Riluzole as treatment for psychotic and cognitive symptoms in 22q11.2 deletion syndrome

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

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2021-002011-61-NL

Enrollment

Registered

2021-06-21

Start date

2021-08-13

Completion date

Unknown

Last updated

2025-03-24

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

Conditions

22q11.2 deletion syndrome

Interventions

Trade Name: Rilutek Product Name: Riluzole Product Code: EMEA/H/C/000109 Pharmaceutical Form: Capsule Pharmaceutical form of the placebo: Capsule Route of administration of the placebo: Oral use

Eligibility

Sex/Gender

All

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 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)). Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 46 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: - Other chromosomal abnormalities. - Current substance abuse / dependence. - Use of first-generation antipsychotics or clozapine. Use of second-generation antipsychotics is allowed. - Contraindications for MRI. - Contraindications for riluzole. - Pregnancy.

Design outcomes

Primary

Measure	Time frame
Main Objective: The objective of this study is to examine the efficacy of riluzole, a modulator of the glutamate /GABA balance, for treatment of psychotic symptoms and cognitive impairment in 22q11.2DS patients. ;Secondary Objective: The secondary objective is to examine effects of riluzole on the glutamate/GABA-balance in order to increase insight in the neurobiological underpinnings of these symptoms. ;Primary end point(s): The main endpoint will be the change in psychotic and cognitive symptom severity. ;Timepoint(s) of evaluation of this end point: At the end of each intervention period	—

Measure

Time frame

Main Objective: The objective of this study is to examine the efficacy of riluzole, a modulator of the glutamate /GABA balance, for treatment of psychotic symptoms and cognitive impairment in 22q11.2DS patients. ;Secondary Objective: The secondary objective is to examine effects of riluzole on the glutamate/GABA-balance in order to increase insight in the neurobiological underpinnings of these symptoms. ;Primary end point(s): The main endpoint will be the change in psychotic and cognitive symptom severity. ;Timepoint(s) of evaluation of this end point: At the end of each intervention period

—

Secondary

Measure	Time frame
Secondary end point(s): The secondary study endpoint will be the change in glutamate and GABA concentrations in the anterior cingulate cortex. ;Timepoint(s) of evaluation of this end point: At the end of each intervention period	—

Countries

Netherlands

Contacts

Public ContactTherese van Amelsvoort

Academisch ziekenhuis Maastricht

t.vanamelsvoort@maastrichtuniversity.nl

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026