Clinical trial • Psychiatry

HALOPERIDOL for First-episode psychosis | Remitted psychosis

Clinical trial of HALOPERIDOL for First-episode psychosis | Remitted psychosis.

Overview

Trial Therapeutic Area: Psychiatry
Trial Disease: First-episode psychosis | Remitted psychosis
Drug Modality: Small molecule
Paediatric Trial: Yes

Key dates

Initial CTIS Submission Date: 15-10-2024
First CTIS Authorization Date: 25-11-2024

Trial design

Randomised, continuation of antipsychotic medication (standard care) versus early dose reduction/discontinuation of antipsychotic medication. specific antipsychotic agents used per standard care include multiple marketed antipsychotics listed in the application (e.g., haloperidol, clozapine, tiapride, sertindole, paliperidone, olanzapine, sulpiride, aripiprazole, lurasidone, risperidone, amisulpride, chlorpromazine, pimozide, quetiapine); no doses or schedules specified in the record.-controlled trial across 2 sites in Netherlands.

Randomised: Yes
Comparator: Continuation of antipsychotic medication (standard care) versus early dose reduction/discontinuation of antipsychotic medication. Specific antipsychotic agents used per standard care include multiple marketed antipsychotics listed in the application (e.g., HALOPERIDOL, CLOZAPINE, TIAPRIDE, SERTINDOLE, PALIPERIDONE, OLANZAPINE, SULPIRIDE, ARIPIPRAZOLE, LURASIDONE, RISPERIDONE, AMISULPRIDE, CHLORPROMAZINE, PIMOZIDE, QUETIAPINE); no doses or schedules specified in the record.
Target Sample Size: 444

Eligibility

Recruits 444 paediatric patients.

Vulnerable Population: Vulnerable population selected. Inclusion includes participants aged 16-60 years. Consent requirement: "The participant understands the study and is able to provide written informed consent." Sufficient command of the Dutch language is required. No information provided on parental consent or assent for minors.

Inclusion criteria

{"criterion_text":"- The participant has had a first episode of psychosis and uses antipsychotic medication.\n- Psychotic symptoms are in remission for 3-6 months.\n- Age 16-60 years.\n- The participant understands the study and is able to provide written informed consent.\n- HAMLETT is the only medical-scientific medication study in which the patient participates.\n- Sufficient command of the Dutch language."}

Exclusion criteria

{"criterion_text":"- Dangerous or harmful behaviour (i.e. behaviour with a risk of severe physical injury, or actual physical injury inflicted, to self or others) occurred during the psychosis.\n- Coercive treatment (based on a judicial ruling)."}

Endpoints

Primary endpoints

{"endpoint_text":"- 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)","definition_or_measurement_approach":"Measured using the World Health Organization's Disability Assessment Schedule (WHODAS-II) as a quantification of long-term social recovery determined important by patients and relatives (survey by Anoiksis)."}

Secondary endpoints

{"endpoint_text":"- 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.","definition_or_measurement_approach":"Includes measurement of medication side effects, personal wellbeing, quality of life, symptom severity, physical health (BMI, somatic comorbidity including metabolic syndrome), aggression/self-harm, cognitive functioning, movement disorders, number/duration of psychotic relapses and psychiatric treatments, substance use; and Ecological Momentary Assessments (EMA) and smartphone-based measures (BeHapp) for social functioning and well-being in daily life."}

Recruitment

Planned Sample Size: 444
Recruitment Window Months: 188
Consent Approach: Participants must understand the study and provide written informed consent: "The participant understands the study and is able to provide written informed consent." Sufficient command of the Dutch language is required. Subject information and informed consent form document (L1_SIS and ICF) is available. No information provided on assent or parental consent for participants under 18.

Geography

Total Number Of Sites: 2
Total Number Of Participants: 444

Netherlands

Earliest CTIS Part Ii Submission Date: 14-11-2024
Latest Decision Or Authorization Date: 25-11-2024
Processing Time Days: 11
Number Of Sites: 2
Number Of Participants: 444

Sites

Site Name: Universitair Medisch Centrum Utrecht
Department Name: Psychiatry
Contact Person Name: Iris Hamers
Contact Person Email: i.m.h.hamers@umcutrecht.nl

Site Name: Universitair Medisch Centrum Groningen
Department Name: BSCS
Contact Person Name: Jort Noorman
Contact Person Email: j.noorman@umcg.nl

Sponsor

Primary sponsor

Full Name: Universitair Medisch Centrum Groningen
Organisation Type: Hospital/Clinic/Other health care facility
Country Of Registered Address: Netherlands

Investigational products

Investigational Product Name: HALOPERIDOL
Active Substance: HALOPERIDOL
Modality: Small molecule
Routes Of Administration: Oral (tablet)
Route: Oral

Investigational Product Name: CLOZAPINE
Active Substance: CLOZAPINE
Modality: Small molecule
Routes Of Administration: Oral (tablet)
Route: Oral

Investigational Product Name: TIAPRIDE
Active Substance: TIAPRIDE
Modality: Small molecule
Routes Of Administration: Oral (tablet)
Route: Oral

Investigational Product Name: SERTINDOLE
Active Substance: SERTINDOLE
Modality: Small molecule
Routes Of Administration: Oral (film-coated tablet)
Route: Oral

Investigational Product Name: PALIPERIDONE
Active Substance: PALIPERIDONE
Modality: Small molecule
Routes Of Administration: Oral (prolonged-release tablet)
Route: Oral

Investigational Product Name: OLANZAPINE
Active Substance: OLANZAPINE
Modality: Small molecule
Routes Of Administration: Oral (tablet)
Route: Oral

Investigational Product Name: SULPIRIDE
Active Substance: SULPIRIDE
Modality: Small molecule
Routes Of Administration: Oral (tablet)
Route: Oral

Investigational Product Name: ARIPIPRAZOLE
Active Substance: ARIPIPRAZOLE
Modality: Small molecule
Routes Of Administration: Oral (tablet)
Route: Oral

Investigational Product Name: LURASIDONE
Active Substance: LURASIDONE
Modality: Small molecule
Routes Of Administration: Oral (film-coated tablet)
Route: Oral

Investigational Product Name: RISPERIDONE
Active Substance: RISPERIDONE
Modality: Small molecule
Routes Of Administration: Oral (tablet)
Route: Oral

Investigational Product Name: AMISULPRIDE
Active Substance: AMISULPRIDE
Modality: Small molecule
Routes Of Administration: Oral (tablet)
Route: Oral

Investigational Product Name: CHLORPROMAZINE
Active Substance: CHLORPROMAZINE
Modality: Small molecule
Routes Of Administration: Oral (film-coated tablet)
Route: Oral

Investigational Product Name: PIMOZIDE
Active Substance: PIMOZIDE
Modality: Small molecule
Routes Of Administration: Oral (tablet)
Route: Oral

Investigational Product Name: QUETIAPINE
Active Substance: QUETIAPINE
Modality: Small molecule
Routes Of Administration: Oral (tablet)
Route: Oral

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