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Neuroprotective Effects of Risperdal on Brain and Cognition in 22q11 Deletion Syndrome

NCT04639960 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 16

Last updated 2024-12-06

No results posted yet for this study

Summary

Chromosome 22q11.2 deletion syndrome (22q11DS) is a neurogenetic condition associated with a high risk of psychiatric disorders, including schizophrenia spectrum disorders. This population is characterized by a particular neurocognitive profile and atypical brain development. Risperidone is a second-generation antipsychotic, inhibitor of dopaminergic receptors. Used in the treatment of psychosis, risperidone is frequently prescribed in 22q11DS, for example to treat a psychotic episode. Research on an animal model of 22q11DS (LgDel+/- mice) shows that administering an antipsychotic for 12 days during a critical period of brain development (adolescence) prevents deleterious neuronal changes and improves behavioral performance in mice. The aim of this study is therefore to replicate the results found in mice and to identify a long-term neuroprotective effect.

This study is inspired on the one hand by the families who share with us the difficulties of individuals affected by 22q11DS on a daily basis, but also by the encouraging results of studies conducted on mice.

Conditions

  • 22q11.2 Deletion Syndrome

Interventions

DRUG

Risperdal

Twelve weeks of treatment with a gradual increase of dosage over one week and a gradual decrease over two weeks.

DRUG

Placebo

Twelve weeks of placebo treatment.

Sponsors & Collaborators

  • University of Geneva, Switzerland

    lead OTHER

Principal Investigators

  • Stephan Eliez, Professor · University of Geneva, faculty of medicine

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
11 Years
Max Age
25 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-09-29
Primary Completion
2021-05-01
Completion
2021-05-01

Countries

  • Switzerland

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04639960 on ClinicalTrials.gov