NCT01926340|CompletedDMC
Early Medication Discontinuation and Long-term Clinical Outcome in FEP
FEP
The Impact of Early Medication Discontinuation on Long-term Clinical Outcome in First Episode Psychosis
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FEP
The Impact of Early Medication Discontinuation on Long-term Clinical Outcome in First Episode Psychosis
Sponsor study identifier
observational
178
1 country
1
Study Start
November 2013
Actual (reported)Primary Completion
December 2014
Actual (reported)Study Completion
March 2015
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
March 2015
Actual (reported)Click on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
July 2, 2013
Actual (reported)August 20, 2013
Actual (reported)November 2013
Actual (reported)December 2014
Actual (reported)March 2015
Actual (reported)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
Social and occupational functioning
In one month previous to the final assessment
Relapse
During the randomized phase of the study
Quality of life
In one month previous to the final assessment
Drug (quetiapine, 400mg/d) during the 12-month randomized phase of the study
Drug (placebo) during the 12-month randomized phase of the study
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.
Research Site
Hong Kong, Hong Kong
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.
whole blood
Eric YH Chen, MD
The University of Hong Kong
178 participants (actual enrollment reported by the registry).
First Submitted
July 2, 2013
First Posted
August 20, 2013
Study Start
November 2013
Actual (reported)Cost-effectiveness of Interventions in First-episode Psychosis
Contact the study team to confirm eligibility.
Primary Completion
December 2014
Actual (reported)Study Completion
March 2015
Actual (reported)Last Updated
August 7, 2017
Record last verified: 2017-08
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Source: ClinicalTrials.gov.
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