Clinical trial NCT02423499: Features Emotional Responses in Adults With Autism: Comparison With Bipolar Disorder (REMBAU)
Official title: Features Emotional Responses in Adults With Autism: Comparison With Bipolar Disorder
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Autism Spectrum Disorder
Bipolar Disorder
Keywords: Autism Spectrum Disorder
Bipolar Disorder
Emotions
Lead sponsor: University Hospital, Tours
Sponsor class: OTHER
First posted: 2015-04-22
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.


Eligibility criteria: 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

Primary outcomes:
measure: 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
timeFrame: average 1 hour
Secondary outcomes:
measure: Subjective emotional response during emotion elicitation in a laboratory session
timeFrame: average 1 hour
measure: Facial emotional response during emotion elicitation in a laboratory session
timeFrame: average 1 hour
measure: Experience sampling method in real life during a week (emotions, activities, social context, burden)
timeFrame: within the first 7 days after inclusion
measure: Physiological emotional response in real life (heart rate, electrodermal response, breath rate, actimetry)
timeFrame: within the first 24h approx. after inclusion
Other outcomes:
Locations:
city: Tours
country: France
facility: LEMAIRE
Study officials:
affiliation: University Center of Child and Adolescent Psychiatry, University Hospital of Tours
name: Frédérique BONNET- BRILHAULT, Pr
role: PRINCIPAL_INVESTIGATOR
affiliation: University Psychiatric Clinic, University Hospital of Tours
name: Wissam EL-HAGE, Pr
role: PRINCIPAL_INVESTIGATOR
affiliation: Clinical Investigation Center, INSERM 14 15, University Hospital of Tours
name: Valérie GISSOT, MD-PHD
role: PRINCIPAL_INVESTIGATOR
affiliation: University Center of Child and Adolescent Psychiatry, University Hospital of Tours
name: Mathieu LEMAIRE, MD-PHD
role: STUDY_DIRECTOR
References: