A 20-Year Follow-up of First Episode Psychosis: Longitudinal Effects of Early Treatment Strategies and Relapse
23 de junho de 2026 atualizado por: Dr. Christy Lai-ming Hui, The University of Hong Kong
Navigating the Longitudinal Effects of Early Treatment Strategies and Relapse on Clinical, Cognitive, and Functional Outcomes: A 20-Year Follow-up of First Episode Psychosis
The study aims to address the following questions:
- Do subgroups defined by early medication choices, relapse, and medication taken over 20 years differ in clinical, cognitive, and functional outcomes?
- What are the long-term cognitive functioning trajectories, what factors predict these trajectories, and how do they relate to outcomes?
- What might be the mechanisms behind medication discontinuation and poor long-term outcome, including the roles of multiple relapses and treatment resistance after first-episode psychosis?
Eligible patients will be invited to a one-time face-to-face interview. A trained research assistant will guide the participants through questions about their background, clinical symptoms, daily functioning, cognitive abilities, and psychological well-being.
Visão geral do estudo
Status
Recrutamento
Condições
Descrição detalhada
Schizophrenia and related psychotic disorders are highly heterogeneous, with long-term outcomes shaped by early treatment decisions. Antipsychotic medications are effective in preventing relapse, but prolonged use carries substantial side effects, and many patients discontinue in real-world settings. Evidence on the long-term impact of early discontinuation remains scarce. This project is a 20-year follow-up of a uniquely well-characterized cohort of 178 individuals with first episode psychosis (FEP), originally enrolled in a randomized controlled trial (RCT) of antipsychotic maintenance versus discontinuation after achieving sustained remission (ClinicalTrials.gov NCT00334035). At the 10-year follow-up, over 80% of the cohort were successfully reassessed, providing rare insights into long-term outcomes (ClinicalTrials.gov NCT01926340).
Eligible participants will be re-contacted for a one-time assessment including structured clinical interviews, cognitive testing, psychosocial and qualitative measures. Retrospective case-note reviews will extract longitudinal data on relapse episodes, medication use, hospitalizations, and available laboratory results.
Data will be analyzed using latent class analysis to identify subgroups, latent growth models for cognitive trajectories, and regression approaches to test predictors and outcomes.
Ethical safeguards include re-consenting all participants, pre screening/ redacting medical records to preserve rater blinding,and strict de-identification of data. This study will be conducted in accordance with the Declaration of Helsinki and relevant institutional guidelines.
By extending this landmark cohort to 20 years, the study will provide novel evidence to guide personalized treatment decisions and inform policies on long-term antipsychotic use in psychosis.
Tipo de estudo
Observacional
Inscrição (Estimado)
178
Contactos e Locais
Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.
Contato de estudo
- Nome: Lai Ming Christy Hui, PhD
- Número de telefone: 852-22554486
- E-mail: christy@lmhui.com
Locais de estudo
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Hong Kong, China
- Recrutamento
- Department of Psychiatry, Queen Mary Hospital
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Contato:
- Christy Lai-ming Hui, Dr
- Número de telefone: +852 2255 3064
- E-mail: christy@lmhui.com
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Critérios de participação
Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.
Critérios de elegibilidade
Idades elegíveis para estudo
- Adulto
- Adulto mais velho
Aceita Voluntários Saudáveis
Não
Método de amostragem
Amostra Não Probabilística
População do estudo
Trained research assistants will approach active patients at their upcoming psychiatric out-patient consultations at the hospitals to introduce the follow-up study and to obtain written informed consent.
Descrição
Participants were individuals who previously participated in a randomized controlled trial investigating medication continuation/discontinuation on relapse during first episode psychosis (ClinicalTrials.gov NCT00334035). The trial included specific inclusion and exclusion criteria, detailed as follows:
Inclusion Criteria:
- A diagnosis of schizophrenia or non-affective psychosis (schizophreniform disorder, schizoaffective disorder, brief psychotic disorder, or psychosis not otherwise specified) (DSM-IV)
- Aged 18 to 65 years at the time of original enrolment
- Had been treated with antipsychotic drugs for at least 12 months
- No history of relapse or exacerbation or had to be asymptomatic (free of positive symptoms of psychosis) at study entry.
Exclusion Criteria:
- A diagnosis of drug-induced psychosis
- Current treatment with clozapine, with mood stabilizing medications (lithium, valproate or carbamazepine) or with depot medication
- Had high risk of suicide or violence
- Inability to provide informed consent at recruitment
Plano de estudo
Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.
Como o estudo é projetado?
Detalhes do projeto
Coortes e Intervenções
Grupo / Coorte |
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Grupo de tratamento de manutenção precoce
Droga (quetiapina, 400mg/d) durante a fase randomizada de 12 meses do estudo
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Grupo de descontinuação precoce
Medicamento (placebo) durante a fase aleatória de 12 meses do estudo
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Long-term Clinical Outcome
Prazo: From enrollment to 20-year follow-up
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Poor clinical outcome is defined categorically as any of: Persistent positive symptoms of psychosis, requirement for clozapine, or death from suicide.
A good clinical outcome is defined as meeting none of the above criteria
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From enrollment to 20-year follow-up
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Long-term Overall Functioning
Prazo: Assessed for 6 months preceding the follow-up assessment
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Evaluated using the Social and Occupational Functioning Assessment Scale (SOFAS).
Lower scores reflect poorer functioning in social and work-related domains, irrespective of psychopathology
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Assessed for 6 months preceding the follow-up assessment
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Long-term Role Functioning
Prazo: Assessed for 6 months preceding the follow-up assessment
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Evaluated using the Role Functioning Scale (RFS), which assesses functioning across key domains including work productivity, independent living and self-care, relationships with immediate social networks, and relationships with extended social networks.
Higher scores indicate better functioning
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Assessed for 6 months preceding the follow-up assessment
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Overall Clinical Status
Prazo: Within 6 months previous to the follow-up assessment
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Evaluated using the Clinical Global Impression (CGI) scale, a measure of global illness severity and change in condition over time.
The scale comprises Severity and Improvement ratings, with higher scores indicating more severe current illness and worsened clinical status over the past six months, respectively
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Within 6 months previous to the follow-up assessment
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Long-term Psychopathology
Prazo: Within 6 months previous to the follow-up assessment
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Evaluated using the Positive and Negative Syndrome Scale (PANSS), which evaluates self-reported symptom severity across positive symptoms, negative symptoms, and general psychopathology domains.
Higher scores indicate greater symptom severity
|
Within 6 months previous to the follow-up assessment
|
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Long-term Positive Symptoms
Prazo: Within 6 months previous to the follow-up assessment
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Evaluated using the Scale for the Assessment of Positive Symptoms (SAPS), which evaluates self-reported symptom severity across domains including hallucinations, delusions, bizarre behavior, and formal thought disorder.
Higher scores indicate greater symptom severity
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Within 6 months previous to the follow-up assessment
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Long-term Negative Symptoms
Prazo: Within 6 months previous to the follow-up assessment
|
Evaluated using the Scale for the Assessment of Negative Symptoms (SANS), which evaluates self-reported domains including affective flattening, alogia, avolition-apathy, anhedonia-asociality, and attention-related impairment.
Higher scores indicate greater symptom severity
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Within 6 months previous to the follow-up assessment
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Medication Adherence
Prazo: Within 1 month previous to the follow-up assessment
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Evaluated using the Medication Compliance Questionnaire (MCQ), which includes subscales assessing self-reported medication-taking behaviors and medication-related attitudes.
Higher scores indicate better medication adherence and more positive attitudes toward medication
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Within 1 month previous to the follow-up assessment
|
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Semantic Memory and Executive Function
Prazo: Assessed at the follow-up assessment
|
Participants engage in a Verbal Fluency Task, where they will be asked to name as many animals as possible within one minute.
Outcomes include the counts of correct, repeated, and incorrect responses.
Higher numbers of correct responses indicate better cognitive functioning
|
Assessed at the follow-up assessment
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Verbal Working Memory
Prazo: Assessed at the follow-up assessment
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Participants engage in a Letter-Number Span Test, where they will be asked to repeat sequences of numbers and letters presented verbally by research staff in forward or backward order.
The number of items to be recalled gradually increases throughout the task.
Higher scores indicate better working memory performance
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Assessed at the follow-up assessment
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Visual Working Memory and Spatial Processing
Prazo: Assessed at the follow-up assessment
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Participants engage in a Visual Patterns Test, where they will be required to remember and reproduce visually presented geometric patterns after brief exposure.
Higher scores indicate better visual memory performance
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Assessed at the follow-up assessment
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Stressful Life Events
Prazo: Within 6 months previous to the follow-up assessment
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The Stressful Life Events (SLE) questionnaire evaluates the number of significant life events experienced (e.g., loss of a loved one, severe financial problems) and the associated level of distress reported by participants.
Higher scores indicate greater exposure to stressful events and/or higher levels of distress
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Within 6 months previous to the follow-up assessment
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Health-Related Quality of Life
Prazo: Varies according to the individual questionnaire items, ranging from the past 4 weeks to the past 12 months prior to the follow-up assessment
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Evaluated using the 36-Item Short Form Health Survey (SF-36), which includes two subscales assessing physical health and mental health across multiple domains (e.g., physical ability in fulfilling role-related tasks, bodily pain, and emotional well-being).
Higher scores indicate better perceived health status and quality of life
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Varies according to the individual questionnaire items, ranging from the past 4 weeks to the past 12 months prior to the follow-up assessment
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Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Colaboradores
Publicações e links úteis
A pessoa responsável por inserir informações sobre o estudo fornece voluntariamente essas publicações. Estes podem ser sobre qualquer coisa relacionada ao estudo.
Publicações Gerais
- Hui CLM, Honer WG, Lee EHM, Chang WC, Chan SKW, Chen ESM, Pang EPF, Lui SSY, Chung DWS, Yeung WS, Ng RMK, Lo WTL, Jones PB, Sham P, Chen EYH. Long-term effects of discontinuation from antipsychotic maintenance following first-episode schizophrenia and related disorders: a 10 year follow-up of a randomised, double-blind trial. Lancet Psychiatry. 2018 May;5(5):432-442. doi: 10.1016/S2215-0366(18)30090-7. Epub 2018 Mar 15.
- Chen EY, Hui CL, Lam MM, Chiu CP, Law CW, Chung DW, Tso S, Pang EP, Chan KT, Wong YC, Mo FY, Chan KP, Yao TJ, Hung SF, Honer WG. Maintenance treatment with quetiapine versus discontinuation after one year of treatment in patients with remitted first episode psychosis: randomised controlled trial. BMJ. 2010 Aug 19;341:c4024. doi: 10.1136/bmj.c4024.
Datas de registro do estudo
Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.
Datas Principais do Estudo
Início do estudo (Real)
21 de maio de 2026
Conclusão Primária (Estimado)
31 de dezembro de 2028
Conclusão do estudo (Estimado)
31 de dezembro de 2028
Datas de inscrição no estudo
Enviado pela primeira vez
13 de maio de 2026
Enviado pela primeira vez que atendeu aos critérios de CQ
28 de maio de 2026
Primeira postagem (Real)
1 de junho de 2026
Atualizações de registro de estudo
Última Atualização Postada (Real)
26 de junho de 2026
Última atualização enviada que atendeu aos critérios de controle de qualidade
23 de junho de 2026
Última verificação
1 de maio de 2026
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- HKU/HA_HKW_IRB_UW25-571
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
NÃO
Descrição do plano IPD
The data will be made available upon reasonable request, subject to ethical considerations and data privacy protections.
Informações sobre medicamentos e dispositivos, documentos de estudo
Estuda um medicamento regulamentado pela FDA dos EUA
Não
Estuda um produto de dispositivo regulamentado pela FDA dos EUA
Não
Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .