Biederman Joseph, Mick Eric, Hammerness Paul, Harpold Theresa, Aleardi Megan, Dougherty Meghan, Wozniak Janet
Pediatric Psychopharmacology Research Department, Massachusetts General Hospital, Boston, Massachusetts 02114, USA.
Biol Psychiatry. 2005 Oct 1;58(7):589-94. doi: 10.1016/j.biopsych.2005.03.019.
To evaluate short-term safety and efficacy of atypical antipsychotics in a single-site, prospective, open-label, 8-week study of risperidone and olanzapine monotherapy in preschoolers with bipolar disorder (BPD).
Risperidone was initiated at an open-label dose of .25 mg/day, increased weekly according to response and tolerability to a maximum does of 2.0 mg/day. Olanzapine was initiated at 1.25 mg/day and increased to no more than 10 mg/day.
Thirty-one children aged 4-6 years were treated with olanzapine (n = 15, 6.3 +/- 2.3 mg/day) or risperidone (n = 16, 1.4 +/- .5 mg/day). At study end point (week 8 or last observation carried forward), there was a 18.3 +/- 11.9 point (t = -5.6, p < .001) reduction in risperidone-treated subjects and a 12.1 +/- 10.4 point (t = -4.4, p < .001) reduction in Young Mania Rating Scale (YMRS) scores in olanzapine-treated subjects that did not differ between groups (t = 1.4, p = .2). Response criteria (Clinical Global Impression improvement of "Much" or "Very Much" improved or a YMRS change of >or= 30% or more) indicated no difference in rate of response with risperidone and olanzapine (69% vs. 53%, chi(2)((1)) = .8, p = .4).
This prospective open study suggests that treatment with risperidone or olanzapine may result in a rapid reduction of symptoms of mania in preschool children with BPD. Because of substantial residual symptomatology and adverse effects, however, a pressing need exists to identify additional safe and effective treatments for the management of BPD in this high-risk population.
在一项针对双相情感障碍（BPD）学龄前儿童的利培酮和奥氮平单药治疗的单中心、前瞻性、开放标签、为期8周的研究中，评估非典型抗精神病药物的短期安全性和疗效。
利培酮起始剂量为开放标签剂量0.25毫克/天，根据反应和耐受性每周增加剂量，最大剂量为2.0毫克/天。奥氮平起始剂量为1.25毫克/天，增加至不超过10毫克/天。
31名4至6岁儿童接受了奥氮平（n = 15，6.3 ± 2.3毫克/天）或利培酮（n = 16，1.4 ± 0.5毫克/天）治疗。在研究终点（第8周或末次观察向前结转）时，利培酮治疗组受试者的杨氏躁狂评定量表（YMRS）评分降低了18.3 ± 11.9分（t = -5.6，p < 0.001），奥氮平治疗组受试者的YMRS评分降低了12.1 ± 10.4分（t = -4.4，p < 0.001），两组之间无差异（t = 1.4，p = 0.2）。反应标准（临床总体印象改善为“明显”或“非常明显”改善，或YMRS变化≥30%或更多）表明，利培酮和奥氮平的反应率无差异（69%对53%，χ²(1) = 0.8，p = 0.4）。
这项前瞻性开放研究表明，利培酮或奥氮平治疗可能会使患有BPD的学龄前儿童的躁狂症状迅速减轻。然而，由于存在大量残留症状和不良反应，迫切需要为这一高危人群确定额外的安全有效的BPD治疗方法。
