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Register:	ClinicalTrials.gov
Last refreshed on:	6 January 2025
Main ID:	NCT04639960
Date of registration:	03/11/2020
Prospective Registration:	No
Primary sponsor:	University of Geneva, Switzerland
Public title:	Neuroprotective Effects of Risperdal on Brain and Cognition in 22q11 Deletion Syndrome
Scientific title:	Effects of Modulation of the Dopaminergic System Using Risperidone on Memory and Executive Processes in Individuals With 22q11.2 Deletion Syndrome
Date of first enrolment:	September 29, 2017
Target sample size:	16
Recruitment status:	Terminated
URL:	https://clinicaltrials.gov/ct2/show/NCT04639960
Study type:	Interventional
Study design:	Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Other. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
Phase:	N/A

Countries of recruitment
Switzerland

Contacts

Name:	Stephan Eliez, Professor
Address:
Telephone:
Email:
Affiliation:	University of Geneva, faculty of medicine

Key inclusion & exclusion criteria

Inclusion Criteria:

- Male or female with confirmed 22q11DS diagnosis.

- 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:

- Participants younger than 8 years and older that 25 years and 11 months.

- 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.

Age minimum: 11 Years
Age maximum: 25 Years
Gender: All

Health Condition(s) or Problem(s) studied

22q11.2 Deletion Syndrome

Intervention(s)

Drug: Placebo

Drug: Risperdal

Primary Outcome(s)

15 signs & 15 words [Time Frame: 15 signs & 15 words six month after treatment]

Electroencephalography (EEG) resting state [Time Frame: EEG resting state one week after treatment]

Electroencephalography (EEG) resting state [Time Frame: EEG resting state six month after treatment]

MRI Diffusion weighted images [Time Frame: MRI DSI six month after treatment]

MRI Resting State [Time Frame: MRI resting state one week after treatment]

Cambridge Neuropsychological Test Automated Battery (CANTAB) [Time Frame: CANTAB six month after treatment]

Cambridge Neuropsychological Test Automated Battery (CANTAB) [Time Frame: CANTAB one week after treatment]

EEG auditory [Time Frame: EEG Auditory pre-treatment]

Letter-number sequencing [Time Frame: Letter-number Sequencing one week after treatment]

Color Trails test (CTT) [Time Frame: CTT flexibility ratio pre-treatment]

Conners' Continuous performance test, third edition (CPT-3) [Time Frame: CPT-3 six month after treatment]

Letter-number sequencing [Time Frame: Letter-number Sequencing six month after treatment]

Magnetic Resonance Imaging (MRI) T1-weighted [Time Frame: MRI T1-weighted one week after treatment]

EEG visual [Time Frame: EEG Visual one week after treatment]

EEG visual [Time Frame: EEG Visual six month after treatment]

Magnetic Resonance Imaging (MRI) T1-weighted [Time Frame: MRI T1-weighted six month after treatment]

Stroop Task [Time Frame: Stroop inhibition ratio pre-treatment]

Conners' Continuous performance test, third edition (CPT-3) [Time Frame: CPT-3 One week after treatment]

EEG auditory [Time Frame: EEG Auditory six month after treatment]

EEG visual [Time Frame: EEG Visual pre-treatment]

15 signs & 15 words [Time Frame: 15 signs & 15 words on week after treatment]

EEG auditory [Time Frame: EEG Auditory one week after treatment]

15 signs & 15 words [Time Frame: 15 signs & 15 words pre-treatment]

Cambridge Neuropsychological Test Automated Battery (CANTAB) [Time Frame: CANTAB pre-treatment]

Color Trails test (CTT) [Time Frame: CTT flexibility ratio six month after treatment]

Conners' Continuous performance test, third edition (CPT-3) [Time Frame: CPT-3 pre-treatment]

Letter-number sequencing [Time Frame: Letter-number Sequencing pre-treatment]

Stroop Task [Time Frame: Stroop inhibition ratio six month after treatment]

Electroencephalography (EEG) resting state [Time Frame: EEG resting state pre-treatment]

MRI Diffusion weighted images [Time Frame: MRI DSI one week after treatment]

MRI Diffusion weighted images [Time Frame: MRI DSI pre-treatment]

MRI Resting State [Time Frame: MRI resting state pre-treatment]

MRI Resting State [Time Frame: MRI resting state six month after treatment]

MRI Spectroscopy [Time Frame: MRI Spectroscopy one week after treatment]

MRI Spectroscopy [Time Frame: MRI Spectroscopy six month after treatment]

Magnetic Resonance Imaging (MRI) T1-weighted [Time Frame: MRI T1-weighted pre-treatment]

Stroop Task [Time Frame: Stroop inhibition ratio one week after treatment]

Color Trails test (CTT) [Time Frame: CTT flexibility ratio one week after treatment]

MRI Spectroscopy [Time Frame: MRI Spectroscopy pre-treatment]

Secondary Outcome(s)

Behavior Rating Inventory of Executive Function (BRIEF) questionnaire [Time Frame: BRIEF pre-treatment]

Behavior Rating Inventory of Executive Function (BRIEF) questionnaire [Time Frame: BRIEF one week after treatment]

Behavior Rating Inventory of Executive Function (BRIEF) questionnaire [Time Frame: BRIEF six month after treatment]

Secondary ID(s)

PB_201601540

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Ethics review

Results

Results available:
Date Posted:
Date Completed:
URL:

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