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

Start 25 Nov 2024 · Status Ongoing, recruitment ended · 1 EU/EEA countries · 2 sites · Protocol NL6220204217

Overview

Sponsor-declared trial summary

Phase Therapeutic use (Phase IV)

Status Ongoing, recruitment ended

Participants planned 444

Countries 1

Sites 2

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.

The HAMLETT study investigates the effects of maintenance treatment versus discontinuation/dose reduction of antipsychotic medication after remission of first episode psychosis on personal and social functioning, This question not only concerns short-term effects (i.e. 1 or 2 years), but also long-term functioning (3-4…

Key facts

Sponsor: Universitair Medisch Centrum Groningen
Participant type: Pediatric, Patients
Age range: 0-17 years, 18-64 years
Gender: Male and Female
Therapeutic area: Psychiatry and Psychology [F] - Mental Disorders [F03]
Trial duration: 25 Nov 2024 → ongoing
Decision date (initial): 2024-11-25
Transition trial: Yes
Low-intervention: No
Rare-disease indication: No
Vulnerable population: Yes

External identifiers

EU CT number: 2024-518769-80-00
EudraCT number: 2017-002406-12

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Therapy, Efficacy, Dose response

Secondary objectives 1

HAMLETT also evaluates psychotic symptom severity, health-related quality of life, cognitive functioning, speech production, amongst a range of other relevant outcomes. Optional components include Ecological momentary assessments (EMA) and the BeHapp application via the smartphone.

Conditions and MedDRA coding

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 6

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

Exclusion criteria 2

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.
Coercive treatment (based on a judicial ruling).

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

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 endpoints 1

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.

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 14

Aripiprazole

SUB05564MIG · Substance

Active substance: Aripiprazole
Pharmaceutical form: TABLET
Route of administration: APPLICATION
Max daily dose: 999
Max total dose: 999
Max treatment duration: 999 Week(s)
Authorisation status: Authorised
ATC code: - — -
Marketing authorisation: -
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Olanzapine

SUB09426MIG · Substance

Active substance: Olanzapine
Pharmaceutical form: TABLET
Route of administration: APPLICATION
Max daily dose: 999
Max total dose: 999
Max treatment duration: 999 Week(s)
Authorisation status: Authorised
ATC code: - — -
Marketing authorisation: -
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Clozapine

SUB06787MIG · Substance

Active substance: Clozapine
Pharmaceutical form: TABLET
Route of administration: APPLICATION
Max daily dose: 999
Max total dose: 999
Max treatment duration: 999 Week(s)
Authorisation status: Authorised
ATC code: - — -
Marketing authorisation: -
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Sulpiride

SUB10758MIG · Substance

Active substance: Sulpiride
Pharmaceutical form: TABLET
Route of administration: APPLICATION
Max daily dose: 999
Max total dose: 999
Max treatment duration: 999 Week(s)
Authorisation status: Authorised
ATC code: - — -
Marketing authorisation: -
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Lurasidone

SUB32185 · Substance

Active substance: Lurasidone
Pharmaceutical form: FILM-COATED TABLET
Route of administration: APPLICATION
Max daily dose: 999
Max total dose: 999
Max treatment duration: 999 Week(s)
Authorisation status: Authorised
ATC code: - — -
Marketing authorisation: -
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Quetiapine

SUB10192MIG · Substance

Active substance: Quetiapine
Pharmaceutical form: TABLET
Route of administration: APPLICATION
Max daily dose: 999
Max total dose: 999
Max treatment duration: 999 Week(s)
Authorisation status: Authorised
ATC code: - — -
Marketing authorisation: -
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Amisulpride

SUB05458MIG · Substance

Active substance: Amisulpride
Pharmaceutical form: TABLET
Route of administration: APPLICATION
Max daily dose: 999
Max total dose: 999
Max treatment duration: 999 Week(s)
Authorisation status: Authorised
ATC code: - — -
Marketing authorisation: -
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: Yes
Modification description: Updates included adjustments in sections related to safety warnings, such as reporting side effects, precautions for use, and undesirable effects. Specific sections, like warnings about driving, precautions for patients with pre-existing conditions, and side effects related to the central nervous system (e.g., extrapyramidal symptoms), were modified as part of the regulatory updates

Risperidone

SUB10335MIG · Substance

Active substance: Risperidone
Pharmaceutical form: TABLET
Route of administration: APPLICATION
Max daily dose: 999
Max total dose: 999
Max treatment duration: 999 Week(s)
Authorisation status: Authorised
ATC code: - — -
Marketing authorisation: -
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Sertindole

SUB10498MIG · Substance

Active substance: Sertindole
Pharmaceutical form: FILM-COATED TABLET
Route of administration: APPLICATION
Max daily dose: 999
Max total dose: 999
Max treatment duration: 999 Week(s)
Authorisation status: Authorised
ATC code: - — -
Marketing authorisation: -
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Haloperidol

SUB08005MIG · Substance

Active substance: Haloperidol
Pharmaceutical form: TABLET
Route of administration: APPLICATION
Max daily dose: 999
Max total dose: 999
Max treatment duration: 999 Week(s)
Authorisation status: Authorised
ATC code: - — -
Marketing authorisation: -
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Chlorpromazine

SUB06208MIG · Substance

Active substance: Chlorpromazine
Pharmaceutical form: FILM-COATED TABLET
Route of administration: APPLICATION
Max daily dose: 999
Max total dose: 999
Max treatment duration: 999 Week(s)
Authorisation status: Authorised
ATC code: - — -
Marketing authorisation: -
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Tiapride

SUB11010MIG · Substance

Active substance: Tiapride
Pharmaceutical form: TABLET
Route of administration: APPLICATION
Max daily dose: 999
Max total dose: 999
Max treatment duration: 999 Week(s)
Authorisation status: Authorised
ATC code: - — -
Marketing authorisation: -
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Pimozide

SUB09847MIG · Substance

Active substance: Pimozide
Pharmaceutical form: TABLET
Route of administration: APPLICATION
Max daily dose: 999
Max total dose: 999
Max treatment duration: 999 Week(s)
Authorisation status: Authorised
ATC code: - — -
Marketing authorisation: -
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Paliperidone

SUB23268 · Substance

Active substance: Paliperidone
Pharmaceutical form: PROLONGED-RELEASE TABLET
Route of administration: APPLICATION
Max daily dose: 999
Max total dose: 999
Max treatment duration: 999 Week(s)
Authorisation status: Authorised
ATC code: - — -
Marketing authorisation: -
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Universitair Medisch Centrum Groningen

Sponsor organisation: Universitair Medisch Centrum Groningen
Address: Hanzeplein 1
City: Groningen
Postcode: 9713 GZ
Country: Netherlands

Scientific contact point

Organisation: Universitair Medisch Centrum Groningen
Contact name: Iris Sommer

Public contact point

Organisation: Universitair Medisch Centrum Groningen
Contact name: Jort Noorman

Locations

1 EU/EEA country · 2 investigational sites

By country

Country	MS status	Planned subjects	Sites
Netherlands	Ongoing, recruitment ended	444	2
Rest of world	—	0	—

Investigational sites

Netherlands

2 sites · Ongoing, recruitment ended

Universitair Medisch Centrum Groningen

BSCS, Hanzeplein 1, 9713 GZ, Groningen

Universitair Medisch Centrum Utrecht

Psychiatry, Universiteitsweg 99/100, 3584 CG, Utrecht

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Country	Trial start	Trial end	Recruitment start	Recruitment end	Early termination
Netherlands	2024-11-25		2024-11-25	2024-11-25

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 17 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Type	Title	Version
Protocol (for publication)	D1_Protocol 2024-518769-80-00	1.11
Recruitment arrangements (for publication)	Blank document	1
Subject information and informed consent form (for publication)	L1_SIS and ICF	1.11
Summary of Product Characteristics (SmPC) (for publication)	Justification for no IMPD or SmPC	1
Summary of Product Characteristics (SmPC) (for publication)	Justification for no IMPD or SmPC	1
Summary of Product Characteristics (SmPC) (for publication)	Justification for no IMPD or SmPC	1
Summary of Product Characteristics (SmPC) (for publication)	Justification for no IMPD or SmPC	1
Summary of Product Characteristics (SmPC) (for publication)	Justification for no IMPD or SmPC	1
Summary of Product Characteristics (SmPC) (for publication)	Justification for no IMPD or SmPC	1
Summary of Product Characteristics (SmPC) (for publication)	Justification for no IMPD or SmPC	1
Summary of Product Characteristics (SmPC) (for publication)	Justification for no IMPD or SmPC	1
Summary of Product Characteristics (SmPC) (for publication)	Justification for no IMPD or SmPC	1
Summary of Product Characteristics (SmPC) (for publication)	Justification for no IMPD or SmPC	1
Summary of Product Characteristics (SmPC) (for publication)	Justification for no IMPD or SmPC	1
Summary of Product Characteristics (SmPC) (for publication)	Justification for no IMPD or SmPC	1
Summary of Product Characteristics (SmPC) (for publication)	Justification for no IMPD or SmPC	1
Summary of Product Characteristics (SmPC) (for publication)	Justification for no IMPD or SmPC	1

Application history

1 submissions — initial application plus substantial / non-substantial modifications

#	Type	Code	Submitted	Reference MS	Conclusion	Decision date
1	INITIAL	IN	2024-10-15	Netherlands	Acceptable 2024-11-25	2024-11-25