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

2026年6月23日更新者：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.

調査の概要

状態

募集

条件

統合失調症

詳細な説明

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.

研究の種類

観察的

入学 (推定)

178

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究連絡先

名前：Lai Ming Christy Hui, PhD
電話番号：852-22554486
メール：christy@lmhui.com

研究場所

中国
- - Hong Kong、中国
    - 募集
    - Department of Psychiatry, Queen Mary Hospital
    - コンタクト：
      
      Christy Lai-ming Hui, Dr
      
      電話番号：+852 2255 3064
      
      メール：christy@lmhui.com

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

大人
高齢者

健康ボランティアの受け入れ

いいえ

サンプリング方法

非確率サンプル

調査対象母集団

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.

説明

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

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか？

デザインの詳細

グループ/コホートの数

コホートと介入

グループ/コホート
早期維持治療群研究の12か月のランダム化段階中の薬剤（クエチアピン、400mg/日）
早期中止群研究の12か月のランダム化段階中の薬物（プラセボ）

この研究は何を測定していますか？

主要な結果の測定

結果測定	メジャーの説明	時間枠
Long-term Clinical Outcome 時間枠：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

二次結果の測定

結果測定	メジャーの説明	時間枠
Long-term Overall Functioning 時間枠：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 時間枠：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 時間枠：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 時間枠：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 時間枠：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 時間枠：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 時間枠：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 時間枠：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 時間枠：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 時間枠：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 時間枠：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 時間枠：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

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

スポンサー

The University of Hong Kong

協力者

Research Grants Council, Hong Kong

出版物と役立つリンク

研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。

一般刊行物

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (実際)

2026年5月21日

一次修了 (推定)

2028年12月31日

研究の完了 (推定)

2028年12月31日

試験登録日

最初に提出

2026年5月13日

QC基準を満たした最初の提出物

2026年5月28日

最初の投稿 (実際)

2026年6月1日

学習記録の更新

投稿された最後の更新 (実際)

2026年6月26日

QC基準を満たした最後の更新が送信されました

2026年6月23日

最終確認日

2026年5月1日

詳しくは

本研究に関する用語

キーワード

追加の関連 MeSH 用語

その他の研究ID番号

HKU/HA_HKW_IRB_UW25-571

個々の参加者データ (IPD) の計画

個々の参加者データ (IPD) を共有する予定はありますか?

いいえ

IPD プランの説明

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

医薬品およびデバイス情報、研究文書

米国FDA規制医薬品の研究

いいえ

米国FDA規制機器製品の研究

いいえ

この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。