小儿双相情感障碍是一种非常普遍和病态的疾病,被认为是普遍的公共卫生问题。目前批准的治疗通常会带来严重副作用的风险。因此,这项研究评估了N-乙酰半胱氨酸(NAC)的疗效和耐受性,在患有双相谱系障碍的儿童和青少年中。
我们进行了为期12周的NAC开放标签试验,用于治疗年龄在5-17岁的双相谱系障碍儿童和青少年的躁狂和轻躁狂,包括具有完全和阈值下躁狂症状的参与者。接受那些有和没有混合状态并伴有抑郁的人,青年躁狂症量表评分≥20分和<40分。躁狂症和抑郁症的症状使用年轻躁狂症评定量表(YMRS)进行评估,汉密尔顿抑郁量表(HDRS),儿童抑郁量表(CDRS)躁狂症和抑郁症的临床总体印象(CGI)严重程度(CGI-S)和改善(CGI-I)量表。
这项研究的辍学率很高,只有53%完成了所有12周。YMRS显着减少,HDRS,和CDRS从基线到终点的平均得分。在24名暴露的参与者中,54%的患者通过YMRS降低≥30%来测量抗躁狂反应,46%的患者在终点时CGI-I躁狂评分≤2。此外,62%的参与者有通过HDRS降低≥30%来衡量的抗抑郁反应。31%的人有通过CDRS降低≥30%来衡量的抗抑郁反应,38%的患者在终点时CGI-I抑郁评分≤2.
这些在小样本中的试点开放标签发现提供了支持NAC在儿科人群中的耐受性和安全性的初步数据。这项试点规模研究的结果表明躁狂症和抑郁症的改善是有希望的,但需要用单药随机安慰剂对照临床试验和更大的样本进行复制。
ClinicalTrials.gov标识符:NCT02357290。第一次注册06/02/2015。
Pediatric bipolar disorder is a highly prevalent and morbid disorder and is considered a prevalent public health concern. Currently approved treatments often pose the risk of serious side effects. Therefore, this
study assessed the efficacy and tolerability of N-acetylcysteine (NAC), in children and adolescents with bipolar spectrum disorder.
We conducted a 12-week open-label
trial of NAC for treatment of mania and hypomania in children and adolescents ages 5-17 with bipolar spectrum disorder including participants with full and subthreshold manic symptoms, accepting those with and without mixed states with co-occurring depression, and Young Mania Rating Scale scores ≥ 20 and < 40. Symptoms of mania and depression were assessed using the Young Mania Rating Scale (YMRS), Hamilton Depression Rating Scale (HDRS), Children\'s Depression Rating Scale (CDRS), and Clinical Global Impression (CGI) Severity (CGI-S) and Improvement (CGI-I) scales for mania and depression.
This
study had a high drop-out rate with only 53% completing all 12 weeks. There was a significant reduction in YMRS, HDRS, and CDRS mean scores from baseline to endpoint. Of the 24 exposed participants, 54% had an anti-manic response measured by a reduction in YMRS ≥ 30% and 46% had a CGI-I mania score ≤ 2 at endpoint. Additionally, 62% of participants had an anti-depressive response measured by a reduction in HDRS ≥ 30%, 31% had an anti-depressive response measured by a reduction in CDRS ≥ 30%, and 38% had a CGI-I depression score ≤ 2 at endpoint.
These pilot open-label findings in a small sample provide preliminary data supporting the tolerability and safety of NAC in a pediatric population. The findings of this pilot scale
study indicating improvement in mania and depression are promising, but require replication with a monotherapy randomized placebo controlled clinical
trial and larger sample.
ClinicalTrials.gov Identifier: NCT02357290 . First Registration 06/02/2015.