Phase II Study of Oxytocin in Autism to Improve Reciprocal Social Behaviors
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 290
- 试验地点
- 7
- 主要终点
- Change in Aberrant Behavior Checklist-Modified Social Withdrawal Subscale ABC-mSW, a Measure of Social Reciprocity
研究概览
简要总结
The purpose of this research study is to learn about the effects of supplemental intranasal oxytocin as a treatment for improving social difficulties in children and adolescents with autism. This study will also provide additional information about the safety and tolerability of intranasal oxytocin. Investigators expect oxytocin will increase social motivation, improving daily living skills and quality of life.
详细描述
There is a tremendous unmet need for accessible treatments that address core symptoms of ASD and are safe for sustained use. The Study of Oxytocin in ASD to improve Reciprocal Social Behaviors or (SOARS-B) will test a very promising potential treatment-intranasal oxytocin-for ASD's fundamental social communication deficits in a large, group of verbal and nonverbal children. SOARS-B will also provide information about the regulation of DNA methylation and transcription of the oxytocin receptor gene (OXTR), as well as other genes relevant to oxytocin's CNS activity, as a function of time and in response to oxytocin treatment. These data will fill a key gap in our understanding of oxytocin's role in ASD and its ability to alter epigenetic modifications of the OXTR.
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)
盲法说明
Quadruple
入排标准
- 年龄范围
- 3 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Be between the ages of 3 years 0 months and 17 years 11 months at the time of randomization
- •Be diagnosed by clinician experienced in assessment of ASD with autistic disorder, Asperger's syndrome, or PDD-NOS using DSM-V-TR criteria
- •Must have clinical diagnosis of ASD confirmed using the Autism Diagnostic Observation Scale (ADOS, Lord et al., 2001)
- •Must have clinical diagnosis of ASD confirmed using the Autism Diagnostic Interview-Revised (ADI-R, Rutter, 2003). ASD criteria proposed by Risi (2006). Specifically, subject must be within 1 point of autism criteria on both social and communication domains of the ADI or meet autism criteria in one of these ADI domains and come within 2 points of autism criteria in the other
- •Have a guardian who is able to provide informed consent
- •If cognitively able, subject must be able to provide informed assent/consent
排除标准
- •Have a known diagnosis of Rett Syndrome or Childhood Disintegrative Disorder, or have marked sensory impairment such as deafness or blindness
- •Have active cardiovascular disease or renal disease that is not controlled by medication
- •Subjects who are pregnant, lactating, or who refuse to practice contraception if sexually active
- •Subjects who have had changes in allied health therapies, behavioral or educational interventions within the two months prior to randomization other than those associated with school holidays
- •Subjects who have had changes in psychiatric medications within 4 weeks of randomization
- •Subjects who have had previous chronic treatment with oxytocin
- •Subjects who have caretakers who are unable to speak English, be consistently present at visits to report on symptoms, or are otherwise judged as unable to comply with the protocol by the data collection site team
- •Subjects with active seizures within the 6 months preceding screening or baseline -added part way through study in response to subject death.
研究组 & 干预措施
DB Placebo Nasal Spray
Placebo treatment during weeks 0-24 double blind phase
干预措施: Double blind phase Placebo Nasal Spray (Drug)
DB Oxytocin Nasal Spray
DB Oxytocin- quadruply masked treatment with intranasal oxytocin during weeks 0-24 of study during double blind phase of study
干预措施: double Blind Oxytocin Nasal Spray (Drug)
open label intranasal oxytocin
non masked treatment with intranasal oxytocin from weeks 24-48 in those participants who completed first 24 weeks of double blind treatment
干预措施: Open Label intranasal oxytocin (Drug)
结局指标
主要结局
Change in Aberrant Behavior Checklist-Modified Social Withdrawal Subscale ABC-mSW, a Measure of Social Reciprocity
时间窗: Least mean squares for Open Label: Change between weeks 24-48
The ABC-mSW is described above and involves 13 items reflecting lack of reciprocal interaction. Each item is scored from 0 (never shows behavior) to 3 (behavior is a major problem). The range is 0-39. Higher scores indicate worse reciprocal social functioning.
次要结局
- Change in Sociability Factor (SF)(Double-blind phase: change in least means squares between week 0 & 24.)
- Change in Social Responsiveness Scale-2 (SRS-2) Social Motivation Subscale Score(Double-blind phase: baseline, weeks 12, 24)
- Change in Stanford Binet-5th Edition (SB-5) IQ Score(Double-blind phase: baseline to week 24)
研究者
Linmarie Sikich
Associate professor
Duke University