Autism Spectrum DisorderREMBAUNCT02423499
Features Emotional Responses in Adults With Autism: Comparison With Bipolar Disorder (REMBAU)
An observational study of Autism Spectrum Disorder and Bipolar Disorder, run by University Hospital, Tours at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Autism Spectrum Disorder, Bipolar Disorder
- How many people
- 90 participants
- Where
- 1 siteFrance
- Study dates
- 19 May 2015to 26 May 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
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.
Who may be able to join
- 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
Show all 21Show fewer
- 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
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Autism Spectrum Disorder, Bipolar Disorder
- Keywords
- Autism Spectrum Disorder, Bipolar Disorder, Emotions
- Medical subject headings
- Autism Spectrum Disorder, Bipolar Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: average 1 hour
Secondary outcomes (4)
Subjective emotional response during emotion elicitation in a laboratory session
Measured: average 1 hour
Facial emotional response during emotion elicitation in a laboratory session
Measured: average 1 hour
Experience sampling method in real life during a week (emotions, activities, social context, burden)
Measured: within the first 7 days after inclusion
Physiological emotional response in real life (heart rate, electrodermal response, breath rate, actimetry)
Measured: within the first 24h approx. after inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2015 (estimated)
- Study start19 May 2015
- Primary completion19 May 2021
- Study completion26 May 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Autism Spectrum DisorderStudies of the same condition, open and under way.
- More trials run by University Hospital, ToursThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Tours
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Frédérique BONNET- BRILHAULT, Pr, Principal investigator, University Center of Child and Adolescent Psychiatry, University Hospital of ToursWissam EL-HAGE, Pr, Principal investigator, University Psychiatric Clinic, University Hospital of ToursValérie GISSOT, MD-PHD, Principal investigator, Clinical Investigation Center, INSERM 14 15, University Hospital of ToursMathieu LEMAIRE, MD-PHD, Study director, University Center of Child and Adolescent Psychiatry, University Hospital of Tours
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02423499
- Sponsor's protocol ID
- PHAO13-ML/REMBAU
- Other IDs
- 2014-A00431-46
- Acronym
- REMBAU
- Status last verified
- Jun 2026
- First submitted
- 3 Apr 2015
- Last updated
- 15 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Features Emotional Responses in Adults With Autism: Comparison With Bipolar Disorder
- ClinicalTrials.gov ID
- NCT02423499
- Acronym / sponsor ID
- REMBAU / PHAO13-ML/REMBAU
- Conditions
- Autism Spectrum Disorder, Bipolar Disorder
- Keywords
- Autism Spectrum Disorder, Bipolar Disorder, Emotions
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- University Hospital, ToursUniversity, hospital or other
- Study start
- 19 May 2015 (actual)
- Primary completion
- 19 May 2021 (actual)
- Study completion
- 26 May 2021 (actual)
- First posted
- 22 Apr 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Autism Spectrum Disorder | – | –Autism Spectrum Disorder adults without intellectual disability |
| Bipolar Disorder | – | –Bipolar Disorder adults during normothymic phase of illness |
| Healthy Volonteers | – | –Healthy adults |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- 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.
Key inclusion criteria (21 listed)
- For all participants:
- Subjects with ASD:
- Subjects with bipolar disorder:
- Healthy volunteers:
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
4 secondary outcomes
Subjective emotional response during emotion elicitation in a laboratory session
Time frame: average 1 hour
Facial emotional response during emotion elicitation in a laboratory session
Time frame: 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
Physiological emotional response in real life (heart rate, electrodermal response, breath rate, actimetry)
Time frame: within the first 24h approx. after inclusion
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Frédérique BONNET- BRILHAULT, Pr principal investigator
University Center of Child and Adolescent Psychiatry, University Hospital of Tours
Wissam EL-HAGE, Pr principal investigator
University Psychiatric Clinic, University Hospital of Tours
Valérie GISSOT, MD-PHD principal investigator
Clinical Investigation Center, INSERM 14 15, University Hospital of Tours
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Autism Spectrum Disorder and Bipolar Disorder, run by University Hospital, Tours at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 21 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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 (time frame: average 1 hour). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jun 2026.