Functional Magnetic Resonance Imaging Study: Theory of Mind Deficits in Schizophrenia and Bipolar Disorder
试验速览
- 阶段
- 不适用
- 发起方
- CHU de Reims
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Hamilton Depression Scale
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Bipolar Disorder patients and Schizophrenic patients
干预措施: Hamilton Depression Scale (Behavioral)
Bipolar Disorder patients and Schizophrenic patients
干预措施: Young Mania Rating Scale (Behavioral)
Bipolar Disorder patients and Schizophrenic patients
干预措施: IRMf (Behavioral)
Bipolar Disorder patients and Schizophrenic patients
干预措施: Mini International Neuropsychiatric Interview (Behavioral)
Bipolar Disorder patients and Schizophrenic patients
干预措施: Positive And Negative Syndrom Scale (Behavioral)
Healthy Controls
干预措施: IRMf (Behavioral)
Healthy Controls
干预措施: Mini International Neuropsychiatric Interview (Behavioral)
Healthy Controls
干预措施: Positive And Negative Syndrom Scale (Behavioral)
Healthy Controls
干预措施: Young Mania Rating Scale (Behavioral)
Healthy Controls
干预措施: Hamilton Depression Scale (Behavioral)
结局指标
主要结局
Hamilton Depression Scale
时间窗: Up to 15 days after inclusion
Neuropsychological test : Mini International Neuropsychiatric Interview (M.I.N.I.)
时间窗: Up to 15 days after inclusion
Young Mania Rating Scale
时间窗: Up to 15 days after inclusion
Scale for the Assessment for Thought, Language and Communication
时间窗: Up to 15 days after inclusion
次要结局
未报告次要终点