NCT04280367

Brief Summary

The primary objective of the study aims to study transition toward schizophrenia in patients with learning disorders, and to compare the risk between patients with specific learning disorders, and patients with complexed learning disorders (by two types: patients with other neuro-developmental disorders including executive function disorders, and patients with anxiety).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jan 2020

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 28, 2020

Completed
23 days until next milestone

First Submitted

Initial submission to the registry

February 20, 2020

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 21, 2020

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 29, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 29, 2020

Completed
Last Updated

August 22, 2023

Status Verified

August 1, 2023

Enrollment Period

4 months

First QC Date

February 20, 2020

Last Update Submit

August 21, 2023

Conditions

Keywords

learning disordersexecutive function disorderspsychosischildrenadult-age

Outcome Measures

Primary Outcomes (1)

  • Semi-structured interview

    Assessement with Comprehensive Assessment of At-Risk Mental States (CAARMS) during 6 to 90 minutes at the center of Raymond Poincaré hospital. The unique collection during the interview, quotation of each patient will be given from the assessement. There will be 4 groups by the results: CAARMS negative subjects, vulnerable subjects, attenuated psychosis subjects and subjects with brief and limited intermittent psychotic syndrome. The further statistic comparison will be done between the 3 last groups classified with results of CAARMS.

    At baseline

Secondary Outcomes (3)

  • Autistic screening

    At baseline

  • Anxiety measuring

    At baseline

  • Social interaction difficulty evaluation

    At baseline

Study Arms (3)

Comparator group

Specific learning disorders group

Diagnostic Test: Standardised semi-structured talkDiagnostic Test: Autistic spectre disorder screeningDiagnostic Test: Anxiety measuring

neuro-developmental complexed group

Group of neuro-developmental complexe of learning

Diagnostic Test: Standardised semi-structured talkDiagnostic Test: Autistic spectre disorder screeningDiagnostic Test: Anxiety measuring

Complexed with anxiety

Disorders in learning with anxiety

Diagnostic Test: Standardised semi-structured talkDiagnostic Test: Autistic spectre disorder screeningDiagnostic Test: Anxiety measuring

Interventions

Comprehensive assessment of at-risk mental states (CAARMS) will be used.

Comparator groupComplexed with anxietyneuro-developmental complexed group

Autism-spectrum quotient (AQ) auto-questionnaire will be used.

Comparator groupComplexed with anxietyneuro-developmental complexed group
Anxiety measuringDIAGNOSTIC_TEST

An inventory for measuring clinical anxiety: Beck Anxiety Inventory (BAI); Liebowitz Social Anxiety Scale.

Comparator groupComplexed with anxietyneuro-developmental complexed group

Eligibility Criteria

Age15 Years - 30 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Patients between 15 and 30 years, suffering learning disorders complicated with two orders: with other neuro-developmental, or with anxiety (vs specific: comparator group).

You may qualify if:

  • Patients born between 1990 and 2005, have been cared by Dr Schlumberger in 2014 in the center of language and learning disorders at Raymond Poincaré hospital;
  • With severe learning disorders: deficiency in school work, need at least one medical appointment and long-term rehabilitation in the center of language and learning disorders at Raymond Poincaré hospital;
  • Affiliated to a social protection schema;
  • Written informed consent signed.

You may not qualify if:

  • Absence of learning disorder;
  • Intellectual deficiency;
  • Epilepsia;
  • Patients who will performed follow-up at Chartres city;
  • Patients under guardianship or curatorship;
  • Foreign patients under AME schema, a medical help from the state in France.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre de référence des troubles du langage et des apprentissages, Hôpital Raymond Poincaré

Garches, 92380, France

Location

MeSH Terms

Conditions

SchizophreniaLearning DisabilitiesPsychotic Disorders

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental DisordersCommunication DisordersNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsNeurodevelopmental Disorders

Study Officials

  • Emilie SCHLUMBERGER, MD

    Centre de référence des troubles du langage et des apprentissages, Hôpital Raymond Poincaré, APHP

    PRINCIPAL INVESTIGATOR
  • Albane Mansoux

    Centre de référence des troubles du langage et des apprentissages, Hôpital Raymond Poincaré, APHP

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 20, 2020

First Posted

February 21, 2020

Study Start

January 28, 2020

Primary Completion

May 29, 2020

Study Completion

May 29, 2020

Last Updated

August 22, 2023

Record last verified: 2023-08

Data Sharing

IPD Sharing
Will not share

Locations