22q11.2 Deletion SyndromePremiCeS22NCT04639388
Understanding of Psychotic Disorders in Children With 22q11.2DS
A study testing neuropsychological testing, questionnaires and experimental tasks in people with 22q11.2 Deletion Syndrome, run by Hôpital le Vinatier at 1 site in France.
Trial summary
The study PremiCeS22 will investigate the prodromal signals at the onset of psychotic disorders of children with 22q11.2 deletion syndrome Read more about this study
- Who is it for?
- Ages 4 to 13 yearsHealthy volunteers can take part
- Conditions the study is for
- 22q11.2 Deletion Syndrome
- What is being tested?
- neuropsychological testing, questionnaires and experimental tasks
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteFrance
- Study dates
- 13 Nov 2020to 30 Sep 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 to 13 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Diagnosis of 22q11.2 deletion syndrome or no developmental disease
- Aged from 4 to 13 years old
- French language
Who cannot join
- Diagnosis of intellectual deficiency according to DSM 5 criteria
- Drug prescribed for somatic condition that could influence cerebral functioning
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Hopital Vinatier
Lyon, Auvergne-Rhône-Alpes, 69678
DEMILY MD CAROLINE, PH, 0033437915163, caroline.demily@ch-le-vinatier.fr
VIAL VERONIQUE, 0033437915531, veronique.vial@ch-le-vinatier.fr
About this study
Official title: Characterize the Behavioral Prodromes of Psychotic Disorders in Children With 22q11.2DS Aged From 4 to 13 Years Old
The study PremiCeS22 will investigate the prodromal signals at the onset of psychotic disorders of children with 22q11.2 deletion syndrome
Read the detailed description
22q11.2DS is one of the most common microdeletion syndromes (1 / 2000-1 / 4000 births) and one of the most robust genetic risk factors for schizophrenia (1 to 2% of cases). Reciprocally, approximately 30% of patients with 22q11.2DS will develop psychotic symptoms in adolescence or early adulthood. It is now well established that children and adults with 22q11.2DS have lower social skills than developing youth. These social dysfunctions could be partly underpinned by alterations in social cognitive processes, and could also be linked to the emergence of psychotic signs or even schizophrenia. However, to our knowledge, no study has investigated the existence of behavioral prodromal signs during the onset of psychotic signs in children with 22q11.2DS. In addition, the origin of social cognitive processes remains to this day little explored.
- Conditions
- 22q11.2 Deletion Syndrome
- Being tested
- neuropsychological testing, questionnaires and experimental tasks
- Medical subject headings
- DiGeorge Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
neuropsychological testing, questionnaires and experimental tasksBehavioural
Neuropsychological testing (the Sky Search subtest from the Test of Everyday Attention for Children (TEA-Ch); the Overlapping lines task of Rey; auditory attention of NEPSY II battery); questionnaires completed by the children's legal representatives to assess behavior; experimental tasks evaluating gaze direction and facial expression recognition
| Study group | Role | What they receive |
|---|---|---|
| 22q11.2DS | Experimental | Children aged from 4 to 13 years old with 22q11.2 deletion syndrome Receives: Behavioral: neuropsychological testing, questionnaires and experimental tasks |
| Control Group (Non22q11.2DS) | Active comparator | Children aged from 4 to 13 years old without developmental disease Receives: Behavioral: neuropsychological testing, questionnaires and experimental tasks |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Screen for child Anxiety Related Emotional Disorders (SCARED)
Scale assessing behavioral prodromes or warning signs of hallucinations in psychotic disorders A psychometric study is then carried out on this questionnaire in order to validate it with parents of children carrying 22q11.2DS.
Measured: Day 1
facial expression recognition task
Proportion of correct responses in experimental tasks evaluating gaze direction and facial expression recognition
Measured: Day 1
Secondary outcomes (4)
Sustained hearing attention test (Tea-Ch battery)
Proportion of impaired scaled score at the Sky Search subtest from the Test of Everyday Attention for Children (TEA-Ch)
Measured: Day 1
Rey's Tangled Lines Test
Proportion of impaired scaled score to study the degree of cognitive development in children
Measured: Day 1
NEPSY II battery
Proportion of impaired scaled score at auditory attention of NEPSY II battery The NEPSY-II is a comprehensive neuropsychological battery for children ages 3-12. The test provides measures of sensor-motor, language, visuospatial processing, memory and learning, attention/executive functions, and social cognition.
Measured: Day 1
Mean reaction time
Mean reaction time in neuropsychological testing and experimental tasks
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2020
- Study start13 Nov 2020
- Primary completion30 Jun 2026 (estimated)
- Study completion30 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 22q11.2 Deletion SyndromeStudies of the same condition, open and under way.
- More trials run by Hôpital le VinatierThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Monocentric study with two parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hôpital le Vinatier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Marie-Noëlle BABINET, Principal investigator, CH LE VINATIER
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04639388
- Sponsor's protocol ID
- 2020-A01370-39
- Acronym
- PremiCeS22
- Status last verified
- Jul 2025
- First submitted
- 1 Oct 2020
- Last updated
- 30 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Characterize the Behavioral Prodromes of Psychotic Disorders in Children With 22q11.2DS Aged From 4 to 13 Years Old
- ClinicalTrials.gov ID
- NCT04639388
- Acronym / sponsor ID
- PremiCeS22 / 2020-A01370-39
- Conditions
- 22q11.2 Deletion Syndrome
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Hôpital le VinatierUniversity, hospital or other
- Study start
- 13 Nov 2020 (actual)
- Primary completion
- 30 Jun 2026 (estimated)
- Study completion
- 30 Sep 2026 (estimated)
- First posted
- 20 Nov 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study PremiCeS22 will investigate the prodromal signals at the onset of psychotic disorders of children with 22q11.2 deletion syndrome
Detailed description
22q11.2DS is one of the most common microdeletion syndromes (1 / 2000-1 / 4000 births) and one of the most robust genetic risk factors for schizophrenia (1 to 2% of cases). Reciprocally, approximately 30% of patients with 22q11.2DS will develop psychotic symptoms in adolescence or early adulthood. It is now well established that children and adults with 22q11.2DS have lower social skills than developing youth. These social dysfunctions could be partly underpinned by alterations in social cognitive processes, and could also be linked to the emergence of psychotic signs or even schizophrenia. However, to our knowledge, no study has investigated the existence of behavioral prodromal signs during the onset of psychotic signs in children with 22q11.2DS. In addition, the origin of social cognitive processes remains to this day little explored.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Monocentric study with two parallel groups
| Arm | Type | Receives |
|---|---|---|
| 22q11.2DS | Experimental | Behavioral: neuropsychological testing, questionnaires and experimental tasksChildren aged from 4 to 13 years old with 22q11.2 deletion syndrome |
| Control Group (Non22q11.2DS) | Active comparator | Behavioral: neuropsychological testing, questionnaires and experimental tasksChildren aged from 4 to 13 years old without developmental disease |
Who may qualify
- Ages
- 4 to 13 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Diagnosis of 22q11.2 deletion syndrome or no developmental disease
- Aged from 4 to 13 years old
- French language
Key exclusion criteria (2 listed)
- Diagnosis of intellectual deficiency according to DSM 5 criteria
- Drug prescribed for somatic condition that could influence cerebral functioning
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| neuropsychological testing, questionnaires and experimental tasksNeuropsychological testing (the Sky Search subtest from the Test of Everyday Attention for Children (TEA-Ch); the Overlapping lines task of Rey; auditory attention of NEPSY II battery); questionnaires completed by the children's legal representatives to assess behavior; experimental tasks evaluating gaze direction and facial expression recognition | Behavioural | 22q11.2DS, Control Group (Non22q11.2DS) |
Primary outcome
The Screen for child Anxiety Related Emotional Disorders (SCARED)
Time frame: Day 1
Scale assessing behavioral prodromes or warning signs of hallucinations in psychotic disorders A psychometric study is then carried out on this questionnaire in order to validate it with parents of children carrying 22q11.2DS.
facial expression recognition task
Time frame: Day 1
Proportion of correct responses in experimental tasks evaluating gaze direction and facial expression recognition
4 secondary outcomes
Sustained hearing attention test (Tea-Ch battery)
Time frame: Day 1
Rey's Tangled Lines Test
Time frame: Day 1
NEPSY II battery
Time frame: Day 1
Mean reaction time
Time frame: Day 1
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2025.
- Individual participant dataSharing planned: No
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RecruitingObservational study
Examining Genetic Factors That Affect the Severity of 22q11.2 Deletion Syndrome
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RecruitingPhase 2
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Enrolling by invitation
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RecruitingPhase 2
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Marie-Noëlle BABINET principal investigator
CH LE VINATIER
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing neuropsychological testing, questionnaires and experimental tasks in people with 22q11.2 Deletion Syndrome, run by Hôpital le Vinatier at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 30 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Caroline DEMILY, MD PH (0450915163 ext. +33, caroline.demily@ch-le-vinatier.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Screen for child Anxiety Related Emotional Disorders (SCARED) (time frame: Day 1). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jul 2025; AzTrials last refreshed its copy on 8 Nov 2026.