Schizophrenia Clinical Trial
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.
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.
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