The effects of antipsychotic maintenance therapy on brain volume: randomized (dis)continuation after remission of a first psychotic episode.

The effects of antipsychotic maintenance therapy on brain volume: randomized (dis)continuation after remission of a first psychotic episode. - HAMLETT MRI

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON52454

Enrollment

225

Registered

2018-08-31

Start date

2019-02-22

Completion date

Unknown

Last updated

2024-10-07

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

Conditions

Psychotic disorder / Schizophrenia

Interventions

None listed

Eligibility

Age

18 Years to 64 Years

Inclusion criteria

Inclusion criteria: Inclusion criteria for FEP patients: 1. The participant has had a first episode of psychosis and uses antipsychotic medication. 2. Psychotic symptoms are in remission for 3-6 months with an antipsychotic. 3. Age 18-60 years. 4. The participant understands the study and is able to provide written informed consent. 5. HAMLETT is the only medical-scientific medication study in which the patient participates. 6. Sufficient command of the Dutch language. Inclusion criteria for healthy controls for OCT: 1. Age 18-60 years. 2. The participant understands the study and is able to provide written informed consent.

Exclusion criteria

Exclusion criteria: Exclusion criteria for FEP patients: 1. Dangerous or harmful behaviour occurred during the psychosis 2. Coercive treatment (based on judicial ruling) 3. The refusal to be informed of structural brain abnormalities that could be detected during the experiment 4. MRI contra-indications, e.g. Ferrous objects in or around the body, or claustrophobia 5. Pregnancy Exclusion criteria for healthy controls for the OCT-scan: 1. (History of) diagnosed psychiatric disorders 2. (History of) psychotropic medication use 3. (History of) neurological diseases that may affect the brain 4. (History of) substance abuse 5. (History of) ophthalmological disorders, as determined with the questionnaire on eye health ('Vragenlijst ooggezondheid*) 6. (History of) systemic and autoimmune diseases that may affect the eye or optic nerve, e.g. diabetes, glaucoma or refractory arterial hypertension 7. First-degree family member with glaucoma

Design outcomes

Primary

Measure	Time frame
The main study parameter concerns brain volume measured with anatomical magnetic resonance imaging (MRI), at two time points: at baseline and at 12 months follow-up. MRI scans will be acquired on a standard 3 Tesla Siemens clinical scanner located at the Radiology Department of the University Medical Center Groningen.	—

Secondary

Measure	Time frame
A secundary study parameter is retinal nerve fiber layer (RNFL) thickness, as measured by optical coherence tomography (OCT). The measurement takes 10 minutes and is non-invasive. Results will be correlated to whole brain volume and total grey volume assessed with MRI. The RNFL of FEP patients will be compared with the RNFL of healthy controls. Other secundary study parameters are assessed during and as part of the HAMLETT core study and include: Physical health, movement disorders, language, symptom severity, cognition, global functioning, social functioning, medication use and adverse events.	—

Measure

Time frame

A secundary study parameter is retinal nerve fiber layer (RNFL) thickness, as measured by optical coherence tomography (OCT). The measurement takes 10 minutes and is non-invasive. Results will be correlated to whole brain volume and total grey volume assessed with MRI. The RNFL of FEP patients will be compared with the RNFL of healthy controls. Other secundary study parameters are assessed during and as part of the HAMLETT core study and include: Physical health, movement disorders, language, symptom severity, cognition, global functioning, social functioning, medication use and adverse events.

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Countries

Netherlands

Outcome results