Understanding of Psychotic Disorders in Children With 22q11.2DS

NCT ID: NCT04639388

Last Updated: 2025-07-30

Study Results

Results pending

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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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-11-13

Study Completion Date

2026-09-30

Brief Summary

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The study PremiCeS22 will investigate the prodromal signals at the onset of psychotic disorders of children with 22q11.2 deletion syndrome

Detailed Description

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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

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22q11.2 Deletion Syndrome

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Monocentric study with two parallel groups
Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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22q11.2DS

Children aged from 4 to 13 years old with 22q11.2 deletion syndrome

Group Type EXPERIMENTAL

neuropsychological testing, questionnaires and experimental tasks

Intervention Type BEHAVIORAL

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

Control Group (Non22q11.2DS)

Children aged from 4 to 13 years old without developmental disease

Group Type ACTIVE_COMPARATOR

neuropsychological testing, questionnaires and experimental tasks

Intervention Type BEHAVIORAL

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

Interventions

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neuropsychological testing, questionnaires and experimental tasks

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

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* Diagnosis of 22q11.2 deletion syndrome or no developmental disease
* Aged from 4 to 13 years old
* French language

Exclusion Criteria

* Diagnosis of intellectual deficiency according to DSM 5 criteria
* Drug prescribed for somatic condition that could influence cerebral functioning
Minimum Eligible Age

4 Years

Maximum Eligible Age

13 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Hôpital le Vinatier

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Marie-Noëlle BABINET

Role: PRINCIPAL_INVESTIGATOR

CH LE VINATIER

Locations

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Hopital Vinatier

Lyon, Auvergne-Rhône-Alpes, France

Site Status RECRUITING

Countries

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France

Central Contacts

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Caroline DEMILY, MD PH

Role: CONTACT

0450915163 ext. +33

Véronique VIAL

Role: CONTACT

0437915531 ext. +33

Facility Contacts

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DEMILY MD CAROLINE, PH

Role: primary

0033437915163

VIAL VERONIQUE

Role: backup

0033437915531

Other Identifiers

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2020-A01370-39

Identifier Type: -

Identifier Source: org_study_id

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