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NCT Number: NCT04639388

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

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

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Key information

Conditions

22q11.2 Deletion Syndrome 22q11 Deletion Syndrome Abnormalities, Multiple Cardiovascular Abnormalities Cardiovascular Diseases Chromosome Disorders Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Craniofacial Abnormalities DiGeorge Syndrome Endocrine System Diseases Genetic Diseases, Inborn Heart Defects, Congenital Heart Diseases Hemic and Lymphatic Diseases Hypoparathyroidism Lymphatic Abnormalities Lymphatic Diseases Musculoskeletal Abnormalities Musculoskeletal Diseases Parathyroid Diseases

Age range

4 year–13 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

neuropsychological testing, questionnaires and experimental tasks

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

Primary outcomes

  1. 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.

  2. facial expression recognition task

    Time frame: Day 1

    Proportion of correct responses in experimental tasks evaluating gaze direction and facial expression recognition

Secondary outcomes

  1. Sustained hearing attention test (Tea-Ch battery)

    Time frame: Day 1

    Proportion of impaired scaled score at the Sky Search subtest from the Test of Everyday Attention for Children (TEA-Ch)

  2. Rey's Tangled Lines Test

    Time frame: Day 1

    Proportion of impaired scaled score to study the degree of cognitive development in children

  3. NEPSY II battery

    Time frame: Day 1

    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.

  4. Mean reaction time

    Time frame: Day 1

    Mean reaction time in neuropsychological testing and experimental tasks

Study contacts

Contact information is provided by the study sponsor or research team.

Caroline DEMILY, MD PH

CONTACT

[email protected]

0450915163 ext. +33

Véronique VIAL

CONTACT

[email protected]

0437915531 ext. +33

Sponsors and collaborators

Lead sponsor

Hôpital le Vinatier

Other

Registry information

Official study title

Characterize the Behavioral Prodromes of Psychotic Disorders in Children With 22q11.2DS Aged From 4 to 13 Years Old

Acronym: PremiCeS22

Important dates

Study start
2020
Primary completion
2026
Study completion
2026
First posted
Nov 20, 2020
Registry last updated
Jul 30, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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