Features Emotional Responses in Adults With Autism: Comparison With Bipolar Disorder (REMBAU)

Sponsor
University Hospital, Tours (Other)
Overall Status
Recruiting
CT.gov ID
NCT02423499
Collaborator
(none)
90
1
72.2
1.2

Study Details

Study Description

Brief Summary

The objective of this study is to identify the specific characteristics of Autism Spectrum Disorder (ASD) in emotional response profiles and shared with Bipolar Disorder (BD) characteristics.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    90 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Features Emotional Responses in Adults With Autism: Comparison With Bipolar Disorder
    Actual Study Start Date :
    May 19, 2015
    Anticipated Primary Completion Date :
    May 26, 2021
    Anticipated Study Completion Date :
    May 26, 2021

    Arms and Interventions

    Arm Intervention/Treatment
    Autism Spectrum Disorder

    Autism Spectrum Disorder adults without intellectual disability

    Bipolar Disorder

    Bipolar Disorder adults during normothymic phase of illness

    Healthy Volonteers

    Healthy adults

    Outcome Measures

    Primary Outcome Measures

    1. Physiological emotional response during emotion elicitation in a laboratory session (Pupil size measured by eye tracking, heart rate, electrodermal response, breath rate) during emotion elicitation in a laboratory session [average 1 hour]

    Secondary Outcome Measures

    1. Subjective emotional response during emotion elicitation in a laboratory session [average 1 hour]

    2. Facial emotional response during emotion elicitation in a laboratory session [average 1 hour]

    3. Experience sampling method in real life during a week (emotions, activities, social context, burden) [within the first 7 days after inclusion]

    4. Physiological emotional response in real life (heart rate, electrodermal response, breath rate, actimetry) [within the first 24h approx. after inclusion]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 50 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:
    • For all participants:

    • Age between 18 and 50 years

    • Normal vision (or corrected)

    • Absence of neurological disorder (epilepsy , head trauma, ... )

    • Ability to understand information about the protocol

    • Informed and signed consent

    • normal mood (euthymia)

    • normal or high intelligence

    • Subjects with ASD:

    • Subjects with an autism spectrum disorder according to the DSM-5

    • The diagnosis is confirmed by diagnostic interviews: ADI- R (Autism Diagnostic Interview-Revised) and / or ADOS (Autism Diagnostic Observation Schedule ) .

    • Subjects with bipolar disorder:

    • Diagnosis of bipolar disorder according to DSM-IV-TR or DSM -5

    • The diagnosis is confirmed by the MINI 6.0 (The Mini-International Neuropsychiatric Interview) .

    • Healthy volunteers:

    • Inclusion after checking the national register of healthy volunteers

    • No history of disease of the central nervous system or psychiatric disorder

    • No family history of ASD or BD in the first degree

    • Lack of psychotropic medication or current cardiotropic

    • Lack of psychiatric disorder on Axis I MINI 6.0

    • AQ Score < 32

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 LEMAIRE Tours France 37044

    Sponsors and Collaborators

    • University Hospital, Tours

    Investigators

    • Principal Investigator: Frédérique BONNET- BRILHAULT, Pr, University Center of Child and Adolescent Psychiatry, University Hospital of Tours
    • Principal Investigator: Wissam EL-HAGE, Pr, University Psychiatric Clinic, University Hospital of Tours
    • Principal Investigator: Valérie GISSOT, MD-PHD, Clinical Investigation Center, INSERM 14 15, University Hospital of Tours
    • Study Director: Mathieu LEMAIRE, MD-PHD, University Center of Child and Adolescent Psychiatry, University Hospital of Tours

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    University Hospital, Tours
    ClinicalTrials.gov Identifier:
    NCT02423499
    Other Study ID Numbers:
    • PHAO13-ML/REMBAU
    • 2014-A00431-46
    First Posted:
    Apr 22, 2015
    Last Update Posted:
    May 12, 2021
    Last Verified:
    May 1, 2021
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by University Hospital, Tours
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of May 12, 2021