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HAMLETT; Handling Antipsychotic Medication: Long-term Evaluation of Targeted Treatment. A pragmatic single blind RCT of continuation versus discontinuation/ dose reduction of antipsychotic medication in patients remitted after a first episode of psychosis

Status
Not yet recruiting
Phases
Phase 4
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2024-518769-80-00
Acronym
NL6220204217
Enrollment
444
Registered
2024-11-25
Start date
Unknown
Completion date
Unknown
Last updated
2024-11-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HAMLETT compares regular treatment guidelines for patients in remission after a first episode of psychosis, namely continuation with antipsychotic medication for at least one year, with early dose reduction/discontinuation.

Brief summary

Primary outcome measure is based on what patients and their relatives deemed most important as assessed in a survey conducted by Anoiksis (a Dutch patient organisation). This was a long term social recovery and is best quantified with the World Health Organization's Disability Assessment Schedule (WHODAS-II)

Detailed description

econdary outcome measures are: side effects of medication use, personal wellbeing, quality of life, symptom severity, physical health (body mass index, somatic comorbidity including metabolic syndrome), aggression and self-harm, cognitive functioning, movement disorders, number and duration of psychotic relapses, number and duration of psychiatric treatments, cigarette alcohol and drug abuse. Ecological momentary assessments (EMA) as measure of social functioning and well-being in daily life.

Interventions

DRUGHALOPERIDOL
DRUGCLOZAPINE
DRUGPALIPERIDONE
DRUGOLANZAPINE
DRUGARIPIPRAZOLE
DRUGLURASIDONE
DRUGRISPERIDONE
DRUGAMISULPRIDE
DRUGQUETIAPINE

Sponsors

Universitair Medisch Centrum Groningen
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
0 Years to 64 Years

Design outcomes

Primary

MeasureTime frame
Primary outcome measure is based on what patients and their relatives deemed most important as assessed in a survey conducted by Anoiksis (a Dutch patient organisation). This was a long term social recovery and is best quantified with the World Health Organization's Disability Assessment Schedule (WHODAS-II)

Secondary

MeasureTime frame
econdary outcome measures are: side effects of medication use, personal wellbeing, quality of life, symptom severity, physical health (body mass index, somatic comorbidity including metabolic syndrome), aggression and self-harm, cognitive functioning, movement disorders, number and duration of psychotic relapses, number and duration of psychiatric treatments, cigarette alcohol and drug abuse. Ecological momentary assessments (EMA) as measure of social functioning and well-being in daily life.

Countries

Netherlands

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026