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

Social Cognition Clinical Trial

— REF-BIP  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05922956
• Other study ID #: PI2020_843_0009
• Status: Completed
• Phase: N/A
• Start date: April 1, 2020
• Est. completion date: July 1, 2023

Study information

• Verified date: July 2023
• Source: Centre Hospitalier Universitaire, Amiens
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: July 1, 2023
• Est. primary completion date: May 1, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Bipolar Disorder
• Facies
• Social Cognition

Intervention

Other:
• Facial emotion recognition test
Facial emotion recognition test (TREF), questionnaires including self-administered questionnaires

Locations

Country	Name	City	State
France	CHU Amiens	Amiens

Sponsors (5)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire, Amiens	Centre de santé mentale MGEN, Centre Hospitalier le Vinatier, Centre Hospitalier Philippe Pinel, Amiens, Pôle Ressource Évaluation et Réhabilitation Psycho-sociale, EPSM de l'Oise

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	16 months