Understanding the Neurobiological Effects of Oxytocin on Social Trust Deficits in Schizophrenia: A Multimodal Imaging - Genetics Study
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 44
- 试验地点
- 1
- 主要终点
- PET
研究概览
简要总结
22 male patients with schizophrenia and 22 male healthy volunteers will be included in the study. 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 multi-modal imaging sessions. In one scan they will receive intranasal oxytocin and in another scan will receive intranasal saline as control. The order of administration of the medication will be counterbalanced and subjects will be blind to the medication administered. Using the simultaneous PET-MRI scanner, PET and fMRI data will be collected simultaneously. Blood will be collected for analysis of oxytocin receptor gene polymorphism and its potential effect on brain activity.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 主要目的
- Other
- 盲法
- Double (Participant, Investigator)
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
- •Diagnosis of schizophrenia or schizoaffective disorder
- •Males between 18 and 45 years
- •capacity to provide informed consent
排除标准
- •current comorbid axis I diagnosis and no alcohol/substance abuse/dependence in the last 12 months (except nicotine)
- •Contraindication to oxytocin like hypersensitivity, vascular disease, chronic nephritis, epilepsy, asthma
- •Contraindication to MRI like implants/claustrophobia
- •Past history of head injury resulting in loss of consciousness or neurosurgery
- •Concomitant severe medical conditions
- •On treatment with benzodiazepine medications for at least 8 weeks
- •Contraindication to Positron emission tomography
- •Healthy volunteers
- •Inclusion Criteria:
- •Males between 18 and 45 years
- •capacity to provide informed consent
- •Exclusion Criteria:
- •Lifetime diagnosis of psychiatric illness including substance dependence
- •contraindication to oxytocin like hypersensitivity, vascular disease, chronic nephritis, epilepsy, asthma
- •contraindication to MRI like implants/claustrophobia
- •past history of head injury resulting in loss of consciousness or neurosurgery
- •concomitant severe medical conditions
- •on treatment with benzodiazepine medications for at least 8 weeks
- •contraindication to Positron emission tomography
- •Family history of schizophrenia, schizoaffective or schizophreniform disorder in family member
研究组 & 干预措施
Oxytocin
Single-dose oxytocin or placebo will be given intranasally on separate scan days. The order of administration will be counterbalanced
干预措施: Oxytocin (Drug)
Placebo
Single-dose oxytocin or placebo will be given intranasally on separate scan days. The order of administration will be counterbalanced
干预措施: Placebo (Drug)
结局指标
主要结局
PET
时间窗: 90 minues
changes in \[18F\] flumazenil specific binding
fMRI changes
时间窗: 90 minutes
changes in brain functional connectivity
MRS
时间窗: 90 minutes
Changes in brain chemistry measured using MRS
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