A Pilot Study of Omega-3 Fatty Acid Supplementation to ADHD Medication in Children With ADHD and Deficits in Emotional Self-Regulation
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 21
- 试验地点
- 1
- 主要终点
- Emotional Control Subscale of the Behavior Rating Inventory of Executive Function - Parent Form (BRIEF-Parent)
研究概览
简要总结
This study is a 12-week open-label trial to assess the effectiveness of Omega-3 fatty acids for deficient emotional self-regulation (DESR) as a supplement to Attention Deficit/Hyperactivity Disorder (ADHD) treatment in children and adolescents with Attention Deficit/Hyperactivity Disorder. Subjects will be between the ages of 6-17 and will currently be on medication for their Attention Deficit/Hyperactivity Disorder but still experience DESR traits.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 6 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female children ages 6-17 years
- •Living at home
- •A diagnosis of ADHD (inattentive, hyperactive/impulsive, or combined type) according to the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-V) based on clinical assessment
- •Having a score outside the normal (a T-score of 60 or greater) on the Emotional Control subscale of the Behavior Rating Inventory of Executive Function (parent-report version) or a score outside the normal range (cumulative of 180 or greater) on the Anxious/Depressed, Attention Problems, and Aggressive Behavior subscales of the Child Behavior Checklist for ages (6-18)
- •Currently on FDA approved traditional stimulant medication (such as Concerta of Adderall XR) or non-stimulant medication (such as Strattera or Tenex) for their ADHD for at least one month
- •Beings able to come to weekly/monthly study visits for 12 weeks
- •Having a parent or guardian with a level of understanding of the study
排除标准
- •Having unstable medical illness as determined by the clinician investigator
- •Having a current diagnosis of schizophrenia or bipolar disorder
- •Having delusions or hallucinations
- •Having a bleeding disorder
- •Taking any other ongoing non-ADHD psychotropic medications other than stable, effective serotonin reuptake inhibitors such as fluoxetine (Prozac), citalopram (Celexa) or medications used on an as-needed basis
- •Pregnant or nursing females
- •IQ < 70 by previous testing or as judged by the clinician investigator
- •Illegal substance use
- •Investigator and his/her immediate family; defined as the investigator's spouse, parent, child, grandparent, or grandchild
- •Presence of suicidal risk, or homicidality
- •Unwilling/unable to comply with study procedures
- •Allergies to fish or shellfish or omega 3 fish oils; multiple adverse drug reactions
- •Poor command of the English language
研究组 & 干预措施
Omega-3 Fatty Acids and Stimulant Treatment
Participants will receive open-label treatment with Omega-3 Fatty Acids. All participants must also be treated with a stable dose of a traditional ADHD medication at the time of enrollment.
干预措施: Omega-3 Fatty Acid (Dietary Supplement)
Omega-3 Fatty Acids and Stimulant Treatment
Participants will receive open-label treatment with Omega-3 Fatty Acids. All participants must also be treated with a stable dose of a traditional ADHD medication at the time of enrollment.
干预措施: ADHD Medication (Drug)
结局指标
主要结局
Emotional Control Subscale of the Behavior Rating Inventory of Executive Function - Parent Form (BRIEF-Parent)
时间窗: Baseline and 12 Weeks
The Behavior Rating Inventory of Executive Function - Parent Form (BRIEF-Parent) is a 75-item checklist with a large normative sample, internal consistency, test-retest reliability, inter-rater reliability, and external and concurrent validity, divided into nine empirically and theoretically derived and T-scored subscales. The Emotional Control subscale measures the impact of executive function problems on emotional expression and assesses a child's ability to modulate or control his or her emotional responses. It is a 10-item subscale, and each item is scored "Never," "Sometimes," or "Often." Raw scores for all scales are computed with Software Portfolio (BRIEF-SP), which provides a raw score and T score (based on child's age) for each scale. Higher scores represent more greater emotional dysregulation.
Clinical Global Impression (CGI) Improvement for Deficient Emotional Self-Regulation (DESR)
时间窗: Baseline and 12 Weeks
The Clinical Global Impression (CGI) is a clinician rated measure of illness severity, improvement, and efficacy of treatment (collected at all study visits). We examined the CGI Improvement specifically. The CGI Improvement for Deficient Emotional Self-Regulation (DESR) was reported at baseline and completion. The CGI-I is a 7 point scale that requires the clinician to assess how much the patient's illness has improved or worsened relative to a baseline state at the beginning of the intervention. It is rated as: 1. Very much improved 2. Much improved 3. Minimally improved 4. No change 5. Minimally worse 6. Much worse 7. Very much worse
次要结局
未报告次要终点
研究者
Timothy Wilens, MD
Senior Staff, Pediatric Psychopharmaoclogy and Adult ADHD Clinic and Research Program; Associate professor of Psychiatry, Harvard Medical School; Director, Center for Addiction Medicine
Massachusetts General Hospital