A 20-Year Follow-up of First Episode Psychosis: Longitudinal Effects of Early Treatment Strategies and Relapse
23 de junio de 2026 actualizado 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.
Descripción general del estudio
Estado
Reclutamiento
Condiciones
Descripción detallada
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 estudio
De observación
Inscripción (Estimado)
178
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Estudio Contacto
- Nombre: Lai Ming Christy Hui, PhD
- Número de teléfono: 852-22554486
- Correo electrónico: christy@lmhui.com
Ubicaciones de estudio
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Hong Kong, Porcelana
- Reclutamiento
- Department of Psychiatry, Queen Mary Hospital
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Contacto:
- Christy Lai-ming Hui, Dr
- Número de teléfono: +852 2255 3064
- Correo electrónico: christy@lmhui.com
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Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
No
Método de muestreo
Muestra no probabilística
Población de estudio
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.
Descripción
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
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
Cohortes e Intervenciones
Grupo / Cohorte |
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Grupo de tratamiento de mantenimiento temprano
Fármaco (quetiapina, 400 mg/día) durante la fase aleatoria de 12 meses del estudio
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Grupo de discontinuación temprana
Fármaco (placebo) durante la fase aleatoria de 12 meses del estudio
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Long-term Clinical Outcome
Periodo de tiempo: 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 resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Long-term Overall Functioning
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
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Within 6 months previous to the follow-up assessment
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Long-term Positive Symptoms
Periodo de tiempo: 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
Periodo de tiempo: Within 6 months previous to the follow-up assessment
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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
Periodo de tiempo: 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
Periodo de tiempo: Assessed at the follow-up assessment
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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
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Assessed at the follow-up assessment
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Verbal Working Memory
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Colaboradores
Publicaciones y enlaces útiles
La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.
Publicaciones Generales
- 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.
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Actual)
21 de mayo de 2026
Finalización primaria (Estimado)
31 de diciembre de 2028
Finalización del estudio (Estimado)
31 de diciembre de 2028
Fechas de registro del estudio
Enviado por primera vez
13 de mayo de 2026
Primero enviado que cumplió con los criterios de control de calidad
28 de mayo de 2026
Publicado por primera vez (Actual)
1 de junio de 2026
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
26 de junio de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
23 de junio de 2026
Última verificación
1 de mayo de 2026
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- HKU/HA_HKW_IRB_UW25-571
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
NO
Descripción del plan IPD
The data will be made available upon reasonable request, subject to ethical considerations and data privacy protections.
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .