Neuroprotective Effects of Risperdal on Brain and Cognition in 22q11 Deletion Syndrome
- Conditions
- Interventions
- Registration Number
- NCT04639960
- Lead Sponsor
- University of Geneva, Switzerland
- Brief 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 recepto...
- Detailed Description
In a double-blind placebo design, this study investigates the effects of a 12 weeks treatment of risperidone (vs placebo) for participants with 22q11DS without psychotic symptoms.
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Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 16
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Placebo - Risperidone Risperdal -
- Primary Outcome Measures
Name Time Method Letter-number sequencing Letter-number Sequencing six month after treatment A working memory subtest of the Wechsler Adult Intelligence Scale (WAIS) and the Wechsler Intelligence Scale for Children (WISC) in which the participant must sequence a random order of numbers and letters. Specifically, the participant must first say the numbers in ascending order and then the letters in alphabetical order. Longest sequence of letters and n...
Conners' Continuous performance test, third edition (CPT-3) CPT-3 six month after treatment Participants are instructed to press a button every time a letter appeared on the screen, except for the letter X where participants had to withhold their answer. Variables of interest are Detectability, Omission, Commission, Perseveration, Hit Reaction Time, Hit Reaction time Standard Deviation, Variability, Hit Reaction Time Block Change and Hit Reaction T...
Stroop Task Stroop inhibition ratio six month after treatment To measure the cost of cognitive inhibition in time, an inhibition ratio score is computed by dividing the raw score from the Stroop condition (participants have to name the color of the ink even though the word spells a different color) by the raw score in the color naming condition (participants are instructed to name rectangles of colors as fast as possib...
Color Trails test (CTT) CTT flexibility ratio six month after treatment To measure the cost of task switching, a flexibility ratio was calculated to account for processing speed by dividing the time to complete part B (drawing a line between number following chronological order while alternating between colors) by time to complete part A (drawing a line between number following chronological order). Value closer to 1 indicate be...
MRI Spectroscopy MRI Spectroscopy six month after treatment Acquisition of Single-voxel MRI Spectroscopy investigates changes in excitatory/inhibitory balance throughout development. More in detail, a Works-In-Progress (WIP) SVS (Single Voxel Spectroscopy) spin-echo sequence is used provided by Siemens and designed for detecting the GABA (Gamma-AminoButyric Acid) 1H MRS signal at 3 ppm in brain. 3 ROIs are selected: ...
MRI Diffusion weighted images MRI DSI six month after treatment Diffusion weighted images (DWI) are acquired to examine the longitudinal changes in white matter integrity and to quantify changes in tracts connecting a priori defined regions of interest. The patient would be warned about a slightly louder sequence sound and will be asked to watch their preferred video or closes their eyes and relax during this last sequen...
Electroencephalography (EEG) resting state EEG resting state six month after treatment All the EEG data are continuously recorded with a sampling rate of 1000 Hz using a 256-electrode Hydrocel cap referenced to the vertex (Cz). Resting-state data with closed eyes is acquired for 6 minutes.
Cambridge Neuropsychological Test Automated Battery (CANTAB) CANTAB six month after treatment The Motor Screening test (MOT) is a training procedure designed screen for difficulties with vision, movement, or comprehension and ascertains that the subject can follow simple instructions, as well as familiarising them with the touch screen.
...15 signs & 15 words 15 signs & 15 words six month after treatment 15 signs \& 15 words is a homemade episodic memory task inspired by the Rey Auditory Verbal Learning Test (Rey, 1958). Participants are required to learn 15 common French words and 15 signs (drawings made out of 1 or 2 basic geometrical forms). After delays of thirty minutes, one day, one week and one month, participants are asked to freely recall the words ...
Magnetic Resonance Imaging (MRI) T1-weighted MRI T1-weighted six month after treatment T1 structural images are collected to obtain accurate measurements of regional developmental changes in cortical morphometry comprising estimates of cortical volume, thickness and surface area. An MPRAGE T1-weighted sequence is employed with the following parameters: TR = 2500 ms, TE = 3 ms, flip angle = 8°, matrix acquisition = 256 × 256, field of view = 23...
EEG visual EEG Visual six month after treatment Visual inward moving grating task paradigm: participants are presented with 3 blocks of 80 trials, with each trial consisting of a circular sinewave grating that contracted toward central fixation. The task of the participants is to detect and respond by button press to a velocity increase of the stimulus, randomly occurring between 750 and 3000 ms. Feedback...
MRI Resting State MRI resting state six month after treatment Functional MRI sequence without stimulation (resting-state fMRI) scans are employed to assess the longitudinal changes in regional activity and functional connectivity measured by BOLD signal fluctuations. During this sequence, the participants are asked to fix a white cross on a black background for 8 minutes and leave their thoughts wander. Simultaneous re...
EEG auditory EEG Auditory six month after treatment Auditory steady state response paradigm: sequences of 2 types of auditory stimuli are presented binaurally: a 100 ripple tones (40 Hz) and 10 semi-randomly intermixed flat tones (1000 Hz). Ripple tones are presented at about 93 dB and the flat tones at about 83 dB. Participants are asked to detect the flat tone, while the ripple tones entrained the neural ga...
- Secondary Outcome Measures
Name Time Method Behavior Rating Inventory of Executive Function (BRIEF) questionnaire BRIEF six month after treatment Children and Adults version. This questionnaire provides an ecological assessment of EF, with a Global Executive Composite (GEC) score derived from the Behavioral Regulation Index (BRI) and Metacognitive Index (MI). The BRI includes subscales of Inhibition, Shifting, Emotional regulation and only in the adult-form, Self- monitoring. The MI includes subscales...
Trial Locations
- Locations (1)
Developmental imaging and psychopathology lab
🇨🇭Geneva, Switzerland