Intranasal Oxytocin for the Treatment of Autism Spectrum Disorders
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 19
- 试验地点
- 1
- 主要终点
- Number of Participants With Improvement on the Clinical Global Impression-Improvement (CGI-I) Scale
研究概览
简要总结
Autism Spectrum Disorder (ASD) is a developmental disorder characterized by abnormalities in speech and communication, impaired social functioning and repetitive behaviors and restricted interests. Oxytocin (OT) is peptide that is known for its peripheral effects on facilitating uterine contractions and milk let-down; however, studies, mainly with rodents and non-human primates, has found that OT is involved in affiliative behaviors, including sexual behavior, mother-infant and adult-adult pair-bond formation, separation distress, and other aspects of social attachment. Moreover, OT is known to play an important role in repetitive behaviors and stress reactivity. Given that repetitive behaviors and deficits in social interaction are core symptom domains of autism, and that OT is involved in the regulation of repetitive and affiliative behaviors, it is believed that OT may play a role in the etiology of autism. Moreover, preliminary data obtained by Hollander and colleagues suggests that OT may be of value in treating core autism symptoms. Specifically, synthetic oxytocin administered via intravenous infusion to adults with autism spectrum disorders (ASD) produced significant reductions in repetitive behaviors and facilitated social cognition/memory in a double-blind, placebo-controlled cross-over laboratory challenge.
Encouraged by these findings, the primary aim of this study is to investigate the safety and therapeutic efficacy of intranasal OT in treating repetitive behaviors and social functioning/cognitive deficits in adults with ASD. This research embraces a translational approach to develop a novel treatment for core ASD symptoms; given that there are currently no Food and Drug Administration (FDA) approved medication treatments for core ASD symptoms, this research addresses an important unmet need in the field. The goal of this study is to evaluate the safety and efficacy of repeated Intranasal Oxytocin Treatment (INOT)administration in adults with ASD.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male and Female
- •18 to 55 years old
- •Meet Diagnostic and Statistical Manual-IV (DSM-IV), Autism Diagnostic Observation Schedule(ADOS), and Autism Diagnostic Interview-Revised (ADI-R) standards for Autism Spectrum Disorder or Aspergers Syndrome
- •Have a high, normal or near normal Intelligent Quotient
- •Speak and Understand English fluently
排除标准
- •Born prior to 35 weeks gestational age
- •Any primary psychiatric diagnosis other than autism at the time of screening
- •Medical history of neurological disease
- •Medical history of known MRI/structural lesion of the brain
- •Patients who are pregnant
- •With a medical condition that might interfere with the conduct of the study, confound interpretation of study results or endanger their own well being
- •With evidence or history of malignancy or any significant hematological, endocrine, cardiovascular, respiratory, renal, hepatic or gastrointestinal disease
- •Taking psychoactive medications
- •Who plan to initiate or change nonpharmacologic interventions during the study course
- •Who are unable to tolerate venipuncture procedures for blood sampling
研究组 & 干预措施
Oxytocin
干预措施: Intranasal Oxytocin (Drug)
Placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Number of Participants With Improvement on the Clinical Global Impression-Improvement (CGI-I) Scale
时间窗: 6 Weeks
Rating Scale that utilizes direct observation, scales and patient report to inform clinical judgment. A form of CGI that targets social functioning will be used as the primary outcome measure. Semi-structured interview.
次要结局
- Change in Facial Emotion Recognition Based on Diagnostic Analysis of Nonverbal Accuracy - 2 (DANVA-2)(baseline, week 6)
- Change in Obsessive- Compulsive Behavior Based on Yale Brown Obsessive Compulsive Scale (YBOCS)(Baseline, Week 6)
- Change in Repetitive Behavior Based Repetitive Behavior Scale - Revised (RBS-R)(Baseline, week 6)
研究者
Eric Hollander
Clinical Professor
Montefiore Medical Center