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

Bipolar Disorder Clinical Trial

— REMBAU  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02423499
• Other study ID #: PHAO13-ML/REMBAU
• Secondary ID: 2014-A00431-46
• Status: Recruiting
• Start date: May 19, 2015
• Est. completion date: May 26, 2021

Study information

• Verified date: May 2021
• Source: University Hospital, Tours
• Contact: Mathieu LEMAIRE, MD-PHD
• Phone: 0033247478763
• Email: mathieu.lemaire[@]univ-tours.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 90
• Est. completion date: May 26, 2021
• Est. primary completion date: May 26, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Autism Spectrum Disorder
• Autistic Disorder
• Bipolar Disorder
• Disease

Locations

Country	Name	City	State
France	LEMAIRE	Tours

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Tours

Country where clinical trial is conducted

France, 

Outcome

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