fMRI of Theory of Mind in Schizophrenia and Bipolar Disorder

NCT ID: NCT02834182

Last Updated: 2016-07-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-07-31

Study Completion Date

2019-06-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Bipolar Disorder, Schizophrenia

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Bipolar Disorder patients and Schizophrenic patients

Group Type EXPERIMENTAL

IRMf

Intervention Type BEHAVIORAL

Mini International Neuropsychiatric Interview

Intervention Type BEHAVIORAL

Positive And Negative Syndrom Scale

Intervention Type BEHAVIORAL

Young Mania Rating Scale

Intervention Type BEHAVIORAL

Hamilton Depression Scale

Intervention Type BEHAVIORAL

Healthy Controls

Group Type ACTIVE_COMPARATOR

IRMf

Intervention Type BEHAVIORAL

Mini International Neuropsychiatric Interview

Intervention Type BEHAVIORAL

Positive And Negative Syndrom Scale

Intervention Type BEHAVIORAL

Young Mania Rating Scale

Intervention Type BEHAVIORAL

Hamilton Depression Scale

Intervention Type BEHAVIORAL

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

IRMf

Intervention Type BEHAVIORAL

Mini International Neuropsychiatric Interview

Intervention Type BEHAVIORAL

Positive And Negative Syndrom Scale

Intervention Type BEHAVIORAL

Young Mania Rating Scale

Intervention Type BEHAVIORAL

Hamilton Depression Scale

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

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 :

* Men or women aged from 18 to 65 years-old, right-handed
* Native French speaker
* Able to provide informed written and verbal consent

Exclusion Criteria

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
* 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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

CHU de Reims

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Chu de Reims

Reims, France, France

Site Status

Countries

Review the countries where the study has at least one active or historical site.

France

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Arthur KALADJIAN

Role: CONTACT

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Arthur KALADJIAN

Role: primary

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type DERIVED
PMID: 34438254 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

PO16049

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.