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临床试验/NCT01337700
NCT01337700已完成4 期

Milnacipran in Autism and the Functional Locus Coeruleus and Noradrenergic Model of Autism

Montefiore Medical Center1 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2011年2月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
已完成
入组人数
10
试验地点
1
主要终点
Change in Score on Conners Adults Attention Deficit Hyperactivity Disorder (ADHD) Rating Scale

研究概览

简要总结

Autism Spectrum Disorders (ASD) include Autistic disorder, Asperger's syndrome and Pervasive Developmental Disorder Not Otherwise Specified (PDD-NOS). These are developmental disorders beginning prior to three years of age. Recent Centers for Disease Control (CDC) estimates suggest that ASD affects up to 1 in 100 individuals and up to 1 in 50 boys. There are very substantial costs associated with caring for patients with ASD, and ASD has the highest Caregiver Burden Scores of any condition. There are three core symptom domains of ASD, including social deficits, repetitive behaviors and language deficits. Patients can also have associated symptoms of attentional deficits, disruptive behaviors and intellectual disability. There is currently no Food and Drug administration (FDA) approved treatment for the core symptoms of autism, but risperidone and aripiprazole have FDA approval for disruptive behaviors associated with autism.

This is a 12 week randomized double blind placebo controlled trial of Milnacipran in adults with ASD or Aspergers Syndrome. Milnacipran is said to play a role in the activation and normalization of the locus coeruleus-noradrenergic system, of which is hypothesized to play a role in behavior adaptations and performance.

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 50 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Male and Female patients
  • Aged 18-50 years
  • Diagnosis of Autism Spectrum Disorder
  • intelligence quotient greater than 70

排除标准

  • Pregnant subjects
  • Patients deemed by comprehensive psychiatric interview to have a significant risk of suicide

研究组 & 干预措施

Milnacipran

Experimental

干预措施: Milnacipran (Drug)

Placebo

Placebo Comparator

干预措施: Placebo (Drug)

结局指标

主要结局

Change in Score on Conners Adults Attention Deficit Hyperactivity Disorder (ADHD) Rating Scale

时间窗: Baseline and Week 12 scores

Change will be measured in each subject's score on the Conners Adults Attention Deficit Hyperactivity Disorder (ADHD) Rating Scale from baseline through study end (week 12).Higher values represent a worse outcome. The raw scores are converted to T-scores for each scale and sub-scale which are then compared against the mean. Higher values represent a worse outcome. A T-score of 50 is the mean of a relevant reference population. A T-score above 65 indicates a moderate to severe problem. For example, Row 1 is the mean of baseline T-scores for the Inattention/ Memory subscale and Row 2 is the mean of week 12 T-scores for the Inattention/ Memory subscale. The difference between these two means is used to measure the change from baseline through week 12 for both the groups.

Change in Hyperactivity as Measured by Aberrant Behavior Checklist - Hyperactivity Scale

时间窗: Baseline to Endpoint - 12 weeks

The Aberrant Behavior Checklist is an informant-based questionnaire consisting of 58 items subdivided amongst 5 scales: irritability, lethargy and social withdrawal, stereotypic behavior, hyperactivity/non-compliance, and inappropriate speech \[34\]. A score for each item ranges from 0 indicating "no problem" to 3 indicating "severe problem". Scale scores are calculated by summing the items within that scale. Higher scores indicate greater impairment.Reported Data is for change in ABC-H from baseline to endpoint (week 0 to week 12).This data is specifically looking at the hyperactivity scale which is 16 items with each item ranging from 0-3 making total scores 0-48.

次要结局

  • Change in Autism Severity Levels Based on the Clinical Global Impressions Scale(screening, baseline, weeks 2,4,6,8,10,12)
  • Change in Repetitive Behaviors Using YBOCS-Compulsion and Rigidity Subscale(baseline, weeks 2,4,6,8,10,12)
  • Change in Diagnostic Analysis of Nonverbal Activity-2 ADULT FACIAL EXPRESSIONS: (DANVA2-AF)(baseline, weeks 2,4,6,8,10,12)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Eric Hollander

Clinical Professor

Montefiore Medical Center

研究点 (1)

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