NCT02423499

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
90

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started May 2015

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 3, 2015

Completed
19 days until next milestone

First Posted

Study publicly available on registry

April 22, 2015

Completed
27 days until next milestone

Study Start

First participant enrolled

May 19, 2015

Completed
6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 19, 2021

Completed
7 days until next milestone

Study Completion

Last participant's last visit for all outcomes

May 26, 2021

Completed
Last Updated

June 15, 2026

Status Verified

June 1, 2026

Enrollment Period

6 years

First QC Date

April 3, 2015

Last Update Submit

June 11, 2026

Conditions

Keywords

Autism Spectrum DisorderBipolar DisorderEmotions

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (4)

  • 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

Study Arms (3)

Autism Spectrum Disorder

Autism Spectrum Disorder adults without intellectual disability

Bipolar Disorder

Bipolar Disorder adults during normothymic phase of illness

Healthy Volonteers

Healthy adults

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-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.

You may qualify if:

  • 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:
  • +5 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

LEMAIRE

Tours, 37044, France

Location

MeSH Terms

Conditions

Autism Spectrum DisorderBipolar Disorder

Condition Hierarchy (Ancestors)

Child Development Disorders, PervasiveNeurodevelopmental DisordersMental DisordersBipolar and Related DisordersMood Disorders

Study Officials

  • 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

    PRINCIPAL INVESTIGATOR
  • Mathieu LEMAIRE, MD-PHD

    University Center of Child and Adolescent Psychiatry, University Hospital of Tours

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 3, 2015

First Posted

April 22, 2015

Study Start

May 19, 2015

Primary Completion

May 19, 2021

Study Completion

May 26, 2021

Last Updated

June 15, 2026

Record last verified: 2026-06

Locations