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

NCT04639960 | Terminated

• 1 other identifier: PB_201601540
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

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 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

Outcome Measures

Primary Outcomes (39)

• Conners' Continuous performance test, third edition (CPT-3)

  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 Time Inter- Stimulus Intervals Change.

  CPT-3 pre-treatment

• Conners' Continuous performance test, third edition (CPT-3)

  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 Time Inter- Stimulus Intervals Change.

  CPT-3 One week after treatment

• Conners' Continuous performance test, third edition (CPT-3)

  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 Time Inter- Stimulus Intervals Change.

  CPT-3 six month after treatment

• Stroop Task

  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 possible). This score reflects the cognitive cost of inhibiting the reading process. A ratio value close to 1 indicates a lesser cost of inhibition.

  Stroop inhibition ratio pre-treatment

• Stroop Task

  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 possible). This score reflects the cognitive cost of inhibiting the reading process. A ratio value close to 1 indicates a lesser cost of inhibition.

  Stroop inhibition ratio one week after treatment

• Stroop Task

  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 possible). This score reflects the cognitive cost of inhibiting the reading process. A ratio value close to 1 indicates a lesser cost of inhibition.

  Stroop inhibition ratio six month after treatment

• Letter-number sequencing

  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 numbers correctly ordered

  Letter-number Sequencing pre-treatment

• Letter-number sequencing

  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 numbers correctly ordered

  Letter-number Sequencing one week after treatment

• Letter-number sequencing

  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 numbers correctly ordered

  Letter-number Sequencing six month after treatment

• Color Trails test (CTT)

  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 better flexibility.

  CTT flexibility ratio pre-treatment

• Color Trails test (CTT)

  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 better flexibility.

  CTT flexibility ratio one week after treatment

• Color Trails test (CTT)

  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 better flexibility.

  CTT flexibility ratio six month after treatment

• Cambridge Neuropsychological Test Automated Battery (CANTAB)

  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. Intra-Extra Dimensional Set Shift (IED) is a test of rule acquisition and reversal. It features visual discrimination and attentional set formation maintenance, shifting and flexibility of attention. Spatial Working Memory (SWM) is a test of the subject's ability to retain spatial information and to manipulate remembered items in working memory. It is a self-ordered task, which also assesses heuristic strategy. Stop Signal Task (SST) is a classic stop signal response inhibition test, which uses staircase functions to generate an estimate of stop signal reaction time. This test gives a measure of an individual's ability to inhibit a prepotent response.

  CANTAB pre-treatment

• Cambridge Neuropsychological Test Automated Battery (CANTAB)

  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. Intra-Extra Dimensional Set Shift (IED) is a test of rule acquisition and reversal. It features visual discrimination and attentional set formation maintenance, shifting and flexibility of attention. Spatial Working Memory (SWM) is a test of the subject's ability to retain spatial information and to manipulate remembered items in working memory. It is a self-ordered task, which also assesses heuristic strategy. Stop Signal Task (SST) is a classic stop signal response inhibition test, which uses staircase functions to generate an estimate of stop signal reaction time. This test gives a measure of an individual's ability to inhibit a prepotent response.

  CANTAB one week after treatment

• Cambridge Neuropsychological Test Automated Battery (CANTAB)

  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. Intra-Extra Dimensional Set Shift (IED) is a test of rule acquisition and reversal. It features visual discrimination and attentional set formation maintenance, shifting and flexibility of attention. Spatial Working Memory (SWM) is a test of the subject's ability to retain spatial information and to manipulate remembered items in working memory. It is a self-ordered task, which also assesses heuristic strategy. Stop Signal Task (SST) is a classic stop signal response inhibition test, which uses staircase functions to generate an estimate of stop signal reaction time. This test gives a measure of an individual's ability to inhibit a prepotent response.

  CANTAB six month after treatment

• 15 signs & 15 words

  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 and the signs they remembered. They are also asked to recognize the target items form a list of distractors. Variables of interest are (1) learning score = Maximum number of items correctly recalled during learning divided by the number of trials to reach learning criterion. Low score indicates poor learning. (2) Retention % thirty minutes/on day/one week/one month = Number of items recalled after each delay in time divided by the maximum of items recalled during learning. Low score indicates poor memory.

  15 signs & 15 words pre-treatment

• 15 signs & 15 words

  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 and the signs they remembered. They are also asked to recognize the target items form a list of distractors. Variables of interest are (1) learning score = Maximum number of items correctly recalled during learning divided by the number of trials to reach learning criterion. Low score indicates poor learning. (2) Retention % thirty minutes/on day/one week/one month = Number of items recalled after each delay in time divided by the maximum of items recalled during learning. Low score indicates poor memory.

  15 signs & 15 words on week after treatment

• 15 signs & 15 words

  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 and the signs they remembered. They are also asked to recognize the target items form a list of distractors. Variables of interest are (1) learning score = Maximum number of items correctly recalled during learning divided by the number of trials to reach learning criterion. Low score indicates poor learning. (2) Retention % thirty minutes/on day/one week/one month = Number of items recalled after each delay in time divided by the maximum of items recalled during learning. Low score indicates poor memory.

  15 signs & 15 words six month after treatment

• Magnetic Resonance Imaging (MRI) T1-weighted

  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 = 23.5 cm, slice thickness = 3.2 mm, 192 slices.

  MRI T1-weighted pre-treatment

• Magnetic Resonance Imaging (MRI) T1-weighted

  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 = 23.5 cm, slice thickness = 3.2 mm, 192 slices.

  MRI T1-weighted one week after treatment

• Magnetic Resonance Imaging (MRI) T1-weighted

  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 = 23.5 cm, slice thickness = 3.2 mm, 192 slices.

  MRI T1-weighted six month after treatment

• MRI Spectroscopy

  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: Anterior cingulate cortex (voxel size: 15 x 35 x 40, 98 avg), right hippocampus (voxel size: 20 x 30 x 40, 150 avg) and temporal cortex (voxel size: 30 x 30 x 30, 120 avg) that are manually placed during each session. Each sequence lasts around 7 minutes and patients are allowed to watch a video of their choice during the acquisition.

  MRI Spectroscopy pre-treatment

• MRI Spectroscopy

  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: Anterior cingulate cortex (voxel size: 15 x 35 x 40, 98 avg), right hippocampus (voxel size: 20 x 30 x 40, 150 avg) and temporal cortex (voxel size: 30 x 30 x 30, 120 avg) that are manually placed during each session. Each sequence lasts around 7 minutes and patients are allowed to watch a video of their choice during the acquisition.

  MRI Spectroscopy one week after treatment

• MRI Spectroscopy

  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: Anterior cingulate cortex (voxel size: 15 x 35 x 40, 98 avg), right hippocampus (voxel size: 20 x 30 x 40, 150 avg) and temporal cortex (voxel size: 30 x 30 x 30, 120 avg) that are manually placed during each session. Each sequence lasts around 7 minutes and patients are allowed to watch a video of their choice during the acquisition.

  MRI Spectroscopy six month after treatment

• MRI Resting State

  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 recording of physiological parameters (heart rate and respiration) are employed to account for possible artifacts. (Parameters: 200 blood-oxygenation-level-dependent (BOLD) images with TR = 2400 ms, TE = 30 ms, 38 axial slices, slice thickness = 3.2 mm, flip angle = 85°, acquisition matrix = 94 × 128, field of view = 96 × 128).

  MRI resting state pre-treatment

• MRI Resting State

  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 recording of physiological parameters (heart rate and respiration) are employed to account for possible artifacts. (Parameters: 200 blood-oxygenation-level-dependent (BOLD) images with TR = 2400 ms, TE = 30 ms, 38 axial slices, slice thickness = 3.2 mm, flip angle = 85°, acquisition matrix = 94 × 128, field of view = 96 × 128).

  MRI resting state one week after treatment

• MRI Resting State

  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 recording of physiological parameters (heart rate and respiration) are employed to account for possible artifacts. (Parameters: 200 blood-oxygenation-level-dependent (BOLD) images with TR = 2400 ms, TE = 30 ms, 38 axial slices, slice thickness = 3.2 mm, flip angle = 85°, acquisition matrix = 94 × 128, field of view = 96 × 128).

  MRI resting state six month after treatment

• MRI Diffusion weighted images

  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 sequence. DSI parameters are number of directions = 137, b = 3000 s/mm2, TR = 5100 ms, TE = 80 ms, Voxel size= 1.6x1.6x1.6, field of view = 23.9 cm, 64 axial slices, slice thickness = 1.6 mm.

  MRI DSI pre-treatment

• MRI Diffusion weighted images

  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 sequence. DSI parameters are number of directions = 137, b = 3000 s/mm2, TR = 5100 ms, TE = 80 ms, Voxel size= 1.6x1.6x1.6, field of view = 23.9 cm, 64 axial slices, slice thickness = 1.6 mm.

  MRI DSI one week after treatment

• MRI Diffusion weighted images

  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 sequence. DSI parameters are number of directions = 137, b = 3000 s/mm2, TR = 5100 ms, TE = 80 ms, Voxel size= 1.6x1.6x1.6, field of view = 23.9 cm, 64 axial slices, slice thickness = 1.6 mm.

  MRI DSI six month after treatment

• Electroencephalography (EEG) resting state

  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.

  EEG resting state pre-treatment

• Electroencephalography (EEG) resting state

  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.

  EEG resting state one week after treatment

• Electroencephalography (EEG) resting state

  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.

  EEG resting state six month after treatment

• EEG auditory

  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 gamma oscillatory response. The duration of the task is around 7 minutes.

  EEG Auditory pre-treatment

• EEG auditory

  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 gamma oscillatory response. The duration of the task is around 7 minutes.

  EEG Auditory one week after treatment

• EEG auditory

  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 gamma oscillatory response. The duration of the task is around 7 minutes.

  EEG Auditory six month after treatment

• EEG visual

  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 on performance is provided on every trial, shortly after the response onset terminated stimulus presentation. The duration of the task is around 21 minutes in 3 blocks.

  EEG Visual pre-treatment

• EEG visual

  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 on performance is provided on every trial, shortly after the response onset terminated stimulus presentation. The duration of the task is around 21 minutes in 3 blocks.

  EEG Visual one week after treatment

• EEG visual

  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 on performance is provided on every trial, shortly after the response onset terminated stimulus presentation. The duration of the task is around 21 minutes in 3 blocks.

  EEG Visual six month after treatment

Secondary Outcomes (3)

• Behavior Rating Inventory of Executive Function (BRIEF) questionnaire

  BRIEF pre-treatment

• Behavior Rating Inventory of Executive Function (BRIEF) questionnaire

  BRIEF one week after treatment

• Behavior Rating Inventory of Executive Function (BRIEF) questionnaire

  BRIEF six month after treatment

Other Outcomes (6)

• Sensory-motor conflict 1

  Synchrony condition pre-treatment

• Sensory-motor conflict 1

  Synchrony condition one week after treatment

• Sensory-motor conflict 1

  Synchrony condition six month after treatment

Study Arms (2)

Risperidone

EXPERIMENTAL

Drug: Risperdal

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

Risperdal DRUG

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

Also known as: risperidone

Risperidone

Placebo DRUG

Twelve weeks of placebo treatment.

Placebo

Eligibility Criteria

• Age: 11 Years - 25 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Geneva, Switzerland: lead

Study Sites (1)

Developmental imaging and psychopathology lab

Geneva, 1204, Switzerland

Location

Related Publications (1)

• 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.

  PMID: 36386982 DERIVED

MeSH Terms

Conditions

DiGeorge Syndrome

Interventions

Risperidone

Condition Hierarchy (Ancestors)

22q11 Deletion Syndrome; Craniofacial Abnormalities; Musculoskeletal Abnormalities; Musculoskeletal Diseases; Heart Defects, Congenital; Cardiovascular Abnormalities; Cardiovascular Diseases; Heart Diseases; Lymphatic Abnormalities; Lymphatic Diseases; Hemic and Lymphatic Diseases; Abnormalities, Multiple; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Chromosome Disorders; Genetic Diseases, Inborn; Hypoparathyroidism; Parathyroid Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Pyrimidinones; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Stephan Eliez, Professor

  University of Geneva, faculty of medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: the pharmacy has prepared the randomization. group membership will be revealed at the end of the study.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: double blind placebo design

Study Record Dates

• First Submitted: November 3, 2020
• First Posted: November 23, 2020
• Study Start: September 29, 2017
• Primary Completion: May 1, 2021
• Study Completion: May 1, 2021
• Last Updated: December 6, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)