Riluzole in 22q11DS
- Conditions
- 22q11.2 deletion syndrome / psychotic disorder
- Registration Number
- NL-OMON28681
- Lead Sponsor
- MUMC
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 45
•Confirmed diagnosis of 22q11.2 deletion syndrome established by FISH, microarray or MLPA analysis.
•16 year or older of age and mentally competent (determined by an experienced physician) to decide about participation and give informed consent.
•Presence of psychotic and/or cognitive symptoms (defined as a score of =4, moderately ill, on the Clinical Global Impression-Schizophrenia Scale (CGI-SCH)).
•Other chromosomal abnormalities.
•Current substance abuse / dependence.
•Use of psychotropic medication and / or first-generation antipsychotics or clozapine.
•Contraindications for MRI.
•Contraindications for riluzole.
•Pre-existing liver function disorders and / or ALAT/ASAT > 3x ULN.
•Pregnancy or trying to get pregnant and breastfeeding.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The main endpoint will be the change in psychotic and cognitive symptom severity.
- Secondary Outcome Measures
Name Time Method The secondary study endpoint will be the change in glutamate and GABA concentrations in the anterior cingulate cortex (ACC)