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Status unknownNCT02834182TOM-iUpdated Jul 15, 2016

fMRI of Theory of Mind in Schizophrenia and Bipolar Disorder

An interventional study of IRMf and Mini International Neuropsychiatric Interview in Bipolar Disorder, Schizophrenia, sponsored by CHU de Reims. Status unknown at 1 site in France. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2016-07-15.

Sponsored by CHU de Reims · Not applicable and Interventional

The sponsor has not verified this record recently (last verified Jun 2016), so the status shown — last known as Not yet recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
120
Allocation
Non-randomized
Ages
18 Years to 65 Years
Sex
All
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Study 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.

Read the 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.

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Conditions studied

  • Bipolar Disorder, Schizophrenia
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In context

Schizophrenia

3,471 studies on the registry are indexed under Schizophrenia; 472 are open to participants now.

This study's planned enrollment of 120 is above the median of 70 across 2,872 interventional studies indexed under Schizophrenia.

Browse Schizophrenia studies →

Lead sponsor

CHU de Reims is the lead sponsor of 267 studies on the registry; 50 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts 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

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
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Study design

Phase
Not applicable
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
120 participants (estimated)

Study arms

  • 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

  • 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

Interventions

  • BehavioralIRMf
  • BehavioralMini International Neuropsychiatric Interview
  • BehavioralPositive And Negative Syndrom Scale
  • BehavioralYoung Mania Rating Scale
  • BehavioralHamilton Depression Scale
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What researchers measure

Primary outcomes

  1. Neuropsychological test : Mini International Neuropsychiatric Interview (M.I.N.I.)

    Time frame: Up to 15 days after inclusion

  2. Young Mania Rating Scale

    Time frame: Up to 15 days after inclusion

  3. Hamilton Depression Scale

    Time frame: Up to 15 days after inclusion

  4. Scale for the Assessment for Thought, Language and Communication

    Time frame: Up to 15 days after inclusion

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Study locations

1 site
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References and documents

Publications

  • 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. PubMed 34438254 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 15, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02834182
Lead sponsor
CHU de Reims
Responsible party
Sponsor
First posted
Jul 15, 2016
Start date
Jul 2016
Primary completion
Jun 2019 (estimated)
Completion
Jun 2019 (estimated)
Last update
Jul 15, 2016

Study contacts

Arthur KALADJIAN
Contact
akaladjian@chu-reims.fr
View the source record on ClinicalTrials.gov ↗

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This study is status unknown, as verified in Jun 2016. You cannot join it, but the record below documents what was studied.

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