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

Overview

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

Full Title of Study: “Characterize the Behavioral Prodromes of Psychotic Disorders in Children With 22q11.2DS Aged From 4 to 13 Years Old”

Study Type

• Study Type: Interventional
• Study Design
  • Allocation: Non-Randomized
  • Intervention Model: Parallel Assignment
  • Primary Purpose: Basic Science
  • Masking: None (Open Label)
• Study Primary Completion Date: October 31, 2024

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.

Interventions

• 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

Arms, Groups and Cohorts

• Experimental: 22q11.2DS
  • Children aged from 4 to 13 years old with 22q11.2 deletion syndrome
• Active Comparator: Control Group (Non22q11.2DS)
  • Children aged from 4 to 13 years old without developmental disease

Clinical Trial Outcome Measures

Primary Measures

• 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

Secondary Measures

• 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)
• Rey’s Tangled Lines Test
  • Time Frame: Day 1
  • Proportion of impaired scaled score to study the degree of cognitive development in children
• 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.
• Mean reaction time
  • Time Frame: Day 1
  • Mean reaction time in neuropsychological testing and experimental tasks

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 4 Years

Maximum Age: 13 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

• Lead Sponsor
  • Hôpital le Vinatier
• Provider of Information About this Clinical Study
  • Sponsor
• Overall Official(s)
  • Marie-Noëlle BABINET, Principal Investigator, CH LE VINATIER
• Overall Contact(s)
  • Caroline DEMILY, MD PH, 0450915163, caroline.demily@ch-le-vinatier.fr