NCT01669889已完成不适用
A Multi-center, Non-drug Study to Explore the Relationship Between Exploratory Biomarkers and Functional Dimensions in Individuals With Autistic Disorder or Asperger's Syndrome.
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 38
- 主要终点
- Cognition assessment ratings
研究概览
简要总结
This multi-center, non-drug study will explore the relationship between exploratory biomarkers and functional dimensions in male adult individuals with Autistic Disorder or Asperger's Syndrome and healthy volunteer controls. Subjects will undergo a number of assessments on study visit Day 1.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Individuals with Autistic Disorder or Asperger's Syndrome:
- •Male adults, 18 to 45 years of age inclusive
- •Diagnosis of Autistic Disorder or Asperger's Syndrome as defined by DSM-IV
- •Body mass index (BMI) 18 to 35 kg/m2
- •Availability of a reliable caregiver, able and willing to provide information regarding the individual's behavior and symptoms
- •Healthy controls:
- •Healthy male adults, 18 to 45 years of age inclusive
- •Body mass index (BMI) 18 to 30 kg/m2
排除标准
- •General exclusion criteria:
- •Positive test for drugs of abuse or alcohol
- •Confirmed systolic blood pressure >140 or <90 mmHg, and diastolic blood pressure >90 or <50 mmHg
- •Resting pulse rate >100 or <40 beats per minute
- •Alcohol and/or substance abuse/dependence during the last 12 months
- •Concomitant disease or condition that could interfere with, or treatment of which might interfere with, the conduct of the study, or that would, in the opinion of the investigator, pose an unacceptable risk to the subject in this study
- •Additionally for individuals with Autistic Disorder or Asperger's Syndrome:
- •History of epilepsy/seizure disorder (except simple febrile seizures)
- •Significant disruptive, aggressive or self-injurious, or sexually inappropriate behavior during the last 3 months that in the opinion of the investigator might interfere with the conduct of the study
- •Additionally for healthy controls:
- •Clinically significant abnormalities in laboratory test results
- •History of or current psychiatric, neurological disorder or pervasive developmental disorder
结局指标
主要结局
Cognition assessment ratings
时间窗: approximately 5 months
Behavior assessment ratings
时间窗: approximately 5 months
次要结局
未报告次要终点
研究者
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