Schizophrenia
Conditions
Keywords
Schizophrenia, 20-year follow up
Brief summary
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.
Interventions
None listed
Sponsors
The University of Hong Kong
Research Grants Council, Hong Kong
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Long-term Clinical Outcome | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Long-term Overall Functioning | 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 |
| Long-term Role Functioning | 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 |
| Overall Clinical Status | 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 |
| Long-term Psychopathology | 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 |
| Long-term Positive Symptoms | 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 |
| Long-term Negative Symptoms | 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 |
| Medication Adherence | 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 |
| Semantic Memory and Executive Function | 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 |
| Verbal Working Memory | 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 |
| Visual Working Memory and Spatial Processing | 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 |
| Stressful Life Events | 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 |
| Health-Related 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 | 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 |
Countries
China
Contacts
CONTACTLai Ming Christy Hui, PhD
Outcome results
None listed