Bipolar Disorder, SchizophreniaTOM-iNCT02834182
fMRI of Theory of Mind in Schizophrenia and Bipolar Disorder
A study testing IRMf, Mini International Neuropsychiatric Interview and Positive And Negative Syndrom Scale in people with Bipolar Disorder, Schizophrenia, run by CHU de Reims at 1 site in France.
Trial summary
Theory of mind (TOM), a main component of social cognition processes, refers to the capacity to infer one's own and other person's mental states. Deficits in social cognition are found in patients with schizophrenia and bipolar disorder. 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, Schizophrenia
- What is being tested?
- IRMf, Mini International Neuropsychiatric Interview and Positive And Negative Syndrom Scale
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteFrance
- Study dates
- Jul 2016to Jun 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 :
- Men or women aged from 18 to 65 years-old, right-handed, with a diagnosis of bipolar -disorder or schizophrenia, according to the DSM-5 criteria
- Native French speaker
- No substantial change in treatment for 2 weeks preceding study enrollment
- Able to provide informed written and verbal consent
- Healthy Controls :
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- Men or women aged from 18 to 65 years-old, right-handed
- Native French speaker
- Able to provide informed written and verbal consent
Who cannot join
- Patients :
- A recent alcohol and/or drug abuse or dependence (in the last six months)
- A significant general medical illness, including neurological disorders or head trauma
- A sensorial impairment uncorrected (visual and/or hearing)
- Contraindication to the use of MRI
- Persons under legal incapacity
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- Persons who are not covered by national health insurance
- Healthy Controls :
- Severe chronic psychiatric disorders including Bipolar disorder and schizophrenia
- Depression diagnostic according to DSM-5
- A personal or first-degree-relative history of bipolar disorder, schizophrenia or schizoaffective disorder according to DSM-5
- A recent alcohol and/or drug abuse or dependence (in the last six months)
- A significant general medical illness, including neurological disorders or head trauma
- A sensorial impairment uncorrected (visual and/or hearing)
- Contraindication to the use of MRI
- People particularly protected by the law
- Persons who are not covered by national health insurance
Trial locations and contacts
1 site in 1 country.
Arthur KALADJIAN contact
France1 site
Chu de Reims
Reims, France, 51092
Arthur KALADJIAN, akaladjian@chu-reims.fr
About this study
Official title: Functional Magnetic Resonance Imaging Study: Theory of Mind Deficits in Schizophrenia and Bipolar Disorder
Theory of mind (TOM), a main component of social cognition processes, refers to the capacity to infer one's own and other person's mental states. Deficits in social cognition are found in patients with schizophrenia and bipolar disorder. The purpose of this study is to compare the neurofunctional profiles of schizophrenic patients, bipolar patients and healthy participants during the performance of a TOM task. Results may help to understand the neural bases of the impairments in social cognition in schizophrenia and bipolar disorder, which may in turn help to propose potential new psychosocial therapeutic approaches in these disorders.
Read the detailed description
Theory of mind (TOM) refer to the cognitive ability to attribute mental states to others, which plays an essential role in social communications and interactions between individuals. In several recent papers, it was shown that TOM is impaired in schizophrenia and bipolar disorder. This impairment strongly affects the quality of life in patients suffering from these disorders. The investigators study aims to explore the neural correlates of TOM in schizophrenic and bipolar patients, in comparison with those of healthy participants. These studies will be conducted on 30 schizophrenic patients, 30 bipolar patients, and 60 healthy participants, matched on age and educational level to each patient group. The investigators expect that the study of combined behavioral (neuropsychological tests) and neuro-anatomical data will allow to understand the pathophysiology of the alteration of social cognition processes in these illnesses.
- Conditions
- Bipolar Disorder, Schizophrenia
- Being tested
- IRMf, Mini International Neuropsychiatric Interview, Positive And Negative Syndrom Scale, Young Mania Rating Scale, Hamilton Depression Scale
- Medical subject headings
- Bipolar Disorder, Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IRMfBehavioural
Mini International Neuropsychiatric InterviewBehavioural
Positive And Negative Syndrom ScaleBehavioural
Young Mania Rating ScaleBehavioural
Hamilton Depression ScaleBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Bipolar Disorder patients and Schizophrenic patients | Experimental | Not described Receives: Behavioral: IRMf; Behavioral: Mini International Neuropsychiatric Interview; Behavioral: Positive And Negative Syndrom Scale; Behavioral: Young Mania Rating Scale; Behavioral: Hamilton Depression Scale |
| Healthy Controls | Active comparator | Not described Receives: Behavioral: IRMf; Behavioral: Mini International Neuropsychiatric Interview; Behavioral: Positive And Negative Syndrom Scale; Behavioral: Young Mania Rating Scale; Behavioral: Hamilton Depression Scale |
What is being measured
The primary outcome is the main question the study is designed to answer.
Neuropsychological test : Mini International Neuropsychiatric Interview (M.I.N.I.)
Measured: Up to 15 days after inclusion
Young Mania Rating Scale
Measured: Up to 15 days after inclusion
Hamilton Depression Scale
Measured: Up to 15 days after inclusion
Scale for the Assessment for Thought, Language and Communication
Measured: Up to 15 days after inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2016 (estimated)
- Study startJul 2016
- Primary completionJun 2019 (estimated)
- Study completionJun 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Bipolar Disorder, SchizophreniaStudies 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
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- CHU de Reims
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02834182
- Sponsor's protocol ID
- PO16049
- Acronym
- TOM-i
- Status last verified
- Jun 2016
- First submitted
- 24 Jun 2016
- Last updated
- 15 Jul 2016
- Results posted
- No
Publications
Henry A, Raucher-Chene D, Obert A, Gobin P, Vucurovic K, Barriere S, Sacre S, Portefaix C, Gierski F, Caillies S, Kaladjian A. Investigation of the neural correlates of mentalizing through the Dynamic Inference Task, a new naturalistic task of social cognition. Neuroimage. 2021 Nov;243:118499. doi: 10.1016/j.neuroimage.2021.118499. Epub 2021 Aug 24.
PubMed 34438254
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Functional Magnetic Resonance Imaging Study: Theory of Mind Deficits in Schizophrenia and Bipolar Disorder
- ClinicalTrials.gov ID
- NCT02834182
- Acronym / sponsor ID
- TOM-i / PO16049
- Conditions
- Bipolar Disorder, Schizophrenia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- CHU de ReimsUniversity, hospital or other
- Study start
- Jul 2016
- Primary completion
- Jun 2019 (estimated)
- Study completion
- Jun 2019 (estimated)
- First posted
- 15 Jul 2016 (estimated)
- 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.
Theory of mind (TOM), a main component of social cognition processes, refers to the capacity to infer one's own and other person's mental states. Deficits in social cognition are found in patients with schizophrenia and bipolar disorder. The purpose of this study is to compare the neurofunctional profiles of schizophrenic patients, bipolar patients and healthy participants during the performance of a TOM task. Results may help to understand the neural bases of the impairments in social cognition in schizophrenia and bipolar disorder, which may in turn help to propose potential new psychosocial therapeutic approaches in these disorders.
Detailed description
Theory of mind (TOM) refer to the cognitive ability to attribute mental states to others, which plays an essential role in social communications and interactions between individuals. In several recent papers, it was shown that TOM is impaired in schizophrenia and bipolar disorder. This impairment strongly affects the quality of life in patients suffering from these disorders. The investigators study aims to explore the neural correlates of TOM in schizophrenic and bipolar patients, in comparison with those of healthy participants. These studies will be conducted on 30 schizophrenic patients, 30 bipolar patients, and 60 healthy participants, matched on age and educational level to each patient group. The investigators expect that the study of combined behavioral (neuropsychological tests) and neuro-anatomical data will allow to understand the pathophysiology of the alteration of social cognition processes in these illnesses.
Study design
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bipolar Disorder patients and Schizophrenic patients | Experimental | Behavioral: IRMf, Behavioral: Mini International Neuropsychiatric Interview, Behavioral: Positive And Negative Syndrom Scale, Behavioral: Young Mania Rating Scale, Behavioral: Hamilton Depression Scale |
| Healthy Controls | Active comparator | Behavioral: IRMf, Behavioral: Mini International Neuropsychiatric Interview, Behavioral: Positive And Negative Syndrom Scale, Behavioral: Young Mania Rating Scale, Behavioral: Hamilton Depression Scale |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Men or women aged from 18 to 65 years-old, right-handed, with a diagnosis of bipolar -disorder or schizophrenia, according to the DSM-5 criteria
- Native French speaker
- No substantial change in treatment for 2 weeks preceding study enrollment
- Able to provide informed written and verbal consent
- Men or women aged from 18 to 65 years-old, right-handed
Key exclusion criteria (17 listed)
- A recent alcohol and/or drug abuse or dependence (in the last six months)
- A significant general medical illness, including neurological disorders or head trauma
- A sensorial impairment uncorrected (visual and/or hearing)
- Contraindication to the use of MRI
- Persons under legal incapacity
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 |
|---|---|---|
| IRMf | Behavioural | Bipolar Disorder patients and Schizophrenic patients, Healthy Controls |
| Mini International Neuropsychiatric Interview | Behavioural | Bipolar Disorder patients and Schizophrenic patients, Healthy Controls |
| Positive And Negative Syndrom Scale | Behavioural | Bipolar Disorder patients and Schizophrenic patients, Healthy Controls |
| Young Mania Rating Scale | Behavioural | Bipolar Disorder patients and Schizophrenic patients, Healthy Controls |
| Hamilton Depression Scale | Behavioural | Bipolar Disorder patients and Schizophrenic patients, Healthy Controls |
Primary outcome
Neuropsychological test : Mini International Neuropsychiatric Interview (M.I.N.I.)
Time frame: Up to 15 days after inclusion
Young Mania Rating Scale
Time frame: Up to 15 days after inclusion
Hamilton Depression Scale
Time frame: Up to 15 days after inclusion
Scale for the Assessment for Thought, Language and Communication
Time frame: Up to 15 days after inclusion
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jul 2016.
- Derived from this study: PubMed 34438254Henry A, Raucher-Chene D, Obert A, Gobin P, Vucurovic K, Barriere S, Sacre S, Portefaix C, Gierski F, Caillies S, Kaladjian A. Investigation of the neural correlates of mentalizing through the Dynamic Inference Task, a new naturalistic task of social cognition. Neuroimage. 2021 Nov;243:118499. doi: 10.1016/j.neuroimage.2021.118499. Epub 2021 Aug 24.
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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. This study is not recruiting at the moment.
Arthur KALADJIAN contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing IRMf, Mini International Neuropsychiatric Interview and Positive And Negative Syndrom Scale in people with Bipolar Disorder, Schizophrenia, 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 9 inclusion and 17 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: status not confirmed, as of the sponsor's last update on 15 Jul 2016. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Arthur KALADJIAN (akaladjian@chu-reims.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Neuropsychological test : Mini International Neuropsychiatric Interview (M.I.N.I.) (time frame: Up to 15 days after inclusion). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02834182, which also lists 1 linked publication.
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 15 Jul 2016.