A 20-Year Follow-up of First Episode Psychosis: Longitudinal Effects of Early Treatment Strategies and Relapse
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Schizophrenia. Basic parameters: 18 years — 65 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
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
Overview
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.
Detailed description
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.
Primary outcome measures
- Long-term Clinical Outcome [Time frame: From enrollment to 20-year follow-up]
Secondary outcome measures (12)
- Long-term Overall Functioning [Time frame: Assessed for 6 months preceding the follow-up assessment]
- Long-term Role Functioning [Time frame: Assessed for 6 months preceding the follow-up assessment]
- Overall Clinical Status [Time frame: Within 6 months previous to the follow-up assessment]
- Long-term Psychopathology [Time frame: Within 6 months previous to the follow-up assessment]
- Long-term Positive Symptoms [Time frame: Within 6 months previous to the follow-up assessment]
- Long-term Negative Symptoms [Time frame: Within 6 months previous to the follow-up assessment]
- Medication Adherence [Time frame: Within 1 month previous to the follow-up assessment]
- Semantic Memory and Executive Function [Time frame: Assessed at the follow-up assessment]
- Verbal Working Memory [Time frame: Assessed at the follow-up assessment]
- Visual Working Memory and Spatial Processing [Time frame: Assessed at the follow-up assessment]
- Stressful Life Events [Time frame: Within 6 months previous to the follow-up assessment]
- Health-Related Quality of Life [Time frame: Varies according to the individual questionnaire items, ranging from the past 4 weeks to the past 12 months prior to the follow-up assessment]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Case-control
Study locations
China · 1 center
- Department of Psychiatry, Queen Mary Hospital — Hong Kong
Publications
- 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
Identifiers
NCT: NCT07616999 · HKU/HA_HKW_IRB_UW25-571