A Randomized, Placebo-Controlled Trial of Omega-3 Fatty Acids in the Treatment of Young Children With Autism
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 38
- 试验地点
- 2
- 主要终点
- Change From Baseline in the Pervasive Developmental Disorder-Behavioral Inventory (PDDBI) - Autism Composite Score
研究概览
简要总结
This is a pilot, randomized, placebo-controlled trial of omega-3 fatty acids in autism. Autism, originally described by Kanner in 1943, is among the most severe of neurodevelopmental disorders. It is a Pervasive Developmental Disorder (PDD) affecting social and communicative functions and is also characterized by repetitive behaviors/restricted interests. It is also frequently accompanied by significant aggression, self-injury, irritability and hyperactivity, making care for these individuals an even greater challenge for families or institutional settings. Autism severely impacts the affected individual and family members, causing life-long functional impairment. In this protocol the investigators will use the terms "autism" and "autism spectrum disorder (ASD)" interchangeably to refer to Autistic disorder, Asperger Syndrome and PDD-Not Otherwise Specified (NOS).
详细描述
Currently risperidone is the only medication approved the by Food and Drug Administration (FDA) for this disorder, and specifically for irritability associated with autism, although not all patients with autism respond to risperidone. No pharmacologic treatments have been approved for use in preschool children, although it is clear that early intervention is associated with improved outcomes. Behavioral and educational therapies play a significant role in the management of autistic symptoms. The history of alternative treatments in autism is notable for the exaggerated benefit of a variety of supplements, such as high dose vitamins (e.g. B6, magnesium), and secretin. The current widespread use of alternative/nutritional supplements to patients with autism without scientifically demonstrated efficacy, underscores the necessity for scientifically sound studies to be conducted. Complementary and alternative medical therapies (CAM) are commonly employed by families of autistic children. Recent surveys have estimated the prevalence of such use to be between 30% and 95% (1,2,3). Omega-3 fatty acids were reported to be used in 28.7% of patients (1). However, only two small case series and a very small randomized study have been reported in this population to date. The investigators propose to conduct a randomized controlled trial of omega-3 fatty acids in preschoolers 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
- 2 Years 至 5 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female outpatients 2-5 years of age.
- •Meet Diagnostic and Statistical Manual of Mental Disorders, 4th Edition, Text Revision (DSM-IV) criteria. DSM-IV criteria for an autism spectrum disorder, (Autistic disorder, Asperger syndrome or PDD-NOS) will be established by a clinician with expertise with individuals with ASD based on parent interview, Autism Diagnostic Observation Schedule (ADO) and Autism Diagnostic Interview (ADI-R)
- •If already receiving stable non pharmacologic educational, behavioral, dietary and or/ natural health product interventions during the preceding 3 months prior to Screening, will not electively initiate new or modify ongoing interventions for the duration of the study unless the child's condition is worsening or their turn comes up on the treatment waiting list.
- •Have normal physical examination and laboratory test results at Screening. If abnormal, the finding(s) must be deemed clinically insignificant by the Investigator.
- •The parents must be able to speak and understand English sufficiently to allow for the completion of all study assessments.
排除标准
- •Patients born prior to 35 weeks gestational age.
- •Patients with any primary psychiatric diagnosis other than autism at Screening. We are aware the most primary psychiatric disorders are unlikely to be diagnosed in this age group
- •Patients with a medical history of neurological disease, including, but not limited to, epilepsy/seizure disorder (except simple febrile seizures), movement disorder, tuberous sclerosis, fragile X, and any other known genetic syndromes, or known abnormal MRI/structural lesion of the brain.
- •Patients with a medical condition that might interfere with the conduct of the study, confound interpretation of the study results, or endanger their own well-being. Patients with evidence or history of malignancy or any significant hematological, endocrine, cardiovascular (including any rhythm disorder), respiratory, renal, hepatic, or gastrointestinal disease, or coagulation deficits.
- •Patients taking psychoactive medication(s) (e.g.,stimulants, antidepressants, antipsychotics, antiepileptics, anxiolytics, clonidine).
- •Patients that have been off pharmacotherapy for less than 6 weeks.
- •Patients who are participating in another clinical trial
- •Patients on anticoagulants
- •Patients who know that they will initiate or change nonpharmacologic interventions during the course of the study.
- •Patients unable to tolerate venipuncture procedures for blood sampling.
- •Patients taking Omega-3 supplements who have not discontinued treatment for six weeks prior to entering into the study.
- •Patients who have allergies to any of the ingredients in omega-3 (study product) or the placebo.
结局指标
主要结局
Change From Baseline in the Pervasive Developmental Disorder-Behavioral Inventory (PDDBI) - Autism Composite Score
时间窗: Baseline and 24 Weeks
The PDDBI measures autism symptomology. The autism composite score was used as the primary outcome measure for autism symptom severity. PDDBI Autism Composite Scale Range: Minimum Range = 10 (lower autism symptom severity) Maximum Range = 100 (higher autism symptom severity) The Autism Composite is calculated from the sum of T-scores of the Sensory/Perceptual Approach Behaviours, Ritualisms/Resistance to Change, Social Pragmatic Problems, and Semantic/Pragmatic Problems domains subtracted by the sum of T-scores of the Social Approach Behaviours, and Expressive Language domain then converted into the Autism Composite as a T-score. Mean change between baseline and week 24 is reported. A negative change indicates improvement
Change From Baseline in the Behaviour Assessment System for Children (BASC-2) - Externalizing Problems Composite
时间窗: Baseline and 24 Weeks
The BASC-2 externalizing problems composite measures hyperactivity and aggressive behaviours. Primary Outcome domain: Externalizing Problems composite Externalizing Problems Composite T-Score Range: Minimum Range: 10 (lower externalizing problems) Maximum Range: 120 (higher externalizing problems) The Externalizing Problems composite is computed from the sum of t-scores from the hyperactivity and aggression subscales then converted into the externalizing problems composite t-score. Mean change between baseline and week 24 is reported. A negative change indicates improvement.
次要结局
- Change From Baseline in the Vineland Adaptive Behavioral Scales (VABS) - Adaptive Functioning Composite(Baseline and 24 Weeks)
- Number of Participants Classified as Responders by the Clinical Global Impression - Improvement (CGI-I)(24 weeks)
- Change From Baseline in the Preschool Language Scale (PLS-4) - Total Language(Baseline and 24 Weeks)