Jul 2025, 14 :672 ( https://doi.org/10.12688/f1000research.166156.1 ) Latest published: 07 Jul 2025, 14 :672 ( https://doi.org/10.12688/f1000research.166156.1 ) Introduction “Controversies in Psychiatry” is an umbrella project designed to generate new insights into the prognosis and treatment of severe mental disorders. This protocol encompasses work packages examining the effects of variations in the type and duration of antipsychotic treatment, as well as the outcomes of care without antipsychotics in outpatient settings for non-affective psychotic disorders. Other protocols address controversies surrounding diagnosis and medication of attention deficit hyperactivity disorder 1 and involuntary care. 2 Evidence shows that antipsychotic medications reduce acute psychotic symptoms in both the short and intermediate term. 3 Different compounds exhibit variations in efficacy, with clozapine showing the most significant benefits, followed by amisulpride and olanzapine. 4 Evidence also indicates that maintenance treatment for stabilized patients reduces relapse rates over 24 months compared to switching to placebo. 5 Clinical and patient experience indicate a higher risk of relapse when discontinuing abruptly, 6 supported by theoretical notions of brain adaptations to antipsychotic exposure. 7 However, studies indicate that both dose reductions and gradual discontinuation show a higher risk of relapse than continuing on the same dose. 5 , 8 – 10 Descriptive studies on relapse risk following varying lengths of maintenance treatment indicate either a lower 11 or higher 12 risk when discontinuing sooner after discharge from the first episode admission, though these studies differ in their analytical approaches. Consequently, guidelines unequivocally include recommendations for the use of antipsychotic medication for acute psychotic episodes and maintenance treatment. 13 – 15 For maintenance treatment, guidelines now often advise some degree of dose reduction after the acute phase, 16 including the Norwegian treatment guideline for psychotic disorders, 14 contrary to empirical findings. 8 , 9 Regrettably, unwanted side effects are common across all antipsychotic medications, 17 , 18 with certain drugs more strongly associated with specific adverse effects, such as olanzapine with weight gain and clozapine with sedation. 19 Additionally, many patients do not experience the intended symptom relief, 20 including ¾ of those with long-lasting schizophrenia. 3 Half of the patient reports in online free-text responses tells of negative experiences with antipsychotics, 21 and some patients seek to improve their subjective well-being by discontinuing antipsychotics, 22 or advocate for care arrangements without antipsychotics. 23 There are studies and case reports indicating that some patients can do well with reduced, minimal, or no antipsychotic use, 24 – 28 but studies are few, with small samples, and information from larger studies is needed. Mental health acts often mandate antipsychotic treatment against the patient’s will due to the severity of the disorder, 29 – 31 and informal persuasion and pressure for antipsychotics can also be frequent and strong. 32 , 33 This adds complexity and controversy to antipsychotic treatment. We can therefore expect differences between recommendations and observed antipsychotic consumption in patients. Indeed, a national registry study from Finland reported that 36% of patients chose non-use after discharge from their first episode admission. 34 Audits and large scale studies have shown variation in type, dose and antipsychotic polypharmacy within jurisdictions or regions 35 , 36 ; thus we expect antipsychotic prescription patterns to vary within countries. Controversy The situation can be depicted as a controversy where practice and recommendations can be arranged on a dimension from liberal to restrictive. The liberal position is concerned about under-treatment, and those concerned may recommend early initiation, higher or stable doses, or longer or permanent maintenance treatment, and warn strongly against practices such as treatment without antipsychotics. In contrast, the restrictive position, concerned about over-treatment and side effects, advocates for lower doses, shorter maintenance periods, or more frequent acceptance of care without antipsychotic treatment. Controversies tend to fade when faced with convincing evidence, particularly from randomized controlled trials (RCT), which excel in acceptability and feasibility for short to intermediate causal effects of medications. In antipsychotic care, the controversy partly concerns long-term maintenance treatment and the feasibility and safety of managing psychotic disorders without starting antipsychotics at all. Randomizing to care without medication has been challenging due to ethical and practical considerations. 37 , 38 Randomization for extended exposure time raises ethical concerns, increases trial costs, and complicates recruitment and retention. Strong patient opinions and difficulties in recruiting participants willing to consent to randomization have posed challenges in recent studies on the gradual discontinuation of antipsychotic treatment. 39 Some restrictive proponents have also argued that RCT evidence where patients are blinded to stable dose or a more or less abrupt discontinuation without compensatory measures, have limited relevance for patients that carefully plan to gradually discontinue antipsychotics. 40 Furthermore, potential selection bias is a significant issue in RCT samples of individuals with psychosis, as 80% of the general care population is excluded due to elaborate inclusion and exclusion criteria. 41 Making use of nationwide registry studies for causal analysis could mitigate these issues and provide pertinent evidence. When care ingredients vary between providers or areas, causal analyses with registry data may be possible. A recent mental health atlas reported large variations for several care parameters in Norway. 42 Consequently, we anticipate variation in relevant parameters for this study, such as prescribers’ preference for type, dosage and length of antipsychotic treatment. We also expect that some providers give patients strong warnings against treatment outside guidelines, such as not using antipsychotics, while others will be more tolerant to such patient preferences. Methods Aims This paper presents an overview of how we aim to study the relation between use of antipsychotic medication and future social outcomes and health care use, following an inpatient episode or a new psychotic episode diagnosed in outpatient care. Specifically, we aim to address the following research questions: 1. What are the long-term health and social outcomes associated with the use of different types of antipsychotic medications in outpatient care? 2. What are the long-term health and social outcomes associated with varying antipsychotic dosages in outpatient care? 3. What are the long-term health and social outcomes associated with the duration of antipsychotic exposure in outpatient care? 4. What are the long-term health and social outcomes associated with the total antipsychotic exposure during the first three years of treatment? 5. What are the long-term health and social outcomes associated with care without antipsychotic medication for patients experiencing their first psychotic episode? These questions aim to provide comprehensive insights into the effects of different treatment approaches on the well-being and outcomes of individuals diagnosed with psychosis. Setting and context The study is set in Norway, a sparsely populated northern European country with approximately 15 inhabitants per square kilometer. The public health care system is predominantly funded by tax revenues and serves as the primary provider of services for severe mental disorders, with few alternatives existing outside this single-payer system. Norway benefits from several comprehensive health, care, demographic, and social registries, which utilize unique social security numbers to facilitate highly complete and linkable data. Long distances and mountainous terrain have stimulated regional and local adaptation and self-determination, and recruitment of qualified staff is difficult in some areas. We therefore expect local providers to vary in their care preferences, and that this also influences antipsychotic treatment decisions. Which provider you happen to get, can therefore set the stage for a lottery-like situation for parts of the treatment choice, in addition to variation predicted by patient characteristics such as symptom load and treatment history. Study population and data acquisition The study will have access to data for all patients aged 10 years and older who received specialist mental or addiction health care between 2015 and 2016, estimated to be approximately 300,000 individuals. These patients will be identified through the Norwegian Patient Registry (NPR), which contains reliable, patient-identifiable national data for specialist inpatient and outpatient care with high completeness. 43 A similarly sized control cohort matched on age and sex will be drawn from the general population by the National Population Register. For both the patient and control cohorts, we will borrow individually linked data on their health care use and social status from the age of 10 onwards, for the years 2010 to 2025, from the Norwegian Patient Registry (NPR), Norwegian Prescribed Drug Registry (LMR), Central Population Register (CPR), Norwegian Registry for Primary Health Care (KPR), Norwegian Cause of Death Registry (DÅR), Norwegian Control and Health Reimbursements Register (KUHR), Central Penal and Police Register (SSP), Norwegian Education Database (NUDB), and Tax, Income and Welfare Registry (FD-trygd). The structure of data in time is illustrated in Figure 1 . Diagnoses for severe mental disorders in the NPR are found to be valid, 44 and consultations, admissions and collected prescriptions, which are reimbursed, are registered with high accuracy. This protocol regards the subsample of patients diagnosed with non-affective psychotic disorders (ICD F20-29). In 2015, the number of patients with these disorders aged 18-65 in Norway treated in specialist mental health care was 11,000. 45 Analyses for diagnostic subgroups, such as schizophrenia (F20), can be conducted when the sample size permits. Data for adolescents under 18 and for at least five years of pre-exposure (2010-2014) will be available, allowing us to distinguish incident from prevalent cases and to control for some pre-exposure function and treatment variables. Figure 1. Overview of available variables from Norwegian registries for Controversy in Psychiatry – Antipsychotic medications. Exposures and outcomes We will define exposures using data from the Norwegian Prescribed Drug Registry. Table 1 provides an overview of the planned exposures and outcomes. Antipsychotic use will be classified based on the Anatomical Therapeutic Chemical (ATC) classification N05A 46 excluding lithium. We will estimate the consumption of collected prescriptions using the Prescription Drug Purchases to Drug Use Periods (PRE2DUP) method. 47 Initial outpatient antipsychotic use and non-use will be determined after a 30-day period following discharge, as in J Tiihonen, A Tanskanen and H Taipale 11 or a similar period following an outpatient consultation where the patient has been given a new non-affective psychotic disorder diagnosis. Table 1. Planned exposures, predictors and outcomes in controversy in psychiatry – antipsychotics. Exposure Predictors Outcomes Type of antipsychotic collected by the patient in outpatient care Predictors of the type (age, sex, diagnosis, inpatient vs outpatient initiation of antipsychotic, severity indicators) Treatment discontinuation by type of antipsychotic. Health, functional and social outcomes Dose level and dosage pattern for antipsychotics collected by the patient in outpatient care Predictors of the dose (age, sex, diagnosis, outpatient initiation of antipsychotic, severity indicators, type) Stability of the dose, treatment failure by dose level. Health, functional and social outcomes Duration of antipsychotic outpatient care after a psychotic episode Predictors of duration (age, sex, diagnosis, inpatient vs outpatient initiation of antipsychotic, severity indicators, type, dose) Health, social and functional outcomes Total exposure to antipsychotics in the first three years during/after a psychotic episode 1 Predictors of total exposure (age, sex, diagnosis, inpatient vs outpatient initiation of antipsychotic, severity indicators, type, dose) Health, social and functional outcomes Outpatient care for a first psychotic episode with versus without antipsychotic medication Frequency and predictors of care without antipsychotic medications (age, sex, severity indicators) Outpatient contacts, treatment failure, other health, social and functional outcomes 1 Inpatient antipsychotic use will be estimated based on outpatient use and existing research findings. Nordic prescription registries lack data on hospital medications. 48 This limitation hinders the ability to detail medications administered in hospital or clinic settings, for example during admissions or under community treatment orders. It is reasonable to expect that the majority, but not all, patients in such care are treated with antipsychotics. 49 , 50 Consequently, if a patient does not collect any antipsychotic prescription after discharge or revocation of their community treatment order, it often signifies an abrupt discontinuation of antipsychotic medication. Therefore, this study will focus on exposures in outpatient care or make assumptions regarding inpatient antipsychotic use. The dataset will include data on various outcomes such as injuries and deaths, emergency room visits, mental health diagnoses, inpatient and outpatient care, involuntary care status, educational attainment, occupational income, welfare reliance, supported housing, and crime. Some of the functional outcomes, such as education, work participation, welfare benefits and deaths, are mainly relevant as intermediate and long-term outcomes (see Figure 1 ). For all exposures and outcomes, we will report results from observational analyses comparing patients with and without the specified exposure, as well as comparisons with the control cohort. We will control for pre-exposure indicators of severity and functioning, including prior specialist mental health care for non-psychotic disorders, injuries, education, and income. Additionally, variations in public purse and societal costs dependent on exposure can also be estimated, with appropriate local unit costs attached to resource use, and results reported in a common price year. Instrumental variable analyses We plan to estimate the causal effects of the antipsychotic exposures listed in Table 1 using variation in prescribers’ preferences as an instrumental variable. For the use of a particular antipsychotic substance, dose, or treatment duration, the instrument will be constructed based on each prescriber’s empirical frequency of administering these treatments. We will use the leave-one-out mean to ensure independence between the patient and the instrument. 51 The extent of variation in Norwegian prescribers’ preferences for the exposures in Table 1 is currently unknown and must be examined empirically. Given the situation and controversies outlined in the introduction and methods sections, along with the lack of ubiquitous treatment guidelines for several exposures, we expect sizeable variation in these exposures among prescribers. This variation should result in a strong correlation between the instrument and the exposures, which is important to avoid bias 52 and ensure a valid instrumental variable analysis. 53 We expect most patients to be unaware of professional disagreements, thus remaining blind to local or individual practice variations. Consequently, it is unlikely that patients can select prescribers based on accurate knowledge of individual prescription patterns. Prescribers’ use of various exposures will also be partly influenced by their case mix. Therefore, we will include baseline covariates such as demographics and pre-inclusion mental health treatment in our analyses. Two other important assumptions for instrumental variable analysis that must be theoretically justified are exclusion restriction and non-confounding. Exclusion restriction requires that the instrument influences the outcome only through the exposure and not through other causal pathways. We expect that the propensity for the antipsychotic exposures does not affect outcomes through other causal paths. Psychosis care without antipsychotics will be examined at the level of community mental health center catchment areas because our registry data will not allow us to allocate an individual prescriber to a patient who does not collect prescriptions. If exclusion restriction or non-confounding of the outcome is violated for care without antipsychotics at the community mental health center level, we anticipate that the instrument will predict a specific outcome beyond the patient sample. To explore this possibility, we will employ the zero-first-stage test on the control population. 54 For non-confounding, we will investigate observed variables that could potentially confound the relationships between the instrument and outcome. Several of these variables will also be controlled for as baseline covariates. If the conditions necessary for instrumental variable analyses are uncertain or not met, alternative analytical approaches will be considered, such as hierarchical models and inverse probability weighting. The power of the instrumental variable analysis will depend on several currently unknown parameters, including the magnitude of relevant covariates and the variation among prescribers for each exposure. MA Hernán 55 argued that in causal analysis with observational data, the objective is to estimate a range of effect estimates that are highly compatible with data. Consequently, even studies considered “underpowered” that yield a broad range of estimates should be conducted and published. This approach makes results available for future meta-analyses aimed at reducing uncertainty by integrating data from multiple sources. Public and patient involvement The study is presented at https://www.helse-bergen.no/avdelinger/psykisk-helsevern/forskingsavdelinga-divisjon-psykisk-helsevern/populasjonshelse/antipsykotika/ . The exposures and outcomes detailed in Table 1 , along with the broader analysis plan, have been discussed with individuals with lived experience on several occasions during the project’s development and planning phases. The current paper has undergone critical review by a co-author with lived experience (AB). Ethical approval The study protocol has been approved by the Regional Committee for Medical Research Ethics South East Norway, Committee D (REK 10895), from 2022 to 2030. The committee determined the project to be of significant utility, ensuring the welfare and integrity of participants. Patient consent and confidentiality The study will use registry data collected for administrative purposes. According to Norwegian legislation, permission can be given to research institutions to borrow and analyse de-identified data from existing health registries and other registries without individual consent, as long as participants’ welfare and integrity are maintained. Individual informed written or oral consent was deemed to be infeasible by the Regional Committee for Medical Research Ethics South East Norway. The Norwegian Directorate of e-health has approved the use of pseudonomized data for the aims of the project (H-398/S-84DD4B7E). A Data Protection Impact Assessment (DPIA) has been conducted and will be updated as necessary. The study adheres to the Declaration of Helsinki. When this manuscript was first submitted, we were still awaiting data delivery. The NPR will identify the cohort, while Statistics Norway will draw a control cohort from the remaining population, matched by age and sex, and assign each person a project-specific pseudonym number. Various registries will lend out data based on social security numbers; however, the researchers will only receive pseudonymized data. Statistics Norway will retain the linkage key for a second wave of outcome data. The project will securely store and analyze data on protected servers, accessible only to researchers approved by the Norwegian Regional Ethics Committee. Discussion This protocol outlines a naturalistic registry study of antipsychotic treatment, aiming to examine the intermediate and long-term outcomes associated with outpatient antipsychotic medication use. We acknowledge a common limitation of prescription registries: they often lack data on medication use during hospital admissions and under Community Treatment Orders (CTOs). As a result, exposures are either restricted to outpatient care, rely on assumptions about the likelihood of antipsychotic use during inpatient care and CTOs based on existing studies, or exclude patients with inpatient treatment during the exposure-defining episode. If the data properties comply with assumptions and instrumental variables or other causal approaches can be used, the results may fall into one of three main types, which can vary between both exposures and outcomes. Results may favor the exposure in question, such as a long duration of antipsychotic treatment following a psychotic episode, or the alternative, a shorter duration. A third type of result could be null findings, indicating that the exposure neither benefits nor harms the patient group. In this latter case, greater emphasis can be placed on patient preferences, the less extensive exposure, or other care elements likely to promote the treatment alliance in applied practice. Every country’s mental health care system and patient population have their particularities, which can limit the generalizability of findings. 56 The controversies surrounding antipsychotic care are present in many countries, and we expect the results to reflect the general effects of antipsychotic medications on human brains and bodies across nations. However, local prescribing practices may vary. We expect prescribers to have preferences regarding different antipsychotic prescribing methods. We also acknowledge that we, as researchers, may have our own experiences, preferences, and opinions. Our project group comprises individuals with varying assumptions about the benefits and harms of antipsychotic medication. We strive for more and better empirical evidence to inform prescribers and patients in their decisions about antipsychotic treatment strategies. Thus, we remain open to the range of possible results and are committed to publish all findings in international peer-reviewed journals, including null findings. Authors’ contributions AM, the Principal Investigator for the project, was responsible for conceptualisation, funding acquisition, supervision, and data management. KR contributed with conceptualisation and ethical guidance. ON and TH contributed with conceptualization, methodology. ON wrote the original draft, with inputs from AM and TH. SM and TH made special contributions to formal analysis, and EJ, EK, IB, MFS, and TA critically discussed and gave input on methodology in psychopharmacology and in deciding exposures in oral discussions and paper revisions. BB, EK, IB, JR, MR and TA similarly contributed to methodology as regards dose reduction and care without antipsychotics. AB discussed the project, revised the manuscript regarding exposures, outcomes, and terminology using expertise based on lived experience. DMD contributed to health economics methodology, consistency, and terminology. All authors contributed to the manuscript’s intellectual content, critically revised several iterations of the manuscript, and approved the final version. Data availability No data is used in this publication. The legal provision for the data that will be used in the project restricts data availability to a few pre-approved researchers and analyses of pre-approved research questions. 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PubMed Abstract | Publisher Full Text Comments on this article Comments (0) Version 1 VERSION 1 PUBLISHED 07 Jul 2025 ADD YOUR COMMENT Comment Author details Author details 1 Centre for Population Health, Haukeland University Hospital, Bergen, Hordaland, 5021, Norway 2 Health Services Research Unit, Akershus University Hospital, Lørenskog, Akershus, 1478, Norway 3 Centre for Medical Ethics, University of Oslo, Oslo, Oslo, 0318, Norway 4 Division of Psychiatry, Haukeland University Hospital, Bergen, Hordaland, 5021, Norway 5 Department of Clinical Medicine, University of Bergen, Bergen, Hordaland, 5007, Norway 6 Mohn Research Center for Psychotic Disorders, Haukeland University Hospital, Bergen, Hordaland, 5021, Norway 7 Ragnar Frisch Centre for Economic Research, Oslo, Oslo, 0349, Norway 8 Orygen, Parkville, Victoria, 3052, Australia 9 Centre for Youth Mental Health, The University of Melbourne, Melbourne, Victoria, 3010, Australia 10 Centre for Research and Education in Forensic Psychiatry, Haukeland University Hospital, Bergen, Hordaland, 5021, Norway 11 Centre for Work and Mental Health, Nordland Hospital Trust, Bodø, Nordland, 8092, Norway 12 South West London and St George's Mental Health NHS Trust, London, SW17, UK 13 Care Policy and Evaluation Centre, Department of Health Policy, The London School of Economics and Political Science, London, England, WC2A 2AE, UK 14 Oslo Metropolitan University Faculty of Health Sciences, Oslo, Oslo, 0167, Norway 15 Centre for Care research, University of South-eastern Norway, Porsgrunn, 3918, Norway 16 Helse Førde Hospital Trust, Førde, Sogn og Fjordane, 6807, Norway 17 UiT The Arctic University of Norway, Tromsø, Troms, 9019, Norway 18 Division for Health Services, Norwegian Institute of Public Health, Oslo, Oslo, 0473, Norway Olav Nyttingnes Roles: Conceptualization, Methodology, Writing – Original Draft Preparation Tore Hofstad Roles: Conceptualization, Methodology, Visualization, Writing – Review & Editing Erik Johnsen Roles: Methodology, Writing – Review & Editing Maria Fagerbakke Strømme Roles: Methodology, Writing – Review & Editing Simen Markussen Roles: Methodology, Writing – Review & Editing Eóin Killackey Roles: Methodology, Writing – Review & Editing Miles Rinaldi Roles: Methodology, Writing – Review & Editing Anne Alnes Blindheim Roles: Methodology, Writing – Review & Editing David McDaid Roles: Methodology, Writing – Review & Editing Beate Brinchmann Roles: Methodology, Writing – Review & Editing Ingvar Bjelland Roles: Methodology, Writing – Review & Editing Jorun Rugkåsa Roles: Methodology, Writing – Review & Editing Trond Fjetland Aarre Roles: Methodology, Writing – Review & Editing Knut Rypdal Roles: Conceptualization, Writing – Review & Editing Arnstein Mykletun Roles: Conceptualization, Funding Acquisition, Methodology, Project Administration, Writing – Review & Editing Competing interests No competing interests were disclosed. Grant information This study is funded by a grant from The Research Council of Norway, Grant number: 326407. The funding agency had no role in the preparing of this protocol. The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript. Article Versions (1) version 1 Published: 07 Jul 2025, 14:672 https://doi.org/10.12688/f1000research.166156.1 Copyright © 2025 Nyttingnes O et al . This is an open access article distributed under the terms of the Creative Commons Attribution License , which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. Download Export To Sciwheel Bibtex EndNote ProCite Ref. 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