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

July 12, 2016 updated by: CHU de Reims

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

120

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Reims, France, 51092
        • CHU de Reims

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Neuropsychological test : Mini International Neuropsychiatric Interview (M.I.N.I.)
Time Frame: Up to 15 days after inclusion
Up to 15 days after inclusion
Young Mania Rating Scale
Time Frame: Up to 15 days after inclusion
Up to 15 days after inclusion
Hamilton Depression Scale
Time Frame: Up to 15 days after inclusion
Up to 15 days after inclusion
Scale for the Assessment for Thought, Language and Communication
Time Frame: Up to 15 days after inclusion
Up to 15 days after inclusion

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

CHU de Reims

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2016

Primary Completion (Anticipated)

June 1, 2019

Study Completion (Anticipated)

June 1, 2019

Study Registration Dates

First Submitted

June 24, 2016

First Submitted That Met QC Criteria

July 12, 2016

First Posted (Estimate)

July 15, 2016

Study Record Updates

Last Update Posted (Estimate)

July 15, 2016

Last Update Submitted That Met QC Criteria

July 12, 2016

Last Verified

June 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PO16049

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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