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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05922956
Recruitment Status : Completed
First Posted : June 28, 2023
Last Update Posted : July 12, 2023
Sponsor:
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
Information provided by (Responsible Party):
Centre Hospitalier Universitaire, Amiens

Study Description
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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.


Condition or disease Intervention/treatment Phase
Social Cognition Facial Emotion Recognition Facial Affect Bipolar Disorder I and II Other: Facial emotion recognition test Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Facial Emotion Recognition in Patients With Euthymic Bipolar Disorder I and II
Actual Study Start Date : April 1, 2020
Actual Primary Completion Date : May 1, 2023
Actual Study Completion Date : July 1, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bipolar Disorder

Arms and Interventions
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Arm Intervention/treatment
Experimental: patients with bipolar disorder 1 Other: Facial emotion recognition test
Facial emotion recognition test (TREF), questionnaires including self-administered questionnaires
Experimental: patients with bipolar disorder 2 Other: Facial emotion recognition test
Facial emotion recognition test (TREF), questionnaires including self-administered questionnaires
Active Comparator: healthy controls Other: Facial emotion recognition test
Facial emotion recognition test (TREF), questionnaires including self-administered questionnaires


Outcome Measures
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Primary Outcome Measures :
  1. variation of TREF scores in tree groups of subjects [ Time Frame: 16 months ]
    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.


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05922956


Locations
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France
CHU Amiens
Amiens, France, 80480
Sponsors and Collaborators
Centre Hospitalier Universitaire, Amiens
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
More Information
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Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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Responsible Party: Centre Hospitalier Universitaire, Amiens
ClinicalTrials.gov Identifier: NCT05922956    
Other Study ID Numbers: PI2020_843_0009
First Posted: June 28, 2023    Key Record Dates
Last Update Posted: July 12, 2023
Last Verified: July 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Centre Hospitalier Universitaire, Amiens:
social cognition
facial emotion recognition
facial affect
bipolar disorder I and II
Additional relevant MeSH terms:
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Facies
Bipolar Disorder
Bipolar and Related Disorders
Mood Disorders
 Mental Disorders
Disease Attributes
Pathologic Processes