NCT05922956

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2020

Longer than P75 for not_applicable

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

Study Start

First participant enrolled

April 1, 2020

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2023

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

June 20, 2023

Completed
8 days until next milestone

First Posted

Study publicly available on registry

June 28, 2023

Completed
3 days until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2023

Completed
Last Updated

November 19, 2025

Status Verified

November 1, 2025

Enrollment Period

3.1 years

First QC Date

June 20, 2023

Last Update Submit

November 17, 2025

Conditions

Keywords

social cognitionfacial emotion recognitionfacial affectbipolar disorder I and II

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (3)

patients with bipolar disorder 1

EXPERIMENTAL
Other: Facial emotion recognition test

patients with bipolar disorder 2

EXPERIMENTAL
Other: Facial emotion recognition test

healthy controls

ACTIVE COMPARATOR
Other: Facial emotion recognition test

Interventions

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

healthy controlspatients with bipolar disorder 1patients with bipolar disorder 2

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU Amiens

Amiens, 80480, France

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 20, 2023

First Posted

June 28, 2023

Study Start

April 1, 2020

Primary Completion

May 1, 2023

Study Completion

July 1, 2023

Last Updated

November 19, 2025

Record last verified: 2025-11

Data Sharing

IPD Sharing
Will not share

Locations