A 20-Year Follow-up of First Episode Psychosis: Longitudinal Effects of Early Treatment Strategies and Relapse

NCT07616999 | Not Yet Recruiting

• 1 other identifier: HKU/HA_HKW_IRB_UW25-571
• Study Type: observational
• Target: 178
• Locations: 1 country
• Sites: 1

Brief Summary

The study aims to address the following questions:

1. 1.Do subgroups defined by early medication choices, relapse, and medication taken over 20 years differ in clinical, cognitive, and functional outcomes?
2. 2.What are the long-term cognitive functioning trajectories, what factors predict these trajectories, and how do they relate to outcomes?
3. 3.What might be the mechanisms behind medication discontinuation and poor long-term outcome, including the roles of multiple relapses and treatment resistance after first-episode psychosis?

Conditions

Schizophrenia

Keywords

Schizophrenia; 20-year follow up

Outcome Measures

Primary Outcomes (1)

• Long-term Clinical Outcome

  Poor clinical outcome is defined categorically as any of: Persistent positive symptoms of psychosis, requirement for clozapine, or death from suicide. A good clinical outcome is defined as meeting none of the above criteria

  From enrollment to 20-year follow-up

Secondary Outcomes (12)

• Long-term Overall Functioning

  Assessed for 6 months preceding the follow-up assessment

• Long-term Role Functioning

  Assessed for 6 months preceding the follow-up assessment

• Overall Clinical Status

  Within 6 months previous to the follow-up assessment

• Long-term Psychopathology

  Within 6 months previous to the follow-up assessment

• Long-term Positive Symptoms

  Within 6 months previous to the follow-up 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 active patients at their upcoming psychiatric out-patient consultations at the hospitals to introduce the follow-up study and to obtain written informed consent.

You may not 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 at the time of original enrolment
• 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.
• 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
• Inability to provide informed consent at recruitment

Sponsors & Collaborators

• Research Grants Council, Hong Kong: collaborator
• The University of Hong Kong: lead

Study Sites (1)

The University of Hong Kong

Hong Kong, China

Location

Related Publications (2)

• 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 BACKGROUND

• Chen EY, Hui CL, Lam MM, Chiu CP, Law CW, Chung DW, Tso S, Pang EP, Chan KT, Wong YC, Mo FY, Chan KP, Yao TJ, Hung SF, Honer WG. Maintenance treatment with quetiapine versus discontinuation after one year of treatment in patients with remitted first episode psychosis: randomised controlled trial. BMJ. 2010 Aug 19;341:c4024. doi: 10.1136/bmj.c4024.

  PMID: 20724402 BACKGROUND

MeSH Terms

Conditions

Schizophrenia

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Central Study Contacts

Lai Ming Christy Hui, PhD

CONTACT

852-22554486; christy@lmhui.com

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Target Duration: 20 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: May 13, 2026
• First Posted: June 1, 2026
• Study Start: May 21, 2026
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2028
• Last Updated: June 1, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)