Velocardiofacial syndrome (VCFS)
Conditions
Interventions
All subjects will undergo two 8-week intervention periods, once with placebo
and once with 100 mg. riluzole daily (50 mg. twice daily).
Sponsors
Medisch Universitair Ziekenhuis Maastricht
Eligibility
Age
16 Years to 64 Years
Inclusion criteria
Inclusion criteria: • 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. • 16 years, incompetent to provide written informed consent. In these cases consent will be obtained from the legal representative of the subject. • Presence of psychotic and/or cognitive symptoms (defined as a score of >=4, moderately ill, on the Clinical Global Impression-Schizophrenia Scale (CGI-SCH)).
Exclusion criteria
Exclusion criteria: • Other chromosomal abnormalities. • Current substance abuse / dependence. • Use of psychotropic medication and / or first-generation antipsychotics or clozapine, with the exception of second-generation antipsychotics. • Contraindications for MRI. • Pre-existing liver function disorders and / or ALAT/ASAT > 3x ULN. • Contraindications for riluzole. • Pregnancy, or trying to get pregnant and breastfeeding. • In case of mentally incompetent patients, resistance to participation will be an additional exclusion criterion.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary study endpoint will be the change in glutamate and GABA concentrations in the anterior cingulate cortex. | — |
Secondary
| Measure | Time frame |
|---|---|
| The secondary endpoint will be the change in psychotic and cognitive symptom severity. | — |
Countries
Netherlands
Outcome results
None listed