MedPath

The glutamate/GABA balance as novel therapeutic target for psychotic and cognitive symptoms in 22q11.2 deletion syndrome

Phase 4
Recruiting
Conditions
Velocardiofacial syndrome (VCFS)
DiGeorge syndrome
10083624
10042258
10039628
Registration Number
NL-OMON52172
Lead Sponsor
Medisch Universitair Ziekenhuis Maastricht
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Recruiting
Sex
Not specified
Target Recruitment
46
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

• 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.

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
<p>The primary study endpoint will be the change in glutamate and GABA<br /><br>concentrations in the anterior cingulate cortex.</p><br>
Secondary Outcome Measures
NameTimeMethod
<p>The secondary endpoint will be the change in psychotic and cognitive symptom<br /><br>severity. </p><br>
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