Early Medication Discontinuation and Long-term Clinical Outcome in FEP
Condition: Schizophrenia
MeSH terms: Schizophrenia
Study type: Observational

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.
    

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.
    

Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
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.
      
Biospecimen description: 
      whole blood