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Understanding of Psychotic Disorders in Children With 22q11.2DS (PremiCeS22)

H

Hôpital le Vinatier

Status

Enrolling

Conditions

22q11.2 Deletion Syndrome

Treatments

Behavioral: neuropsychological testing, questionnaires and experimental tasks

Study type

Interventional

Funder types

Other

Identifiers

NCT04639388
2020-A01370-39

Details and patient eligibility

About

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

Full 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.

Enrollment

80 estimated patients

Sex

All

Ages

4 to 13 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Basic Science

Allocation

Non-Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

80 participants in 2 patient groups

22q11.2DS
Experimental group
Description:
Children aged from 4 to 13 years old with 22q11.2 deletion syndrome
Treatment:
Behavioral: neuropsychological testing, questionnaires and experimental tasks
Control Group (Non22q11.2DS)
Active Comparator group
Description:
Children aged from 4 to 13 years old without developmental disease
Treatment:
Behavioral: neuropsychological testing, questionnaires and experimental tasks

Trial contacts and locations

1

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Central trial contact

Véronique VIAL; Caroline DEMILY, MD PH

Data sourced from clinicaltrials.gov

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