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fMRI of Theory of Mind in Schizophrenia and Bipolar Disorder (TOM-i)

C

CHU de Reims

Status

Unknown

Conditions

Bipolar Disorder, Schizophrenia

Treatments

Behavioral: Hamilton Depression Scale
Behavioral: Young Mania Rating Scale
Behavioral: Positive And Negative Syndrom Scale
Behavioral: Mini International Neuropsychiatric Interview
Behavioral: IRMf

Study type

Interventional

Funder types

Other

Identifiers

NCT02834182
PO16049

Details and patient eligibility

About

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.

Full 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.

Enrollment

120 estimated patients

Sex

All

Ages

18 to 65 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

120 participants in 2 patient groups

Bipolar Disorder patients and Schizophrenic patients
Experimental group
Treatment:
Behavioral: Hamilton Depression Scale
Behavioral: Young Mania Rating Scale
Behavioral: Positive And Negative Syndrom Scale
Behavioral: IRMf
Behavioral: Mini International Neuropsychiatric Interview
Healthy Controls
Active Comparator group
Treatment:
Behavioral: Hamilton Depression Scale
Behavioral: Young Mania Rating Scale
Behavioral: Positive And Negative Syndrom Scale
Behavioral: IRMf
Behavioral: Mini International Neuropsychiatric Interview

Trial contacts and locations

1

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Central trial contact

Arthur KALADJIAN

Data sourced from clinicaltrials.gov

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