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
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 178
- 试验地点
- 1
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •, 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
研究组 & 干预措施
Early maintenance treatment group
Drug (quetiapine, 400mg/d) during the 12-month randomized phase of the study
Early discontinuation group
Drug (placebo) during the 12-month randomized phase of the study
研究者
Dr. Christy Lai-ming Hui
Associate Professor
The University of Hong Kong