fMRI of Theory of Mind in Schizophrenia and Bipolar Disorder

NCT02834182 | Unknown

• 1 other identifier: PO16049
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Bipolar Disorder, Schizophrenia

Outcome Measures

Primary Outcomes (4)

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

  Up to 15 days after inclusion

• Young Mania Rating Scale

  Up to 15 days after inclusion

• Hamilton Depression Scale

  Up to 15 days after inclusion

• Scale for the Assessment for Thought, Language and Communication

  Up to 15 days after inclusion

Study Arms (2)

Bipolar Disorder patients and Schizophrenic patients

EXPERIMENTAL

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

Healthy Controls

ACTIVE COMPARATOR

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

Interventions

IRMf BEHAVIORAL

Bipolar Disorder patients and Schizophrenic patients; Healthy Controls

Mini International Neuropsychiatric Interview BEHAVIORAL

Bipolar Disorder patients and Schizophrenic patients; Healthy Controls

Positive And Negative Syndrom Scale BEHAVIORAL

Bipolar Disorder patients and Schizophrenic patients; Healthy Controls

Young Mania Rating Scale BEHAVIORAL

Bipolar Disorder patients and Schizophrenic patients; Healthy Controls

Hamilton Depression Scale BEHAVIORAL

Bipolar Disorder patients and Schizophrenic patients; Healthy Controls

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• CHU de Reims: lead

Study Sites (1)

Chu de Reims

Reims, France, 51092, France

Location

Related Publications (1)

• 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.

  PMID: 34438254 DERIVED

MeSH Terms

Conditions

Bipolar Disorder; Schizophrenia

Interventions

Psychiatric Status Rating Scales; Gene Expression

Condition Hierarchy (Ancestors)

Bipolar and Related Disorders; Mood Disorders; Mental Disorders; Schizophrenia Spectrum and Other Psychotic Disorders

Intervention Hierarchy (Ancestors)

Neuropsychological Tests; Psychological Tests; Behavioral Disciplines and Activities; Genetic Phenomena

Central Study Contacts

Arthur KALADJIAN

CONTACT

akaladjian@chu-reims.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 24, 2016
• First Posted: July 15, 2016
• Study Start: July 1, 2016
• Primary Completion: June 1, 2019
• Study Completion: June 1, 2019
• Last Updated: July 15, 2016

Record last verified: 2016-06

Locations

FR (1)