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

ConditionSchizophrenia
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-65
SponsorThe University of Hong Kong

About this trial

The study aims to address the following questions:

1. Do subgroups defined by early medication choices, relapse, and medication taken over 20 years differ in clinical, cognitive, and functional outcomes? 2. What are the long-term cognitive functioning trajectories, what factors predict these trajectories, and how do they relate to outcomes? 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?

Eligible patients will be invited to a one-time face-to-face interview. A trained research assistant will guide the participants through questions about their background, clinical symptoms, daily functioning, cognitive abilities, and psychological well-being.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

None

Disqualifiers

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.

Trial 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.

Trial design

Design model

Case-control

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

178 Participants
are grouped into 2 trial groups
Group A: Early maintenance treatment group
Group B: Early discontinuation group

Trial outcomes

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

Time frame
From enrollment to 20-year follow-up

Secondary outcomes

1

Long-term Overall Functioning

Evaluated using the Social and Occupational Functioning Assessment Scale (SOFAS). Lower scores reflect poorer functioning in social and work-related domains, irrespective of psychopathology

Time frame
Assessed for 6 months preceding the follow-up assessment
2

Long-term Role Functioning

Evaluated using the Role Functioning Scale (RFS), which assesses functioning across key domains including work productivity, independent living and self-care, relationships with immediate social networks, and relationships with extended social networks. Higher scores indicate better functioning

Time frame
Assessed for 6 months preceding the follow-up assessment
3

Overall Clinical Status

Evaluated using the Clinical Global Impression (CGI) scale, a measure of global illness severity and change in condition over time. The scale comprises Severity and Improvement ratings, with higher scores indicating more severe current illness and worsened clinical status over the past six months, respectively

Time frame
Within 6 months previous to the follow-up assessment
4

Long-term Psychopathology

Evaluated using the Positive and Negative Syndrome Scale (PANSS), which evaluates self-reported symptom severity across positive symptoms, negative symptoms, and general psychopathology domains. Higher scores indicate greater symptom severity

Time frame
Within 6 months previous to the follow-up assessment

Other outcomes

Sponsors and contacts

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The University of Hong Kong

Lead sponsor

Research Grants Council, Hong Kong

Collaborator