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

Features Emotional Responses in Adults With Autism: Comparison With Bipolar Disorder

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.

Study Overview

• Status: Recruiting
• Conditions: Bipolar Disorder; Autism Spectrum Disorder

• Study Type: Observational
• Enrollment (Anticipated): 90

Contacts and Locations

• Study Contact: Name: Mathieu LEMAIRE, MD-PHD; Phone Number: 0033247478763; Email: mathieu.lemaire@univ-tours.fr
• Study Contact Backup: Name: Frédérique BONNET-BRILHAULT, Pr; Phone Number: 0033247478412; Email: frederique.brilhault@univ-tours.fr

Study Locations

• France
  • Tours, France, 37044
    • Recruiting
    • LEMAIRE
    • Contact: MATHIEU LEMAIRE, MD-PHD; Phone Number: 00330247478763; Email: mathieu.lemaire@univ-tours.fr
    • Contact: Frédérique BONNET-BRILHAULT, MD-PHD; Phone Number: 0033247478412; Email: frederique.brilhault@univ-tours.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

ASD subjects will be recruited at Centre Universitaire de Pédopsychiatrie, CHRU de Tours, FRANCE.

BD subjects will be recruited at Clinique Psychiatrique Universitaire, CHRU de Tours, FRANCE.

Healthy volunteers will be recruited at Centre d'Inverstigation Clinique, CHRU de Tours, FRANCE.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort
Autism Spectrum Disorder; Autism Spectrum Disorder adults without intellectual disability
Bipolar Disorder; Bipolar Disorder adults during normothymic phase of illness
Healthy Volonteers; Healthy adults

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Outcome Measure	Time Frame
Subjective emotional response during emotion elicitation in a laboratory session	average 1 hour
Facial emotional response during emotion elicitation in a laboratory session	average 1 hour
Experience sampling method in real life during a week (emotions, activities, social context, burden)	within the first 7 days after inclusion
Physiological emotional response in real life (heart rate, electrodermal response, breath rate, actimetry)	within the first 24h approx. after inclusion

Collaborators and Investigators

• Sponsor: 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 record dates

Study Major Dates

• Study Start (Actual): May 19, 2015
• Primary Completion (Anticipated): May 26, 2021
• Study Completion (Anticipated): May 26, 2021

Study Registration Dates

• First Submitted: April 3, 2015
• First Submitted That Met QC Criteria: April 17, 2015
• First Posted (Estimate): April 22, 2015

Study Record Updates

• Last Update Posted (Actual): May 12, 2021
• Last Update Submitted That Met QC Criteria: May 11, 2021
• Last Verified: May 1, 2021

More Information

Terms related to this study

• Keywords: Bipolar Disorder; Emotions; Autism Spectrum Disorder
• Additional Relevant MeSH Terms: Mental Disorders; Pathologic Processes; Bipolar and Related Disorders; Neurodevelopmental Disorders; Child Development Disorders, Pervasive; Disease; Bipolar Disorder; Autistic Disorder; Autism Spectrum Disorder
• Other Study ID Numbers: PHAO13-ML/REMBAU; 2014-A00431-46 (Other Identifier: EudraCT number)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No