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

Phase 1

• Conditions: 22q11.2 deletion syndrome; Therapeutic area: Psychiatry and Psychology [F] - Mental Disorders [F03]

• Registration Number: EUCTR2021-002011-61-NL
• Lead Sponsor: Academisch ziekenhuis Maastricht

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-06-21
• Last Update Posted: 17 August 2021

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 45

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.
•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 45
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

- Other chromosomal abnormalities.
- Current substance abuse / dependence.
- Use of first-generation antipsychotics or clozapine.
- Contraindications for MRI.
- Contraindications for riluzole.
- Pregnancy.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified