Neuroprotective Effects of Risperdal on Brain and Cognition in 22q11 Deletion Syndrome
NCT ID: NCT04639960
Last Updated: 2024-12-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
NA
16 participants
INTERVENTIONAL
2017-09-29
2021-05-01
Brief Summary
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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.
Detailed Description
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The research hypothesis of this study is that a short-term (12 weeks) risperidone (Risperdal®) treatment during a critical phase of development (adolescence) will result in improved cognitive performance and brain changes observable using brain imaging techniques (Magnetic resonance Imaging, MRI and Electroencephalography, EEG). In addition, the beneficial effects will be observable in a follow-up evaluation, 6 months after the of treatment.
Risperdal® is a marketed product and is listed in the Swiss Compendium (2015). However, it is not used according to its indication for the treatment of psychotic disorders. The treatment will be administered orally in the form of capsules containing the ground tablet in order to preserve the double-blind procedure (meaning that neither the examiner nor the patient knows whether the capsule contains the active ingredient risperidone or a placebo). The dose will be individually adjusted according to the weight of each participant. The lowest dose recommended in the Swiss Compendium is 0.25 mg/day for children. Therefore this dos will be prescribe at the beginning of the treatment and then gradually increased to 0.25 mg gradually over 7 days. For individuals weighing less than 50 kg, the recommended dose is 0.5 mg/day, this dose will not be exceeded for these individuals. For individuals over 50 kg, the recommended dose is 1 mg/day. this dose will not exceeded for individuals over 50 kg. However, in order to adapt as closely as possible to the different weight categories, a dose of 0.75 mg will be given to the 51 to 70 kg weight category, and a maximum dose of 1 mg to individuals over 70 kg. Treatment will also be discontinued in progressive stages over a period of two weeks.
Each participant will complete a series of evaluations including cognitive tests and brain imaging (MRI and EEG) on 3 occasions: the 1st before the treatment period (baseline), the 2nd at the end of the treatment period (short-term effect) and the 3rd 6 months after the end of treatment (long-term effect).
Conditions
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Study Design
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RANDOMIZED
PARALLEL
OTHER
QUADRUPLE
Study Groups
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Risperidone
Risperdal
Twelve weeks of treatment with a gradual increase of dosage over one week and a gradual decrease over two weeks.
Placebo
Placebo
Twelve weeks of placebo treatment.
Interventions
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Risperdal
Twelve weeks of treatment with a gradual increase of dosage over one week and a gradual decrease over two weeks.
Placebo
Twelve weeks of placebo treatment.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Minimum age of 8 years or maximum age of 25 years and 11 months.
* Sufficient verbal expression and comprehension skills to understand and follow instructions based on initial interview.
Exclusion Criteria
* Previous adverse experience with risperidone
* Psychotic symptoms requiring sustained antipsychotic treatment
* Corrected QT (QTc) distance at baseline electrocardiogram above 460 milliseconds or elongation at control electrocardiogram (Day 6 of treatment) superior to 30 milliseconds with functional complaint.
* Pregnancy or breastfeeding.
11 Years
25 Years
ALL
No
Sponsors
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University of Geneva, Switzerland
OTHER
Responsible Party
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Stephan Eliez
Principal Investigator
Principal Investigators
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Stephan Eliez, Professor
Role: PRINCIPAL_INVESTIGATOR
University of Geneva, faculty of medicine
Locations
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Developmental imaging and psychopathology lab
Geneva, , Switzerland
Countries
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References
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Latreche C, Maeder J, Mancini V, Schneider M, Eliez S. Effects of risperidone on psychotic symptoms and cognitive functions in 22q11.2 deletion syndrome: Results from a clinical trial. Front Psychiatry. 2022 Oct 26;13:972420. doi: 10.3389/fpsyt.2022.972420. eCollection 2022.
Other Identifiers
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PB_201601540
Identifier Type: -
Identifier Source: org_study_id