Early Medication Discontinuation and Long-term Clinical Outcome in FEP (NCT01926340) | Clinical Trial Compass
CompletedNot Applicable
Early Medication Discontinuation and Long-term Clinical Outcome in FEP
Hong Kong178 participantsStarted 2013-11
Plain-language 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 psychotic disorders.
Who can participate
Age range
18 Years – 65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
* 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
* Had poor adherence to treatment (missing\>50% of drug, \>50% missed clinic visits, or a history of medication discontinuation)
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Poor clinical outcome
Timeframe: In one month previous to the final assessment