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

Recruiting

Conditions: Psychotic disorder / Schizophrenia
10039628

Registration Number: NL-OMON52454

Lead Sponsor: niversitair Medisch Centrum Groningen

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 225

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 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

Study & Design

Study Type: Observational non invasive

Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

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