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

22q11.2 Deletion Syndrome Clinical Trial

— PremiCeS22  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04639388
• Other study ID #: 2020-A01370-39
• Status: Recruiting
• Phase: N/A
• Start date: November 13, 2020
• Est. completion date: January 31, 2025

Study information

• Verified date: February 2024
• Source: Hôpital le Vinatier
• Contact: Caroline DEMILY, MD PH
• Phone: 0450915163
• Email: caroline.demily[@]ch-le-vinatier.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: January 31, 2025
• Est. primary completion date: October 31, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 4 Years to 13 Years

Eligibility

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

Related Conditions & MeSH terms

• 22q11.2 Deletion Syndrome
• DiGeorge Syndrome
• Mental Disorders
• Psychotic Disorders

Intervention

Behavioral:
• 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

Locations

Country	Name	City	State
France	Hopital Vinatier	Lyon	Rhone Alpes

Sponsors (1)

Lead Sponsor	Collaborator
Hôpital le Vinatier

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Day 1
Primary	facial expression recognition task	Proportion of correct responses in experimental tasks evaluating gaze direction and facial expression recognition	Day 1
Secondary	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)	Day 1
Secondary	Rey's Tangled Lines Test	Proportion of impaired scaled score to study the degree of cognitive development in children	Day 1
Secondary	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.	Day 1
Secondary	Mean reaction time	Mean reaction time in neuropsychological testing and experimental tasks	Day 1