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

Sponsor
Hôpital le Vinatier (Other)
Overall Status
Recruiting
CT.gov ID
NCT04639388
Collaborator
(none)
80
Enrollment
1
Location
2
Arms
50.6
Anticipated Duration (Months)
1.6
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Behavioral: neuropsychological testing, questionnaires and experimental tasks
 N/A

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
80 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Monocentric study with two parallel groupsMonocentric study with two parallel groups
Masking:
None (Open Label)
Primary Purpose:
Basic Science
Official Title:
Characterize the Behavioral Prodromes of Psychotic Disorders in Children With 22q11.2DS Aged From 4 to 13 Years Old
Actual Study Start Date :
Nov 13, 2020
Anticipated Primary Completion Date :
Oct 31, 2024
Anticipated Study Completion Date :
Jan 31, 2025

Arms and Interventions

Arm Intervention/Treatment
Experimental: 22q11.2DS

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

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
Active Comparator: Control Group (Non22q11.2DS)

Children aged from 4 to 13 years old without developmental disease

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

Outcome Measures

Primary Outcome Measures

  1. The Screen for child Anxiety Related Emotional Disorders (SCARED) [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 [Day 1]

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

Secondary Outcome Measures

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

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

  3. NEPSY II battery [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 [Day 1]

    Mean reaction time in neuropsychological testing and experimental tasks

Eligibility Criteria

Criteria

Ages Eligible for Study:
4 Years to 13 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Hopital Vinatier Lyon Rhone Alpes France 69678

Sponsors and Collaborators

  • Hôpital le Vinatier

Investigators

  • Principal Investigator: Marie-Noëlle BABINET, CH LE VINATIER

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Hôpital le Vinatier
ClinicalTrials.gov Identifier:
NCT04639388
Other Study ID Numbers:
  • 2020-A01370-39
First Posted:
Nov 20, 2020
Last Update Posted:
Jan 27, 2022
Last Verified:
Jan 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
DiGeorge Syndrome
Mental Disorders
Psychotic Disorders

Study Results

No Results Posted as of Jan 27, 2022