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

March 11, 2026 updated by: CHU de Reims

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Bipolar Disorders (BD) and Major Depressive Disorder (MDD) are two of the most common psychiatric disorders worldwide. BD is characterized by severe mood fluctuations (i.e., hypomanic/manic and depressive episodes) and can often be misdiagnosed as MDD, leading to delays in proper diagnosis. This is because the most common initial presentation of BD is a depressive episode. Such delays result in less appropriate care and support.

In addition to delayed diagnoses, the periods between symptomatic episodes, which are considered "stable," are not without challenges. Even during these euthymic periods, individuals often experience residual difficulties that impact their daily functioning. While these periods are viewed as symptom-free, it's clear that individuals still do not experience a significantly improved quality of life. Functional outcomes (e.g., occupational and social functioning) are often impaired and distinguishing between BD and MDD more clearly could improve care and enhance their quality of life. Identifying distinctive markers is essential for improving treatment strategies.

Cognitive functions might serve as trait markers of the disorders because they are impaired both during acute episodes and euthymic phases. These cognitive impairments could also predict functional outcomes in BD. Cognitive profiles may also help distinguish between BD and MDD. While impairments in executive functions, such as the ability to adapt to new situations (e.g., task-switching) and episodic memory (i.e., memory of specific personal events), are present even during euthymic phases of BD, this is not always the case for social cognition (e.g., facial emotion recognition). These cognitive alterations are highly heterogeneous across patients, and identifying their cognitive profiles could provide valuable insights.

Studying the links between cognitive components in BD and MDD may lead to a better understanding how cognitive functions are impacted in these mood disorders, and especially to understand the interactions between these different functions. Additionally, considering clinical symptomatology (e.g., the number of episodes) and other factors (e.g., anxiety, childhood trauma, social support) could offer a more comprehensive understanding of these disorders.

In addition to focusing on these two clinical populations, we will also include first-degree relatives of individuals with bipolar disorder. Indeed, it seems that these relatives may also experience mild cognitive impairments, and we aim to further investigate these hypotheses.

This project aims to better understand social cognition impairments (e.g., emotion processing, theory of mind, attribution bias) and their relationship with verbal episodic memory and executive functions (e.g., working memory, cognitive flexibility) in BD and MDD. It will also explore how these cognitive processes affect functional outcomes in these groups.

A first visit will be dedicated to the collection of clinical data. During the second visit, the investigators will conduct a comprehensive neuropsychological assessment to evaluate executive functions, episodic memory, and all components of social cognition. This protocol will allow the investigators to study all these variables together and to clarify and better understand the connections between them.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
180

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • France
      • Reims, France, 51092
        • Recruiting
        • Chu Reims
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion criteria:

  • 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

Exclusion 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 3: First-degree relatives of bipolar patients

Inclusion criteria:

  • 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

Exclusion criteria:

  • 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

Inclusion criteria:

  • Participants between 18 and 65 years old, men or women
  • Being a native French speaker
  • Patients enrolled in the national healthcare insurance program
  • Consenting to participate to the study

Exclusion criteria:

  • A diagnosis of schizophrenia or of bipolar disorder or of major 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
  • Participants having one first-degree relative presenting an bipolar disorder or depressive disorder or schizophrenia according to DSM-5 criteria
  • A significant general medical illness, including neurological disorders or head trauma
  • A sensorial impairment uncorrected (visual and/or hearing)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: First-degree controls
Healthy control participants matched to group 3
Behavioral: Analysis of social cognition, memory functioning, and executive functioning processes
Investigation of social cognition, memory functioning, and executive processes using a comprehensive clinical and cognitive assessment
Experimental: Bipolar patients
Patients with a diagnosis of bipolar disorder
Behavioral: Analysis of social cognition, memory functioning, and executive functioning processes
Investigation of social cognition, memory functioning, and executive processes using a comprehensive clinical and cognitive assessment
Experimental: Major depressive patients
Patients with a diagnosis of major depressive disorder
Behavioral: Analysis of social cognition, memory functioning, and executive functioning processes
Investigation of social cognition, memory functioning, and executive processes using a comprehensive clinical and cognitive assessment
Experimental: First-degree relatives of bipolar patients
Behavioral: Analysis of social cognition, memory functioning, and executive functioning processes
Investigation of social cognition, memory functioning, and executive processes using a comprehensive clinical and cognitive assessment
Experimental: Bipolar controls
Healthy control participants matched to group 1
Behavioral: Analysis of social cognition, memory functioning, and executive functioning processes
Investigation of social cognition, memory functioning, and executive processes using a comprehensive clinical and cognitive assessment
Experimental: Depressive controls
Healthy control participants matched to group 2
Behavioral: Analysis of social cognition, memory functioning, and executive functioning processes
Investigation of social cognition, memory functioning, and executive processes using a comprehensive clinical and cognitive assessment

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Social cognition: facial emotion recognition
Time Frame: Day 0
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
CHU de Reims

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
EPSM de la Marne

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 7, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 7, 2028

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 7, 2028

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 13, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 13, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 18, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 13, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 11, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • PO24114*

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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