An observational study in Schizophrenia, sponsored by The University of Hong Kong. Recruiting at 1 site in China. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-06-26.
Sponsored by The University of Hong Kong · Observational
The study aims to address the following questions:
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.
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.
3,471 studies on the registry are indexed under Schizophrenia; 472 are open to participants now.
This study's planned enrollment of 178 is close to the median of 178 across 491 observational studies indexed under Schizophrenia.
Browse Schizophrenia studies →The University of Hong Kong is the lead sponsor of 1,262 studies on the registry; 340 are open to participants now.
Of its 8 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
Counted across the registry records on this site, refreshed daily.
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.
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:
Exclusion Criteria:
Drug (quetiapine, 400mg/d) during the 12-month randomized phase of the study
Drug (placebo) during the 12-month randomized phase of the study
Long-term Clinical Outcome
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
Time frame: From enrollment to 20-year follow-up
Long-term Overall Functioning
Evaluated using the Social and Occupational Functioning Assessment Scale (SOFAS). Lower scores reflect poorer functioning in social and work-related domains, irrespective of psychopathology
Time frame: Assessed for 6 months preceding the follow-up assessment
Long-term Role Functioning
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
Time frame: Assessed for 6 months preceding the follow-up assessment
Overall Clinical Status
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
Time frame: Within 6 months previous to the follow-up assessment
Long-term Psychopathology
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
Time frame: Within 6 months previous to the follow-up assessment
Long-term Positive Symptoms
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
Time frame: Within 6 months previous to the follow-up assessment
Long-term Negative Symptoms
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
Time frame: Within 6 months previous to the follow-up assessment
Medication Adherence
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
Time frame: Within 1 month previous to the follow-up assessment
Semantic Memory and Executive Function
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
Time frame: Assessed at the follow-up assessment
Verbal Working Memory
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
Time frame: Assessed at the follow-up assessment
Visual Working Memory and Spatial Processing
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
Time frame: Assessed at the follow-up assessment
Stressful Life Events
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
Time frame: Within 6 months previous to the follow-up assessment
Health-Related Quality of Life
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
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
Plan to share: No — The data will be made available upon reasonable request, subject to ethical considerations and data privacy protections.
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