An Open-Label Clinical Trial Conducted Via Telepsychiatry of Complementary and Alternative Treatments (Omega-3 Fatty Acids and Inositol vs. N-acetylcysteine) for the Management of Emotional Dysregulation in Youth With Non-verbal Learning Disability (NVLD) and/or Autism Spectrum Disorders (ASD)
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 54
- 试验地点
- 1
- 主要终点
- Mean Change in the Parent-Young Mania Rating Scale (P-YMRS) Score
研究概览
简要总结
This study consists of a 6-week, open-label, randomized clinical trial study to compare efficacy and tolerability of the natural treatments omega-3 fatty acids, inositol, and N-acetylcysteine (NAC) in the treatment of mood dysregulation in children and adolescents with non-verbal learning disability (NVLD) or Autism Spectrum Disorder (ASD). Subjects will include youth ages 5-17 years with a non-verbal learning disability (NVLD) or autism spectrum disorder (ASD) and current symptoms of emotional dysregulation.
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
- None
入排标准
- 年龄范围
- 5 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •A previous established diagnosis of non-verbal learning disability (NVLD) or DSM-V Autism Spectrum Disorder and/ or combined T-scores on the Child Behavior Checklist > 195 on the Withdrawn + Social Problems + Thought Problems subscales.
- •Current symptoms of emotional dysregulation as indicated by combined T-scores on the Child Behavior Checklist > 180 on the Anxiety/Depression + Aggression + Attention subscales.
- •Subjects and their caregivers must be English-speaking and have a level of understanding sufficient to communicate intelligently with the investigator and study coordinator, and to cooperate with all tests and examinations required by the protocol.
- •Subjects and their caregivers must be willing and able to comply with all study procedures.
- •Each subject and his/her authorized legal representative must understand the nature of the study. The subject's authorized legal representative must sign an informed consent document and the subject must sign an informed assent document.
- •Subject must be able to swallow pills.
- •Subject must have access to a computer with a camera, speaker, microphone, and internet connection.
排除标准
- •Investigator and his/her immediate family; defined as the investigator's spouse, parent, child, grandparent, or grandchild.
- •Serious or unstable illness including hepatic, renal, gastroenterological, respiratory, cardiovascular (including ischemic heart disease), endocrinologic, neurologic, immunologic, or hematologic disease.
- •History of bleeding diathesis, including those with von Willebrand disease.
- •Uncorrected hypothyroidism or hyperthyroidism.
- •History of sensitivity to omega-3 fatty acids, inositol or NAC. A non-responder or history of intolerance to omega-3 fatty acid, inositol or NAC after 2 months of treatment at adequate doses as determined by the clinician.
- •Severe allergies or multiple adverse drug reactions.
- •Unstable or untreated seizure disorder.
- •DSM-IV substance use, abuse or dependence.
- •Judged clinically to be at serious suicidal risk for C-SSRS score ≥
- •Current diagnosis of schizophrenia.
- •Current diagnosis or symptoms of psychosis.
- •Pregnant or nursing.
- •Weighs less than 12.5kg.
研究组 & 干预措施
Omega-3 Fatty Acids + Inositol
Subjects will be treated with 1020mg QAM + 1020mg QPM of omega-3 fatty acids and inositol based on weight (subjects under 25kg: 1000mg QD; Subjects weighing 25kg or more: 2000mg QD).
干预措施: Open-label Treatment with Omega-3 Fatty Acids + Inositol (Drug)
N-acetylcysteine
Subjects will be treated with N-acetylcysteine capsules (subjects ages 5-12: 1800mg QD; subjects ages 13-17: 2400 mg QD) or effervescent tablets (subjects ages 5-12: 1800mg QD; subjects ages 13-17: 2700 mg QD) based on age.
干预措施: Open-label Treatment with N-acetylcysteine (Drug)
结局指标
主要结局
Mean Change in the Parent-Young Mania Rating Scale (P-YMRS) Score
时间窗: Baseline to 6 Weeks
The YMRS consists of 11 items rated on a scale from 0 (symptoms not present) to 4 (symptoms extremely severe). It is used to assess manic symptoms. The YMRS score ranges from 0-60. Questions are asked about the last week. This scale is generally accepted as the main outcome measure in studies of pediatric bipolar disorder and is linked directly to the core symptoms of mania. Higher scores indicate more severe manic symptoms.
次要结局
- Mean Change in the Parent-completed Children's Depression Inventory (CDI)(Baseline to 6 Weeks)
- Mean Change in the NIMH Clinical Global Improvement Scale (CGI)(Baseline to 6 Weeks)
研究者
Janet Wozniak, MD
Assistant Professor of Psychiatry
Massachusetts General Hospital