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Идёт набор NCT07616999

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

Наблюдательное Schizophrenia

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
Это наблюдательное исследование: исследуемое лечение участникам по протоколу не назначают.
Кому может быть актуально
Состояния в реестре: Schizophrenia. Базовые параметры: 18 лет — 65 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Китай
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
Официальное название

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

Обзор

The study aims to address the following questions: 1. Do subgroups defined by early medication choices, relapse, and medication taken over 20 years differ in clinical, cognitive, and functional outcomes? 2. What are the long-term cognitive functioning trajectories, what factors predict these trajectories, and how do they relate to outcomes? 3. 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.

Подробное описание

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.

Первичные конечные точки

  • Long-term Clinical Outcome [Срок оценки: From enrollment to 20-year follow-up]
Вторичные конечные точки (12)
  • Long-term Overall Functioning [Срок оценки: Assessed for 6 months preceding the follow-up assessment]
  • Long-term Role Functioning [Срок оценки: Assessed for 6 months preceding the follow-up assessment]
  • Overall Clinical Status [Срок оценки: Within 6 months previous to the follow-up assessment]
  • Long-term Psychopathology [Срок оценки: Within 6 months previous to the follow-up assessment]
  • Long-term Positive Symptoms [Срок оценки: Within 6 months previous to the follow-up assessment]
  • Long-term Negative Symptoms [Срок оценки: Within 6 months previous to the follow-up assessment]
  • Medication Adherence [Срок оценки: Within 1 month previous to the follow-up assessment]
  • Semantic Memory and Executive Function [Срок оценки: Assessed at the follow-up assessment]
  • Verbal Working Memory [Срок оценки: Assessed at the follow-up assessment]
  • Visual Working Memory and Spatial Processing [Срок оценки: Assessed at the follow-up assessment]
  • Stressful Life Events [Срок оценки: Within 6 months previous to the follow-up assessment]
  • Health-Related Quality of Life [Срок оценки: Varies according to the individual questionnaire items, ranging from the past 4 weeks to the past 12 months prior to the follow-up assessment]

Критерии участия

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:

Критерии включения

  • 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.

Критерии исключения

  • 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Случай-контроль

Центры проведения

Китай · 1 центр
  • Department of Psychiatry, Queen Mary Hospital — Гонконг

Публикации

  • 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)300 PMID 29551618
  • 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. PMID 20724402

Идентификаторы

NCT: NCT07616999 · HKU/HA_HKW_IRB_UW25-571

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗