Social Cognition, Memory, and Executive Functions in Bipolar Disorder and Major Depressive Disorder

NCT06740331 | Recruiting

• 1 other identifier: PO24114*
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 1

Brief Summary

Bipolar disorder (BD) are common psychiatric disorders often misdiagnosed, leading to delayed treatment. Even during stable phases, individuals with bipolar disorder experience residual cognitive impairments that affect their social functioning and quality of life. This study aims to explore social cognition deficits (e.g., emotional processing, theory of mind, attribution bias) and their relationship with executive functions (e.g., flexibility, inhibition, working memory) and memory in bipolar disorder and major depressive disorder, ultimately seeking to improve understanding of their functional outcomes. Social cognition and executive functions in BD are both state- and trait-related. One recent meta-analysis demonstrated impairment in social cognitive domains for manic, depressive, and euthymic bipolar disorders' patients but it remains unclear whether these social cognitive deficits in BD are due to executive functions and/or other confounding effects. Few studies have investigated the interdependency between these cognitive impairments in these two affective disorders while a better understanding of the link between executive functions and social cognition seems crucial in order to better characterize the nature of patients' deficits and thus their caring.

Conditions

Bipolar Disorder and Major Depressive Disorder

Keywords

Bipolar disorder; major depressive disorder; high-risk individuals; social cognition; executive functions; memory functions

Outcome Measures

Primary Outcomes (1)

• Social cognition: facial emotion recognition

  Evaluated through Penn Emotion Recognition Task (Emotion Recognition, ER-40). The ER-40 asks participants to assign an emotion to 40 photographs depicting expressions of one of 5 emotions (happiness, sadness, anger, fear and neutral), 4 each of low and high intensity. Are measured the number of correct responses and type of errors.

  Day 0

Study Arms (6)

Bipolar patients

EXPERIMENTAL

Patients with a diagnosis of bipolar disorder

Behavioral: Analysis of social cognition, memory functioning, and executive functioning processes

Major depressive patients

EXPERIMENTAL

Patients with a diagnosis of major depressive disorder

Behavioral: Analysis of social cognition, memory functioning, and executive functioning processes

First-degree relatives of bipolar patients

EXPERIMENTAL

First-degree relatives of bipolar patients

Behavioral: Analysis of social cognition, memory functioning, and executive functioning processes

Bipolar controls

EXPERIMENTAL

Healthy control participants matched to group 1

Behavioral: Analysis of social cognition, memory functioning, and executive functioning processes

Depressive controls

EXPERIMENTAL

Healthy control participants matched to group 2

Behavioral: Analysis of social cognition, memory functioning, and executive functioning processes

First-degree controls

EXPERIMENTAL

Healthy control participants matched to group 3

Behavioral: Analysis of social cognition, memory functioning, and executive functioning processes

Interventions

Analysis of social cognition, memory functioning, and executive functioning processes BEHAVIORAL

Investigation of social cognition, memory functioning, and executive processes using a comprehensive clinical and cognitive assessment

Bipolar controls; Bipolar patients; Depressive controls; First-degree controls; First-degree relatives of bipolar patients; Major depressive patients

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients between 18 and 65 years old, men or women
• Having a diagnosis of bipolar disorder or depressive disorder
• No substantial change in treatment for 2 weeks preceding study enrollment
• Being a native French speaker
• Patients enrolled in the national healthcare insurance program
• Consenting to participate to the study

You may not qualify if:

• The presence of any alcohol use disorder or any other substance use disorder in the last six months, except for tobacco dependence
• A significant general medical illness, including neurological disorders or head trauma
• A sensorial impairment uncorrected (visual and/or hearing)
• Group 3: First-degree relatives of bipolar patients
• Participants between 18 and 65 years old, men or women
• Participants having at least one first-degree relative presenting an bipolar disorder (parents, children, siblings)
• Being a native French speaker
• Patients enrolled in the national healthcare insurance program
• Consenting to participate to the study
• A diagnosis of schizophrenia or of bipolar disorder or of depressive disorder according to DSM-5 criteria
• The presence of any alcohol use disorder or any other substance use disorder in the last six months, except for tobacco dependence
• A significant general medical illness, including neurological disorders or head trauma
• A sensorial impairment uncorrected (visual and/or hearing)
• Group 4, 5, 6: Healthy control participants
• Participants between 18 and 65 years old, men or women

Sponsors & Collaborators

• CHU de Reims: lead
• EPSM de la Marne: collaborator

Study Sites (1)

Chu Reims

Reims, 51092, France

RECRUITING

MeSH Terms

Conditions

Bipolar Disorder; Depressive Disorder, Major

Condition Hierarchy (Ancestors)

Bipolar and Related Disorders; Mood Disorders; Mental Disorders; Depressive Disorder

Central Study Contacts

Arthur KALADJIAN

CONTACT

03 26 78 70 45; kaladjiana@epsm-marne.fr

Sarah BARRIERE

CONTACT

03 26 78 70 45; barrieres@epsm-marne.fr

Study Design

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

Model Details: participants are assigned to one of two or more groups in parallel for the duration of the study

Study Record Dates

• First Submitted: December 13, 2024
• First Posted: December 18, 2024
• Study Start: January 7, 2025
• Primary Completion (Estimated): January 7, 2028
• Study Completion (Estimated): February 7, 2028
• Last Updated: March 13, 2026

Record last verified: 2026-03

Locations

FR (1)