Bipolar Disorder, Schizophrenia Clinical Trial
— TOM-iOfficial title:
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.
| Status | Not yet recruiting |
| Enrollment | 120 |
| Est. completion date | June 2019 |
| Est. primary completion date | June 2019 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | Both |
| Age group | 18 Years to 65 Years |
| Eligibility |
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 |
Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label
| Country | Name | City | State |
|---|---|---|---|
| France | Chu de Reims | Reims |
| Lead Sponsor | Collaborator |
|---|---|
| CHU de Reims |
France,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Neuropsychological test : Mini International Neuropsychiatric Interview (M.I.N.I.) | Up to 15 days after inclusion | No | |
| Primary | Young Mania Rating Scale | Up to 15 days after inclusion | No | |
| Primary | Hamilton Depression Scale | Up to 15 days after inclusion | No | |
| Primary | Scale for the Assessment for Thought, Language and Communication | Up to 15 days after inclusion | No |