NCT04190004已完成不适用
Effect of Intranasal Vasopressin on Cooperative Behavior in Schizophrenia
National Institute of Mental Health and Neuro Sciences, India1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2018年1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
- 30
- 试验地点
- 1
- 主要终点
- Performance in Dictator game
研究概览
简要总结
The study investigates the effect of 40IU of intranasal vasopressin on cooperative behavior in patients with schizophrenia
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 盲法
- Double (Participant, Investigator)
盲法说明
Double
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18-45 years
- •Diagnosed as Schizophrenia or Schizophreniform disorder as per DSM IV TR
- •At least 7 years of formal education
- •MOCA score >24
排除标准
- •Diagnoses of SIADH, Diabetes Insipidus
- •Substance dependence in the past 12 months, excluding nicotine dependence
- •Current comorbid axis 1 psychiatric disorder
- •Hypersensitivity or previous allergy to Vasopressin
- •Serious medical or neurological illness which may interfere with assessment and administration of vasopressin
- •Hypertension
- •Impaired renal functions based on serum creatinine above 1.5
- •Electrolyte imbalance
- •Receiving ECT or has received ECT in the past 8 weeks
- •Clinical history of mental retardation
- •Pregnancy • Lactation
- •Risk of harm to self or others
- •Any significant nasal pathology which may hinder the intranasal absorption of the drug
- •Hearing or visual impairment that significantly affects the comprehension and execution of the study
研究组 & 干预措施
vasopressin
Experimental
All subjects will receive bot 40IU of vasopressin and saline placebo in counterbalanced design
干预措施: Vasopressins (Drug)
Placebo
Placebo Comparator
All subjects will receive bot 40IU of vasopressin and saline placebo in counterbalanced design
干预措施: Placebo (Drug)
结局指标
主要结局
Performance in Dictator game
时间窗: 60 minutes
Amount of money shared in dictator game
Performance in stag hunt game
时间窗: 60 minutes
Security level in stag hunt game
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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