Early Medication Discontinuation and Long-term Clinical Outcome in FEP

Schizophrenia Clinical Trial

— FEP  

Official title:

The Impact of Early Medication Discontinuation on Long-term Clinical Outcome in First Episode Psychosis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01926340
• Other study ID #: RPS FU study
• Status: Completed
• Phase: N/A
• First received: July 2, 2013
• Last updated: August 4, 2017
• Start date: November 2013
• Est. completion date: March 2015

Study information

• Verified date: August 2017
• Source: The University of Hong Kong
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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 psychotic disorders.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 178
• Est. completion date: March 2015
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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)

Related Conditions & MeSH terms

• Schizophrenia

Locations

Country	Name	City	State
Hong Kong	Research Site	Hong Kong

Sponsors (5)

Lead Sponsor	Collaborator
Professor Eric Y.H. Chen	AstraZeneca, Food and Health Bureau, Hong Kong, Research Grants Council, Hong Kong, University of British Columbia

Country where clinical trial is conducted

Hong Kong, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Relapse	Define as recurrence of positive symptoms	During the randomized phase of the study
Other	Quality of life	SF-36 physical and mental health summary scores	In one month previous to the final assessment
Primary	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)	In one month previous to the final assessment
Secondary	Social and occupational functioning	Define using employment status, social and occupational functioning score, and role functioning score	In one month previous to the final assessment