NCT04158167已完成不适用
Neurobiological Effects of Oxytocin on Metacognitive Deficits in Schizophrenia: A Pharmacological - Imaging Genetics Study
National Institute of Mental Health and Neuro Sciences, India1 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2013年9月1日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- fMRI changes with oxytocin
研究概览
简要总结
To investigate whether 24IU oxytocin can result in changes in functional brain connectivity in patients with schizophrenia and healthy individuals using functional magnetic resonance imaging (fMRI). The study will also examine the effect of oxytocin receptor gene polymorphism on the functional connectivity
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- •Schizophrenia subjects:
- •Inclusion criteria 1) Males between 18 and 50 years 2) Diagnosis of DSM-IV schizophrenia, schizoaffective or schizophreniform disorder 3) capacity to provide informed consent, as evaluated by the MacArthur Competence Assessment Tool for Clinical Research Exclusion criteria
- •General impairment in intellectual functioning
- •History of alcohol or substance dependence in the last 12 months (with the exception of nicotine)
- •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 50 years
- •Capacity to provide informed consent Exclusion criteria
- •Life-time diagnosis of psychiatric illnesses including substance abuse 2) General impairment in intellectual functioning 3) Past history of head injury resulting in loss of consciousness or neurosurgery 4) Concomitant severe medical or neurological conditions 5) Metal implants or paramagnetic objects or claustrophobia 6) Family history of schizophrenia, schizoaffective or schizophreniform disorder in family member (sibling, parent or offspring) 7) Contraindication to oxytocin like hypersensitivity, vascular disease, chronic nephritis, epilepsy, asthma.
研究组 & 干预措施
oxytocin
Other
All subjects will receive both oxytocin and placebo in a counterbalanced design
干预措施: oxytocin (Drug)
结局指标
主要结局
fMRI changes with oxytocin
时间窗: Upto 90 minutes after administration
changes in functional brain connectivity
次要结局
未报告次要终点
研究者
Dr Naren P Rao
Additional Professor
National Institute of Mental Health and Neuro Sciences, India
研究点 (1)
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