Early Medication Discontinuation and Long-term Clinical Outcome in FEP

NCT01926340 | Completed DMC

• 1 other identifier: RPS FU study
• Study Type: observational
• Target: 178
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Schizophrenia

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Social and occupational functioning

  In one month previous to the final assessment

Other Outcomes (2)

• Relapse

  During the randomized phase of the study

• Quality of life

  In one month previous to the final assessment

Study Arms (2)

Early maintenance treatment group

Drug (quetiapine, 400mg/d) during the 12-month randomized phase of the study

Early discontinuation group

Drug (placebo) during the 12-month randomized phase of the study

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• Professor Eric Y.H. Chen: lead
• Research Grants Council, Hong Kong: collaborator
• AstraZeneca: collaborator
• Food and Health Bureau, Hong Kong: collaborator
• University of British Columbia: collaborator

Study Sites (1)

Research Site

Hong Kong, Hong Kong

Location

Related Publications (1)

• 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.

  PMID: 29551618 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

whole blood

MeSH Terms

Conditions

Schizophrenia

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Study Officials

• Eric YH Chen, MD

  The University of Hong Kong

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: July 2, 2013
• First Posted: August 20, 2013
• Study Start: November 1, 2013
• Primary Completion: December 1, 2014
• Study Completion: March 1, 2015
• Last Updated: August 7, 2017

Record last verified: 2017-08

Locations

HK (1)