Neurobiological Effects of Oxytocin on Social Decision Making in Schizophrenia: A Pharmacological MRI Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 55
- 主要终点
- fMRI changes with oxytocin while performing ultimatum game and at rest
研究概览
简要总结
schizophrenia patients and healthy volunteers will be included. Subjects who meet the inclusion and exclusion criteria for the study will be recruited. After completion of clinical assessments and neuropsychological assessments, all subjects will undergo two fMRI scans. In one scan subjects will receive a single dose of intranasal oxytocin and in another scan, they will receive intranasal saline. The order of administration of oxytocin or saline will be counterbalanced so that they are not administered in the same order to all subjects. Subjects will be blind to the drug administered.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Males between 18 and 45 years with at least 7 years of education
- •The DSM-IV diagnosis of Schizophrenia or schizoaffective or schizophreniform disorder
- •capacity to provide informed consent
排除标准
- •Current comorbid DSM-IV axis I diagnosis
- •General impaired intellectual functioning
- •history of alcohol or substance abuse or dependence in the last 12 months
- •contraindication to Oxytocin like hypersensitivity, vascular disease, chronic nephritis, epilepsy, asthma
- •past history of head injury resulting in loss of consciousness or neurosurgery
- •concomitant severe medical conditions
- •metal implants or paramagnetic objects within the body or claustrophobia which may interfere with the MRI.
- •Healthy volunteers:
- •Inclusion Criteria:
- •Males between 18 and 45 years with at-least 7 years education
- •Capacity to provide informed consent
- •absence of past or present psychiatric illnesses including substance abuse/dependence
- •Exclusion criteria:
- •General impaired intellectual functioning
- •contraindication to Oxytocin like hypersensitivity, vascular disease, chronic nephritis, epilepsy, asthma
- •past history of head injury resulting in loss of consciousness or neurosurgery
- •concomitant severe medical conditions
- •metal implants or paramagnetic objects within the body or claustrophobia which may interfere with the MRI.
- •Family history of schizophrenia or schizoaffective or schizophreniform disorder in a first-degree relative
研究组 & 干预措施
oxytocin
Single-dose intranasal oxytocin or intranasal placebo administered in counterbalanced order
干预措施: Oxytocin nasal spray (Drug)
Placebo
Single-dose intranasal oxytocin or intranasal placebo administered in counterbalanced order
干预措施: Placebo (Drug)
结局指标
主要结局
fMRI changes with oxytocin while performing ultimatum game and at rest
时间窗: 90 minutes
Changes in brain activity and functional connectivity
次要结局
未报告次要终点
研究者
Dr Naren P Rao
Additional Professor of Psychiatry
National Institute of Mental Health and Neuro Sciences, India