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A 20-Year Follow-up of First Episode Psychosis: Longitudinal Effects of Early Treatment Strategies and Relapse

23. června 2026 aktualizováno: 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.

Přehled studie

Postavení

Nábor

Podmínky

Schizofrenie

Detailní popis

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.

Typ studie

Pozorovací

Zápis (Odhadovaný)

178

Kontakty a umístění

Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.

Studijní kontakt

Jméno: Lai Ming Christy Hui, PhD
Telefonní číslo: 852-22554486
E-mail: christy@lmhui.com

Studijní místa

Čína
- - Hong Kong, Čína
    - Nábor
    - Department of Psychiatry, Queen Mary Hospital
    - Kontakt:
      
      Christy Lai-ming Hui, Dr
      
      Telefonní číslo: +852 2255 3064
      
      E-mail: christy@lmhui.com

Kritéria účasti

Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.

Kritéria způsobilosti

Věk způsobilý ke studiu

Dospělý
Starší dospělý

Přijímá zdravé dobrovolníky

Metoda odběru vzorků

Vzorek nepravděpodobnosti

Studijní populace

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.

Popis

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

Studijní plán

Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.

Jak je studie koncipována?

Detaily designu

Počet skupin / kohort

Kohorty a intervence

Skupina / kohorta
Skupina rané udržovací léčby Lék (quetiapin, 400 mg/den) během 12měsíční randomizované fáze studie
Skupina předčasného ukončení Lék (placebo) během 12měsíční randomizované fáze studie

Co je měření studie?

Primární výstupní opatření

Měření výsledku	Popis opatření	Časové okno
Long-term Clinical Outcome Časové okno: From enrollment to 20-year follow-up	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	From enrollment to 20-year follow-up

Sekundární výstupní opatření

Měření výsledku	Popis opatření	Časové okno
Long-term Overall Functioning Časové okno: Assessed for 6 months preceding the follow-up assessment	Evaluated using the Social and Occupational Functioning Assessment Scale (SOFAS). Lower scores reflect poorer functioning in social and work-related domains, irrespective of psychopathology	Assessed for 6 months preceding the follow-up assessment
Long-term Role Functioning Časové okno: Assessed for 6 months preceding the follow-up assessment	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	Assessed for 6 months preceding the follow-up assessment
Overall Clinical Status Časové okno: Within 6 months previous to the follow-up assessment	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	Within 6 months previous to the follow-up assessment
Long-term Psychopathology Časové okno: Within 6 months previous to the follow-up assessment	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
Long-term Positive Symptoms Časové okno: Within 6 months previous to the follow-up assessment	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	Within 6 months previous to the follow-up assessment
Long-term Negative Symptoms Časové okno: 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	Within 6 months previous to the follow-up assessment
Medication Adherence Časové okno: Within 1 month previous to the follow-up assessment	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	Within 1 month previous to the follow-up assessment
Semantic Memory and Executive Function Časové okno: 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
Verbal Working Memory Časové okno: Assessed at the follow-up assessment	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	Assessed at the follow-up assessment
Visual Working Memory and Spatial Processing Časové okno: Assessed at the follow-up assessment	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	Assessed at the follow-up assessment
Stressful Life Events Časové okno: Within 6 months previous to the follow-up assessment	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	Within 6 months previous to the follow-up assessment
Health-Related Quality of Life Časové okno: Varies according to the individual questionnaire items, ranging from the past 4 weeks to the past 12 months prior to the follow-up assessment	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	Varies according to the individual questionnaire items, ranging from the past 4 weeks to the past 12 months prior to the follow-up assessment

Spolupracovníci a vyšetřovatelé

Zde najdete lidi a organizace zapojené do této studie.

Sponzor

The University of Hong Kong

Spolupracovníci

Research Grants Council, Hong Kong

Publikace a užitečné odkazy

Osoba odpovědná za zadávání informací o studiu tyto publikace poskytuje dobrovolně. Mohou se týkat čehokoli, co souvisí se studiem.

Obecné publikace

Termíny studijních záznamů

Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.

Hlavní termíny studia

Začátek studia (Aktuální)

21. května 2026

Primární dokončení (Odhadovaný)

31. prosince 2028

Dokončení studie (Odhadovaný)

31. prosince 2028

Termíny zápisu do studia

První předloženo

13. května 2026

První předloženo, které splnilo kritéria kontroly kvality

28. května 2026

První zveřejněno (Aktuální)

1. června 2026

Aktualizace studijních záznamů

Poslední zveřejněná aktualizace (Aktuální)

26. června 2026

Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality

23. června 2026

Naposledy ověřeno

1. května 2026

Více informací

Termíny související s touto studií

Klíčová slova

Další relevantní podmínky MeSH

Další identifikační čísla studie

HKU/HA_HKW_IRB_UW25-571

Plán pro data jednotlivých účastníků (IPD)

Plánujete sdílet data jednotlivých účastníků (IPD)?

Popis plánu IPD

The data will be made available upon reasonable request, subject to ethical considerations and data privacy protections.

Informace o lécích a zařízeních, studijní dokumenty

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