Omega-3 Fatty Acids in Adolescents with Depression

抑郁症青少年的 Omega-3 脂肪酸

• 批准号: 7275244
• 负责人: Vilma Gabbay
• 金额: $ 16.5万
• 依托单位: NEW YORK UNIVERSITY SCHOOL OF MEDICINE
• 依托单位国家: 美国
• 财政年份: 2005
• 资助国家: 美国
• 起止时间: 2005-09-30 至 2009-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7275244
• 关键词: Address; Adolescence; Adolescent; Adult; Adverse effects; Adverse event; Age; Anti-Inflammatory Agents; Anti-inflammatory; Antidepressive Agents; Attention deficit hyperactivity disorder; Autistic Disorder; Bipolar Disorder; Boxing; Cause of Death; Cell membrane; Child; Clinical; Clinical Research; Complementary and alternative medicine; Consumption; Country; Data; Data Analyses; Development; Diagnosis; Disadvantaged; Disease; Docosahexaenoic Acids; Dose; Double-Blind Method; Eating; Eating Disorders; Economics; Eicosapentaenoic Acid; Erythrocytes; Exploratory/Developmental Grant; Feeling suicidal; Fish Oils; Fishes; Foundations; Functional disorder; Funding; Gilles de la Tourette syndrome; Immune system; Impairment; Intervention; Link; Major Depressive Disorder; Mental Depression; Mental disorders; Methods; Mission; Mood Disorders; National Center for Complementary and Alternative Medicine; National Institute of Mental Health; Neurobiology; Neuroglia; Neurons; Obsessive-Compulsive Disorder; Omega-3 Fatty Acids; Outcome; Outcome Measure; Panic Disorder; Pathway interactions; Pervasive Development Disorder; Pilot Projects; Placebo Control; Placebos; Play; Population; Post-Traumatic Stress Disorders; Postpartum Depression; Prevalence; Prevention; Psychiatrist; Psychotic Disorders; Public Health; Randomized; Rate; Reporting; Resistance; Role; Schizophrenia; Score; Seafood; Seasonal Affective Disorder; Selective Serotonin Reuptake Inhibitor; Serotonin; Serum; Severities; Substance-Related Disorders; Suicide; Testing; Therapeutic; Therapeutic Effect; Titrations; United States Food and Drug Administration; Week; Youth; age group; base; biological research; boys; children' s depression rating scale; cost; design; functional disability; girls; improved; indexing; innovation; monoamine; neuron component; placebo controlled study; psychopharmacologic; response; social; suicidal risk

DESCRIPTION (provided by applicant): Objective. To provide preliminary data regarding the efficacy and tolerability of the omega-3 fatty acids (omega-3FA) docosahexaenoic acid (DMA) and eicosapentaenoic acid (EPA) in adolescents with major depression (MOD). Rationale. Evidence links central monoamine dysfunction, neurocellular alterations, and immune system dysregulation with MDD. Omega-3FA have been found to have powerful modulatory effects on central monoaminergic activity, are essential structural and functional components of neurons and glia, are effective anti-inflammatory agents, and may be effective in adult mood disorders. A body of epidemiological and neurobiological findings link omega-3FA and MDD. These related observations provide the basis for the proposed study. Hypothesis. Omega-3FA treatment is superior to placebo in adolescents with MDD. Methods. Subjects. 40 medically healthy, antidepressant nave adolescents, ages 12-18, with MDD for at least 8 weeks and a minimum severity score of >40 on the CDRS-R, and onset of first episode > 12 years. Diagnosis. MDD will be established with the K-SADS-PL. Excluded will be current and past: bipolar disorder, schizophrenia, psychosis, autism, pervasive developmental disorder, .and Tourette's disorder; current post traumatic stress disorder, panic disorder, obsessive-compulsive disorder, attention deficit hyperactivity disorder, conduct disorder, eating disorders, and substance related disorders. Study Treatments. Adolescents will be randomized to 10 weeks of double blind treatment with omega3-FA or matching placebo. Dose will be initiated at 1.2mg/d, titrated flexibly every 2 weeks up to a maximum of 3.6g/d. Omega3-FA will be combined EPA/DHA (ratio 2:1). A minimum of two weeks' duration at lower doses will provide the opportunity to assess clinical response at any one dose. Subjects will be followed weekly by a child psychiatrist. Assessments will include determination of MDD (K-SADS), MDD severity (Children's Depression Rating Scale-Revised [CDRS-R]), clinical global improvement (CGI), adverse events/vital signs, suicidal ideation, food intake checklist. Data Analyses. Two primary outcomes will be used to test the hypothesis: MDD severity indexed by CDRS total scores, and a CGI rating of 1 or 2 (Very Much or Much Improved). An intent to treat design will be applied, controlling for background food intake and other pertinent covariates, if appropriate. Significance. Adolescent MDD is associated with serious functional impairments, including suicide, and represents a major public health concern. In spite of its importance, it has been subject to relatively little biological research. This study stands at the confluence of current efforts to improve the treatment of adolescents with MDD and to develop alternative therapeutic approaches for this group. Should results of this pilot study suggest efficacy and tolerability of omega-3FA, we will plan a larger study to provide an adequate test of omega-3FA efficacy in this clinical population.

描述（由申请人提供）：目标。提供有关Omega-3脂肪酸（Omega-3FA）docosahexaenoic酸（DMA）和Eicosapentaenoic酸（EPA）对大抑郁症（MOD）青少年（MOD）的初步数据。理由。证据将中央单胺功能障碍，神经细胞改变和免疫系统失调与MDD联系起来。已经发现omega-3FA对中央单胺能活性具有强大的调节作用，是神经元和神经胶质的必不可少的结构和功能成分，是有效的抗炎剂，并且可能对成人情绪障碍有效。一个流行病学和神经生物学发现的身体链接Omega-3FA和MDD。这些相关的观察结果为拟议的研究提供了基础。假设。在MDD的青少年中，omega-3FA治疗优于安慰剂。方法。主题。 40医学健康的，抗抑郁药的青少年，年龄在12-18岁，MDD至少8周，CDRS-R的最低严重程度得分> 40，第一集的发作> 12岁> 12岁。诊断。 MDD将与K-SADS-PL建立。排除在当前和过去：躁郁症，精神分裂症，精神病，自闭症，普遍发育障碍，以及Tourette的障碍；当前的创伤后应激障碍，恐慌症，强迫症，注意力缺陷多动障碍，行为障碍，饮食失调和与物质有关的疾病。学习治疗。青少年将通过Omega3-FA或匹配的安慰剂随机分为10周的双盲治疗。剂量将以1.2mg/d的速度发起，每2周灵活地滴定，最多3.6g/d。 Omega3-FA将合并EPA/DHA（比率2：1）。较低剂量的至少持续时间至少两周，将提供任何一种剂量评估临床反应的机会。儿童精神科医生每周都会跟随受试者。评估将包括确定MDD（K-SADS），MDD严重程度（儿童抑郁评级评级为重新定义[CDRS-R]），临床全球改善（CGI），不良事件/生命体征，自杀意识，食品摄入量检查清单。数据分析。将使用两个主要结果来检验假设：由CDRS总分索引的MDD严重程度，CGI等级为1或2（非常或很大的提高）。如果适用，将采用治疗设计的意图，控制背景食品摄入量和其他相关的协变量。意义。青少年MDD与包括自杀在内的严重功能障碍有关，并代表了一个主要的公共卫生问题。尽管它的重要性，但它的生物学研究却相对较少。这项研究是目前努力通过MDD改善青少年治疗的努力的融合，并为该组开发了替代性治疗方法。如果这项试验研究的结果表明omega-3FA的功效和耐受性，我们将计划进行更大的研究，以提供对该临床人群中omega-3FA功效的足够测试。