Bipolar Disorder and Major Depressive DisorderCOMETNCT06740331
Social Cognition, Memory, and Executive Functions in Bipolar Disorder and Major Depressive Disorder
A study testing Analysis of social cognition, memory functioning, and executive functioning processes in people with Bipolar Disorder and Major Depressive Disorder, run by CHU de Reims at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Bipolar Disorder and Major Depressive Disorder
- What is being tested?
- Analysis of social cognition, memory functioning, and executive functioning processes
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- 1 siteFrance
- Study dates
- 7 Jan 2025to 7 Feb 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
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- 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
- 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
Who cannot join
- 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
- 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
Show all 14Show fewer
- 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
- 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)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Chu Reims
Reims, 51092
Damien JOLLY, 326788472 ext. 33, djolly@chu-reims.fr
About this study
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.
Read more
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.
Read the 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.
- Being tested
- Analysis of social cognition, memory functioning, and executive functioning processes
- Keywords
- Bipolar disorder, major depressive disorder, high-risk individuals, social cognition, executive functions, memory functions
- Medical subject headings
- Bipolar Disorder, Depressive Disorder, Major
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Analysis of social cognition, memory functioning, and executive functioning processesBehavioural
Investigation of social cognition, memory functioning, and executive processes using a comprehensive clinical and cognitive assessment
| Study group | Role | What they receive |
|---|---|---|
| Bipolar patients | Experimental | Patients with a diagnosis of bipolar disorder Receives: Behavioral: Analysis of social cognition, memory functioning, and executive functioning processes |
| Major depressive patients | Experimental | Patients with a diagnosis of major depressive disorder Receives: Behavioral: Analysis of social cognition, memory functioning, and executive functioning processes |
| First-degree relatives of bipolar patients | Experimental | First-degree relatives of bipolar patients Receives: Behavioral: Analysis of social cognition, memory functioning, and executive functioning processes |
| Bipolar controls | Experimental | Healthy control participants matched to group 1 Receives: Behavioral: Analysis of social cognition, memory functioning, and executive functioning processes |
| Depressive controls | Experimental | Healthy control participants matched to group 2 Receives: Behavioral: Analysis of social cognition, memory functioning, and executive functioning processes |
| First-degree controls | Experimental | Healthy control participants matched to group 3 Receives: Behavioral: Analysis of social cognition, memory functioning, and executive functioning processes |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Day 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2024
- Study start7 Jan 2025
- Primary completion7 Jan 2028 (estimated)
- Study completion7 Feb 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bipolar Disorder and Major Depressive DisorderStudies of the same condition, open and under way.
- More trials run by CHU de ReimsThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- participants are assigned to one of two or more groups in parallel for the duration of the study
- Masking
- None (open label)
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- CHU de Reims
- Sponsor type
- University, hospital or other
- Collaborators
- Public Mental Health Institution of the Marne
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06740331
- Sponsor's protocol ID
- PO24114*
- Acronym
- COMET
- Status last verified
- Mar 2026
- First submitted
- 13 Dec 2024
- Last updated
- 13 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Social Cognition, Memory, and Executive Functions in Bipolar Disorder and Major Depressive Disorder
- ClinicalTrials.gov ID
- NCT06740331
- Acronym / sponsor ID
- COMET / PO24114*
- Keywords
- Bipolar disorder, major depressive disorder, high-risk individuals, social cognition, executive functions, memory functions
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- CHU de ReimsUniversity, hospital or other
- Collaborators
- Public Mental Health Institution of the Marne
- Study start
- 7 Jan 2025 (actual)
- Primary completion
- 7 Jan 2028 (estimated)
- Study completion
- 7 Feb 2028 (estimated)
- First posted
- 18 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 6
- Model description
- participants are assigned to one of two or more groups in parallel for the duration of the study
| Arm | Type | Receives |
|---|---|---|
| Bipolar patients | Experimental | Behavioral: Analysis of social cognition, memory functioning, and executive functioning processesPatients with a diagnosis of bipolar disorder |
| Major depressive patients | Experimental | Behavioral: Analysis of social cognition, memory functioning, and executive functioning processesPatients with a diagnosis of major depressive disorder |
| First-degree relatives of bipolar patients | Experimental | Behavioral: Analysis of social cognition, memory functioning, and executive functioning processesFirst-degree relatives of bipolar patients |
| Bipolar controls | Experimental | Behavioral: Analysis of social cognition, memory functioning, and executive functioning processesHealthy control participants matched to group 1 |
| Depressive controls | Experimental | Behavioral: Analysis of social cognition, memory functioning, and executive functioning processesHealthy control participants matched to group 2 |
| First-degree controls | Experimental | Behavioral: Analysis of social cognition, memory functioning, and executive functioning processesHealthy control participants matched to group 3 |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- 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
Key exclusion criteria (14 listed)
- 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
- A diagnosis of schizophrenia or of bipolar disorder or of depressive disorder according to DSM-5 criteria
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Analysis of social cognition, memory functioning, and executive functioning processesInvestigation of social cognition, memory functioning, and executive processes using a comprehensive clinical and cognitive assessment | Behavioural | Bipolar controls, Bipolar patients, Depressive controls, First-degree controls, First-degree relatives of bipolar patients, Major depressive patients |
Primary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Analysis of social cognition, memory functioning, and executive functioning processes in people with Bipolar Disorder and Major Depressive Disorder, run by CHU de Reims at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 13 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Arthur KALADJIAN (03 26 78 70 45 ext. 0033, kaladjiana@epsm-marne.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Social cognition: facial emotion recognition (time frame: Day 0). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Mar 2026.