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Facial Emotion Recognition in Patients With Euthymic Bipolar Disorder I and II (REF-BIP)

Primary Purpose

Social Cognition, Facial Emotion Recognition, Facial Affect

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Facial emotion recognition test
Sponsored by
Centre Hospitalier Universitaire, Amiens
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Social Cognition focused on measuring social cognition, facial emotion recognition, facial affect, bipolar disorder I and II

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: Patient group : Male or female patients, between 18 and 60 years old Diagnosis of Bipolar Disorder I or Bipolar Disorder II according to DSM-IV criteria, using the French version of the Mini-International Neuropsychiatric Interview (MINI) Strictly euthymic defined by Hamilton Depression Rating Scale (17 items) ≤ 5 and Young Mania Rating Scale ≤ 5 for at least two months. Native French speakers Affiliated to the French social security system Giving their written informed consent Control group : Male or female control subjects, aged between 18 and 60 years old, assessed using TREF Native French speakers Giving their written informed consent Exclusion Criteria: Patient group : History of mental retardation assessed by the French version of the National Adult Reading Test Neurological illness or any clinical condition that could affect cognitive performance (history of head injury with loss of consciousness lasting more than 5 minutes multiple sclerosis, stroke etc.) Electroconvulsive therapy within the last 6 months Alcohol and Drug dependence (except tobacco and caffeine) according to DSM-IV criteria using the French version of the Mini-International Neuropsychiatric Interview (MINI). Learning disability or difficulty with fluent use of the French language Patient with mandatory care Long-Term use of non-psychotropic medication with psychotropic effects (opiates, Baclofen) Control group : History of mental retardation estimated by the French version of the National Adult Reading Test Neurological illness or any clinical condition that could affect cognitive performance (history of head injury with loss of consciousness lasting more than 5 minutes multiple sclerosis, stroke etc.) Current Mood disorder/ Lifetime Psychotic Disorder according to DSM-IV criteria using the French version of the Mini-International Neuropsychiatric Interview (MINI) Neither history of psychotic or affective disorders in a first-degree family member Alcohol and Drug dependence (except tobacco and caffeine) according to DSM-IV criteria using the French version of the Mini-International Neuropsychiatric Interview (MINI) Learning disability or difficulty with fluent use of the French language Long-Term use of non-psychotropic drugs with psychotropic effects (opiates, Baclofen) and psychotropic drugs

Sites / Locations

  • CHU Amiens

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Active Comparator

Arm Label

patients with bipolar disorder 1

patients with bipolar disorder 2

healthy controls

Arm Description

Outcomes

Primary Outcome Measures

variation of TREF scores in tree groups of subjects
TREF scores in tree groups of subjects (group of patients with bipolar disorder 1, group of patients with bipolar disorder 2 and group of healthy controls.

Secondary Outcome Measures

Full Information

First Posted
June 20, 2023
Last Updated
July 11, 2023
Sponsor
Centre Hospitalier Universitaire, Amiens
Collaborators
Centre Hospitalier le Vinatier, Pôle Ressource Évaluation et Réhabilitation Psycho-sociale, EPSM de l'Oise, Centre de santé mentale MGEN, Centre Hospitalier Philippe Pinel, Amiens
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1. Study Identification

Unique Protocol Identification Number
NCT05922956
Brief Title
Facial Emotion Recognition in Patients With Euthymic Bipolar Disorder I and II
Acronym
REF-BIP
Official Title
Facial Emotion Recognition in Patients With Euthymic Bipolar Disorder I and II
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Completed
Study Start Date
April 1, 2020 (Actual)
Primary Completion Date
May 1, 2023 (Actual)
Study Completion Date
July 1, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire, Amiens
Collaborators
Centre Hospitalier le Vinatier, Pôle Ressource Évaluation et Réhabilitation Psycho-sociale, EPSM de l'Oise, Centre de santé mentale MGEN, Centre Hospitalier Philippe Pinel, Amiens

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The facial emotion recognition is a basic social skill for successful social interactions. Several meta-analyses and recent studies found impairments of the perception of facial emotions in patients with euthymic bipolar disorder. Few studies compared recognition of facial emotions impairments during euthymia in patients with bipolar disorder type 1 and 2. These studies included low population samples (N<60). There were discrepancies in results of these studies. Szanto suggested that facial emotion recognition impairments were correlated with suicidal risk and social isolation. These impairments should be taking into account regarding psycho-social treatments in patients with bipolar disorder. This study aims to evaluate facial emotion recognition in patients with bipolar I and II disorders compared to healthy controls, using the facial emotion recognition test (TREF). The objective of the present study is to compare TREF scores in a group of patients with bipolar 1, a group of patients with bipolar 2 disorder and a group with healthy controls. In addition, the investigators will investigate the relationships between TREF scores and levels of self-esteem and mental well-being.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Social Cognition, Facial Emotion Recognition, Facial Affect, Bipolar Disorder I and II
Keywords
social cognition, facial emotion recognition, facial affect, bipolar disorder I and II

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
10 (Actual)

8. Arms, Groups, and Interventions

Arm Title
patients with bipolar disorder 1
Arm Type
Experimental
Arm Title
patients with bipolar disorder 2
Arm Type
Experimental
Arm Title
healthy controls
Arm Type
Active Comparator
Intervention Type
Other
Intervention Name(s)
Facial emotion recognition test
Intervention Description
Facial emotion recognition test (TREF), questionnaires including self-administered questionnaires
Primary Outcome Measure Information:
Title
variation of TREF scores in tree groups of subjects
Description
TREF scores in tree groups of subjects (group of patients with bipolar disorder 1, group of patients with bipolar disorder 2 and group of healthy controls.
Time Frame
16 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Patient group : Male or female patients, between 18 and 60 years old Diagnosis of Bipolar Disorder I or Bipolar Disorder II according to DSM-IV criteria, using the French version of the Mini-International Neuropsychiatric Interview (MINI) Strictly euthymic defined by Hamilton Depression Rating Scale (17 items) ≤ 5 and Young Mania Rating Scale ≤ 5 for at least two months. Native French speakers Affiliated to the French social security system Giving their written informed consent Control group : Male or female control subjects, aged between 18 and 60 years old, assessed using TREF Native French speakers Giving their written informed consent Exclusion Criteria: Patient group : History of mental retardation assessed by the French version of the National Adult Reading Test Neurological illness or any clinical condition that could affect cognitive performance (history of head injury with loss of consciousness lasting more than 5 minutes multiple sclerosis, stroke etc.) Electroconvulsive therapy within the last 6 months Alcohol and Drug dependence (except tobacco and caffeine) according to DSM-IV criteria using the French version of the Mini-International Neuropsychiatric Interview (MINI). Learning disability or difficulty with fluent use of the French language Patient with mandatory care Long-Term use of non-psychotropic medication with psychotropic effects (opiates, Baclofen) Control group : History of mental retardation estimated by the French version of the National Adult Reading Test Neurological illness or any clinical condition that could affect cognitive performance (history of head injury with loss of consciousness lasting more than 5 minutes multiple sclerosis, stroke etc.) Current Mood disorder/ Lifetime Psychotic Disorder according to DSM-IV criteria using the French version of the Mini-International Neuropsychiatric Interview (MINI) Neither history of psychotic or affective disorders in a first-degree family member Alcohol and Drug dependence (except tobacco and caffeine) according to DSM-IV criteria using the French version of the Mini-International Neuropsychiatric Interview (MINI) Learning disability or difficulty with fluent use of the French language Long-Term use of non-psychotropic drugs with psychotropic effects (opiates, Baclofen) and psychotropic drugs
Facility Information:
Facility Name
CHU Amiens
City
Amiens
ZIP/Postal Code
80480
Country
France

12. IPD Sharing Statement

Plan to Share IPD
No

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Facial Emotion Recognition in Patients With Euthymic Bipolar Disorder I and II

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