SchizophreniaNCT07616999
A 20-Year Follow-up of First Episode Psychosis: Longitudinal Effects of Early Treatment Strategies and Relapse
An observational study of Schizophrenia, run by The University of Hong Kong at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Schizophrenia
- How many people
- 178 participants
- Where
- 1 siteChina
- Study dates
- 21 May 2026to 31 Dec 2028
- How long will I take part?
- 20 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 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.
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Department of Psychiatry, Queen Mary Hospital
Hong Kong
Christy Lai-ming Hui, Dr, +852 2255 3064, christy@lmhui.com
About this study
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
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.
Read the 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.
- Conditions
- Schizophrenia
- Keywords
- Schizophrenia, 20-year follow up
- Medical subject headings
- Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: From enrollment to 20-year follow-up
Secondary outcomes (12)
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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: Varies according to the individual questionnaire items, ranging from the past 4 weeks to the past 12 months prior to the follow-up assessment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2026
- Study start21 May 2026
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for SchizophreniaStudies of the same condition, open and under way.
- More trials run by The University of Hong KongThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 178 participants (estimated)
- Target duration
- 20 Years
Sponsor and investigators
- Lead sponsor
- The University of Hong Kong
- Sponsor type
- University, hospital or other
- Collaborators
- Research Grants Council, Hong Kong
- Responsible party
- Principal investigator, Dr. Christy Lai-ming Hui, The University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07616999
- Sponsor's protocol ID
- HKU/HA_HKW_IRB_UW25-571
- Status last verified
- May 2026
- First submitted
- 13 May 2026
- Last updated
- 26 Jun 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The data will be made available upon reasonable request, subject to ethical considerations and data privacy protections.
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)30090-7. Epub 2018 Mar 15.
PubMed 29551618Chen 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.
PubMed 20724402
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07616999
- Acronym / sponsor ID
- HKU/HA_HKW_IRB_UW25-571
- Conditions
- Schizophrenia
- Keywords
- Schizophrenia, 20-year follow up
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 178 participants (estimated)
- Lead sponsor
- The University of Hong KongUniversity, hospital or other
- Collaborators
- Research Grants Council, Hong Kong
- Study start
- 21 May 2026 (actual)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 1 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 20 Years
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 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.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Long-term Clinical Outcome
Time frame: 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
12 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2026.
- Background: PubMed 29551618Hui 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)30090-7. Epub 2018 Mar 15.
- Background: PubMed 20724402Chen 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.
- Individual participant dataSharing planned: No. The data will be made available upon reasonable request, subject to ethical considerations and data privacy protections.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Schizophrenia, run by The University of Hong Kong at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 26 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lai Ming Christy Hui, PhD (852-22554486, christy@lmhui.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Long-term Clinical Outcome (time frame: From enrollment to 20-year follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07616999, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jun 2026.