- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02423499
Features Emotional Responses in Adults With Autism: Comparison With Bipolar Disorder (REMBAU) (REMBAU)
May 11, 2021 updated by: University Hospital, Tours
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
Study Type
Observational
Enrollment (Anticipated)
90
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
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
-
-
-
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
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
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
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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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
Time Frame: average 1 hour
|
average 1 hour
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Subjective emotional response during emotion elicitation in a laboratory session
Time Frame: average 1 hour
|
average 1 hour
|
Facial emotional response during emotion elicitation in a laboratory session
Time Frame: average 1 hour
|
average 1 hour
|
Experience sampling method in real life during a week (emotions, activities, social context, burden)
Time Frame: within the first 7 days after inclusion
|
within the first 7 days after inclusion
|
Physiological emotional response in real life (heart rate, electrodermal response, breath rate, actimetry)
Time Frame: within the first 24h approx. after inclusion
|
within the first 24h approx. after inclusion
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
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
Additional Relevant MeSH Terms
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
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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