SchizophreniaFEPNCT01926340
Early Medication Discontinuation and Long-term Clinical Outcome in FEP
An observational study of Schizophrenia, run by Professor Eric Y.H. Chen at 1 site in Hong Kong.
Trial summary
The study aims to examine the relationship between early maintenance therapy decisions in first episode psychosis, and the subsequent long-term clinical outcome at 9-10 years by comparing a group of patients who were randomized to discontinue (placebo) or continue medication (quetiapine) in the early stage of their… 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 siteHong Kong
- Study dates
- Nov 2013to Mar 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
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 patients at their upcoming out-patient consultations to introduce the follow-up study and to obtain written informed consent. Those who are not active cases in the Hong Kong Hospital Authority (HA) system will be invited by letter and telephone to participate in the study.
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
- 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
- Had poor adherence to treatment (missing>50% of drug, >50% missed clinic visits, or a history of medication discontinuation)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Impact of Early Medication Discontinuation on Long-term Clinical Outcome in First Episode Psychosis
The study aims to examine the relationship between early maintenance therapy decisions in first episode psychosis, and the subsequent long-term clinical outcome at 9-10 years by comparing a group of patients who were randomized to discontinue (placebo) or continue medication (quetiapine) in the early stage of their psychotic disorders.
Read the detailed description
Design: This is a follow up or extension to the double-blind randomized placebo-controlled 12-month study (Chen et al., BMJ 2010;341:C4024-4). At any point during the 12-month study, patients who had relapsed or discontinued would stop the study medication (quetiapine or placebo) and that would be the end point of the randomized phase of the study. After completion of the randomized phase, patients will receive clinical guideline-based, open-label treatment. Trained research assistants will approach patients at their upcoming out-patient consultations to introduce the follow-up study and to obtain their written informed consent.
Data analysis plan \& handling of missing outcome data: Statistical analyses will be carried out according to the intention-to-treat principle. The primary outcome measure of the long-term clinical outcomes (suicide, clozapine treatment, persistent positive symptoms) between the groups randomized to early treatment discontinuation (placebo) or maintenance treatment (quetiapine) will be compared using risk ratios [RR] and 95% confidence intervals [CI].
For all patients, long-term outcome assessments will include longitudinal chart review over the follow-up period indicating suicide or clozapine treatment. Positive symptom will be assessed at the 10-year face-to-face interview, or in the situations where this data is not available, will be based on the last positive symptom assessment from the randomized study. We will assess the possible effect of this approach by conducting sensitivity analyses, namely re-classifying patients with missing end-point interviews as either all good outcome, or all poor outcome. A mediation analysis will also carried out to examine whether the effects of the intervention on long-term outcome are linked to relapse during the randomized phase.
The secondary outcome measures of social and occupational functioning will be analysed using RR or independent t-tests. Standardized mortality ratios (SMRs) based on age-sex population mortality rate and age-sex suicide rate will also be calculated.
- Conditions
- Schizophrenia
- 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.
Poor clinical outcome
Define categorically as any of: persistent positive symptoms of psychosis, requirement for clozapine or death from suicide.
Good clinical outcome: meeting none of the criteria for Poor clinical outcome (as above)
Measured: In one month previous to the final assessment
Secondary outcomes (1)
Social and occupational functioning
Define using employment status, social and occupational functioning score, and role functioning score
Measured: In one month previous to the final assessment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2013 (estimated)
- Study startNov 2013
- Primary completionDec 2014
- Study completionMar 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for SchizophreniaStudies of the same condition, open and under way.
- 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 (actual)
Sponsor and investigators
- Lead sponsor
- Professor Eric Y.H. Chen
- Sponsor type
- University, hospital or other
- Collaborators
- Research Grants Council, Hong Kong, AstraZeneca, Food and Health Bureau, Hong Kong, University of British Columbia
- Responsible party
- Sponsor-investigator, Professor Eric Y.H. Chen, The University of Hong Kong
- Investigators
- Eric YH Chen, MD, Principal investigator, The University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01926340
- Sponsor's protocol ID
- RPS FU study
- Acronym
- FEP
- Status last verified
- Aug 2017
- First submitted
- 2 Jul 2013
- Last updated
- 7 Aug 2017
- Results posted
- No
- Data monitoring committee
- Yes
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 29551618
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Early Medication Discontinuation on Long-term Clinical Outcome in First Episode Psychosis
- ClinicalTrials.gov ID
- NCT01926340
- Acronym / sponsor ID
- FEP / RPS FU study
- Conditions
- Schizophrenia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 178 participants (actual)
- Lead sponsor
- Professor Eric Y.H. ChenUniversity, hospital or other
- Collaborators
- Research Grants Council, Hong Kong, AstraZeneca, Food and Health Bureau, Hong Kong, University of British Columbia
- Study start
- Nov 2013 (actual)
- Primary completion
- Dec 2014 (actual)
- Study completion
- Mar 2015 (actual)
- First posted
- 20 Aug 2013 (estimated)
- 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 examine the relationship between early maintenance therapy decisions in first episode psychosis, and the subsequent long-term clinical outcome at 9-10 years by comparing a group of patients who were randomized to discontinue (placebo) or continue medication (quetiapine) in the early stage of their psychotic disorders.
Detailed description
Design: This is a follow up or extension to the double-blind randomized placebo-controlled 12-month study (Chen et al., BMJ 2010;341:C4024-4). At any point during the 12-month study, patients who had relapsed or discontinued would stop the study medication (quetiapine or placebo) and that would be the end point of the randomized phase of the study. After completion of the randomized phase, patients will receive clinical guideline-based, open-label treatment. Trained research assistants will approach patients at their upcoming out-patient consultations to introduce the follow-up study and to obtain their written informed consent.
Data analysis plan \& handling of missing outcome data: Statistical analyses will be carried out according to the intention-to-treat principle. The primary outcome measure of the long-term clinical outcomes (suicide, clozapine treatment, persistent positive symptoms) between the groups randomized to early treatment discontinuation (placebo) or maintenance treatment (quetiapine) will be compared using risk ratios [RR] and 95% confidence intervals [CI].
For all patients, long-term outcome assessments will include longitudinal chart review over the follow-up period indicating suicide or clozapine treatment. Positive symptom will be assessed at the 10-year face-to-face interview, or in the situations where this data is not available, will be based on the last positive symptom assessment from the randomized study. We will assess the possible effect of this approach by conducting sensitivity analyses, namely re-classifying patients with missing end-point interviews as either all good outcome, or all poor outcome. A mediation analysis will also carried out to examine whether the effects of the intervention on long-term outcome are linked to relapse during the randomized phase.
The secondary outcome measures of social and occupational functioning will be analysed using RR or independent t-tests. Standardized mortality ratios (SMRs) based on age-sex population mortality rate and age-sex suicide rate will also be calculated.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- 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 patients at their upcoming out-patient consultations to introduce the follow-up study and to obtain written informed consent. Those who are not active cases in the Hong Kong Hospital Authority (HA) system will be invited by letter and telephone to participate in the study.
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
- 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
- Had poor adherence to treatment (missing>50% of drug, >50% missed clinic visits, or a history of medication discontinuation)
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
Poor clinical outcome
Time frame: In one month previous to the final assessment
Define categorically as any of: persistent positive symptoms of psychosis, requirement for clozapine or death from suicide. Good clinical outcome: meeting none of the criteria for Poor clinical outcome (as above)
1 secondary outcome
Social and occupational functioning
Time frame: In one month previous to the final assessment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2017.
- Derived from this study: 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.
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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. This study is not recruiting at the moment.
Eric YH Chen, MD principal investigator
The University of Hong Kong
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 Professor Eric Y.H. Chen at 1 site in Hong Kong.
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: finished, as of the sponsor's last update on 7 Aug 2017. 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 Hong Kong. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Poor clinical outcome (time frame: In one month previous to the final assessment). 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 NCT01926340, which also lists 1 linked publication.
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 7 Aug 2017.