一项关于高二十碳五烯酸ω-3脂肪酸和肌醇作为单一疗法及联合疗法治疗儿童双相谱系障碍的随机临床试验：一项试点研究。

A randomized clinical trial of high eicosapentaenoic acid omega-3 fatty acids and inositol as monotherapy and in combination in the treatment of pediatric bipolar spectrum disorders: a pilot study.

作者信息

Wozniak Janet, Faraone Stephen V, Chan James, Tarko Laura, Hernandez Mariely, Davis Jacqueline, Woodworth K Yvonne, Biederman Joseph

机构信息

Clinical and Research Program in Pediatric Psychopharmacology, Massachusetts General Hospital, Boston.

Harvard Medical School, Boston, Massachusetts.

出版信息

J Clin Psychiatry. 2015 Nov;76(11):1548-55. doi: 10.4088/JCP.14m09267.

DOI:10.4088/JCP.14m09267

PMID:26646031

Abstract

OBJECTIVE

We conducted a 12-week, randomized, double-blind, controlled clinical trial to evaluate the effectiveness and tolerability of high eicosapentaenoic acid (EPA)/docosahexaenoic acid (DHA) omega-3 fatty acids and inositol as monotherapy and in combination in children with bipolar spectrum disorders.

METHOD

Participants were children 5-12 years of age meeting DSM-IV diagnostic criteria for bipolar spectrum disorders (bipolar I or II disorder or bipolar disorder not otherwise specified [NOS]) and displaying mixed, manic, or hypomanic symptoms. Subjects with severe illness were excluded. Subjects were randomized to 1 of 3 treatment arms: inositol plus placebo, omega-3 fatty acids plus placebo, and the combined active treatment of omega-3 fatty acids plus inositol. Data were collected from February 2012 to November 2013.

RESULTS

Twenty-four subjects were exposed to treatment (≥ 1 week of study completed) (inositol [n = 7], omega-3 fatty acids [n = 7], and omega-3 fatty acids plus inositol [n =10]). Fifty-four percent of the subjects completed the study. Subjects randomized to the omega-3 fatty acids plus inositol arm had the largest score decrease comparing improvement from baseline to end point with respect to the Young Mania Rating Scale (P < .05). Similar results were found for the Children's Depression Rating Scale (P < .05) and the Brief Psychiatric Rating Scale (P <.05).

CONCLUSION

Results of this pilot randomized, double-blind, controlled trial suggest that the combined treatment of omega-3 fatty acids plus inositol reduced symptoms of mania and depression in prepubertal children with mild to moderate bipolar spectrum disorders. Results should be interpreted in light of limitations, which include exclusion of severely ill subjects, 54% completion rate, and small sample size.

TRIAL REGISTRATION

ClinicalTrials.gov identifier: NCT01396486.

摘要

目的

我们开展了一项为期12周的随机双盲对照临床试验，以评估高二十碳五烯酸（EPA）/二十二碳六烯酸（DHA）ω-3脂肪酸及肌醇单药治疗以及联合治疗对双相谱系障碍儿童的有效性和耐受性。

方法

参与者为年龄在5至12岁、符合双相谱系障碍（双相I型或II型障碍或未另行规定的双相障碍[NOS]）的DSM-IV诊断标准且表现出混合、躁狂或轻躁狂症状的儿童。排除患有严重疾病的受试者。将受试者随机分为3个治疗组之一：肌醇加安慰剂、ω-3脂肪酸加安慰剂以及ω-3脂肪酸与肌醇联合的活性治疗组。数据收集时间为2012年2月至2013年11月。

结果

24名受试者接受了治疗（完成≥1周的研究）（肌醇组[n = 7]、ω-3脂肪酸组[n = 7]以及ω-3脂肪酸加肌醇组[n = 10]）。54%的受试者完成了研究。在根据Young躁狂评定量表比较从基线到终点的改善情况时，随机分配到ω-3脂肪酸加肌醇组的受试者得分下降幅度最大（P <.05）。儿童抑郁评定量表（P <.05）和简明精神病评定量表（P <.05）也得出了类似结果。