Clinical trial NCT02834182: fMRI of Theory of Mind in Schizophrenia and Bipolar Disorder
Official title: Functional Magnetic Resonance Imaging Study: Theory of Mind Deficits in Schizophrenia and Bipolar Disorder
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Bipolar Disorder, Schizophrenia
Lead sponsor: CHU de Reims
Sponsor class: OTHER
First posted: 2016-07-15
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL

Brief 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. 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.

Eligibility criteria: 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

Primary outcomes:
measure: Neuropsychological test : Mini International Neuropsychiatric Interview (M.I.N.I.)
timeFrame: Up to 15 days after inclusion
measure: Young Mania Rating Scale
timeFrame: Up to 15 days after inclusion
measure: Hamilton Depression Scale
timeFrame: Up to 15 days after inclusion
measure: Scale for the Assessment for Thought, Language and Communication
timeFrame: Up to 15 days after inclusion
Secondary outcomes:
Other outcomes:
Locations:
city: Reims
country: France
facility: Chu de Reims
Study officials:
References:
citation: 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.