EUCTR2013-003067-59-IT进行中（未招募）1 期
A single-center, randomized, double-blind, placebo-controlled, cross-over study of intranasal oxytocin in young adults with Autism Spectrum Disorder - Oxytocin Study
AZIENDA OSPEDALIERA G. BROTZ0 个研究点目标入组 30 人开始时间: 2021年6月8日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 30
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- Male
入选标准
- •1. Diagnosis of Autism Spectrum Disorder.
- •2. Participants aged 18-45 years of age inclusive. 3. Gender: male. 4. IQ = 70 as measured with the WAIS-IV. 5. Signed consent.
- •6. Ability to complete tasks: adequate vision, motor control of a keyboard and mouse, and fluency in Italian.
- •7. Participant must be on a currently stable pharmacologic and/or psychoeducational treatments for at least 3 months and must not have made any treatment changes in the one month period prior to beginning this study.
- •8. Normality or not clinically significant abnormality identified on the medical or laboratory evaluation at the screening visit. A subject with a clinical abnormality or laboratory parameters outside the reference range for this age group may be included only if the Investigator considers that the finding will not introduce additional risk factors and will not interfere with the study procedures.
- •9. Normality or not clinically significant abnormality vital Parameters (BP and HR included) at the screening visit.
- •10. Normal or not clinically significant 12-lead ECG reading at the screening visit.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 30
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1. Gender: female.
- •2. History of traumatic brain injury, epilepsy/seizure disorder (except febrile seizures), or other significant medical or genetic abnormality affecting brain function and motor, sensory or higher cognitive functioning.
- •3. Patients with one or more of the following: HIV, HBV, HCV, recent nose and brain injuries, immunity disorder.
- •4. Cardiac disorders (anamnesis, electrocardiogram, blood pressure and pulse): 50 = heart rate (bpm) = 90, 100 = blood pressure systolic (mmHg) = 140; 60 = blood pressure diastolic (mmHg) = 90.
- •5. Sensory impairments (e.g., significant vision/hearing loss).
- •6. Mental Retardation (e.g., IQ < 70, as measured with the WAIS-IV) or sensory-motor difficulties that would preclude valid use of diagnostic instruments.
- •7. Anamnestic known hypersensitivity to oxytocin or to any of the excipients of Syntocinon Nasal spray. 8. Anamnestic known hypersensitivity to nasal sprays or other drugs.
- •9. Fever or respiratory disease at the time of the baseline visit.
- •10. Judgment by the study physician or the PI that the patient is not suitable for the study due to unforeseeable safety issues.
- •11. Assumption of an investigational product within the following time period prior to the first dosing day in the current study: 6 months.
- •12. Unwillingness or inability to follow the procedures outlined in the protocol.
- •13. Use of inhalation anesthetics, e.g. cyclopropane or halotane within the following time period prior to the screening study day: one month. 14. Use of inhalation antibiotic(s) and inhalation anti-inflammatory drugs within the following time period prior to the screening study day: one month. 15. History of use of drugs of abuse and amphetamines.
- •16. History of regular alcohol consumption within 6 months of the study defined as an average weekly intake of greater than 21 units or an average daily intake of greater than 3 units . One unit is equivalent to a half-pint (220mL) of beer or 1 (25ml) measure of spirits or 1 glass (125ml) of wine.
- •17. Alcohol or nicotine (more than 15 cigarettes per day) abuse or dependence.
- •18. Intake of food, coffee, beverages (except water), nicotine-consumption within the 2 hours before the application of oxytocin/placebo.
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