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fMRI of Theory of Mind in Schizophrenia and Bipolar Disorder

Functional Magnetic Resonance Imaging Study: Theory of Mind Deficits in Schizophrenia and Bipolar Disorder

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02834182
Acronym
TOM-i
Enrollment
120
Registered
2016-07-15
Start date
2016-07-31
Completion date
2019-06-30
Last updated
2016-07-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bipolar Disorder, Schizophrenia

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.

Interventions

BEHAVIORALIRMf
BEHAVIORALPositive And Negative Syndrom Scale
BEHAVIORALHamilton Depression Scale

Sponsors

CHU de Reims
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frame
Neuropsychological test : Mini International Neuropsychiatric Interview (M.I.N.I.)Up to 15 days after inclusion
Young Mania Rating ScaleUp to 15 days after inclusion
Hamilton Depression ScaleUp to 15 days after inclusion
Scale for the Assessment for Thought, Language and CommunicationUp to 15 days after inclusion

Countries

France

Contacts

Primary ContactArthur KALADJIAN
akaladjian@chu-reims.fr

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026