Findling Robert L, McNamara Nora K, Youngstrom Eric A, Stansbrey Robert J, Frazier Thomas W, Lingler Jacqui, Otto Benjamin D, Demeter Christine A, Rowles Brieana M, Calabrese Joseph R
Department of Psychiatry, University Hospitals Case Medical Center, Case Western Reserve University, Cleveland, Ohio 44106, USA.
J Child Adolesc Psychopharmacol. 2011 Aug;21(4):345-51. doi: 10.1089/cap.2010.0102. Epub 2011 Aug 8.
The purpose of this open-label study was to describe the effectiveness of aripiprazole (APZ) in the treatment of children with bipolar disorders suffering from manic symptomatology.
Symptomatic outpatients (Young Mania Rating Scale [YMRS] score ≥15) meeting strict, unmodified, Diagnostic and Statistical Manual of Mental Disorders, 4th edition, diagnostic symptom criteria for a bipolar disorder, ages 4-9 years, were eligible. Subjects were treated prospectively with flexible doses of APZ (maximum daily dose of 15 mg/day), for up to 16 weeks or until a priori response criteria were met. Outcome measures included the YMRS, Clinical Global Impressions Scale-Severity, Children's Global Assessment Scale (CGAS), and the Children's Depression Rating Scale-Revised (CDRS-R). A priori response criteria consisted of 3 of 4 consecutive weeks with (1) CDRS-R <29; (2) YMRS <10; and (3) CGAS >50.
Ninety-six children (62 males; mean age of 6.9 (SD = 1.7), received APZ for an average length of treatment of 12.5 (SD = 3.9) weeks. Significant improvements in YMRS, CDRS-R, CGAS, and Clinical Global Impressions Scale-Severity scores (p < 0.001) were noted at the end of study participation. Sixty of the subjects (62.5%) met a priori response criteria at study's end. The most common side effects noted were stomachache, increased appetite, and headache. Two subjects were removed from the study due to side effects [epistaxis (n = 1); akathisia (n = 1)]. Subjects experienced an average weight gain of 2.4 (SD = 1.9) kg.
APZ may be effective in the acute treatment of symptoms of children with bipolar illnesses.
本开放标签研究旨在描述阿立哌唑（APZ）治疗患有躁狂症状的双相情感障碍儿童的有效性。
符合严格的、未修改的《精神疾病诊断与统计手册》第4版双相情感障碍诊断症状标准、年龄在4至9岁的有症状门诊患者（杨氏躁狂评定量表[YMRS]评分≥15）符合入选条件。受试者前瞻性地接受灵活剂量的APZ治疗（最大日剂量为15毫克/天），治疗长达16周或直至达到预先设定的反应标准。疗效指标包括YMRS、临床总体印象量表-严重程度、儿童总体评估量表（CGAS）和儿童抑郁评定量表修订版（CDRS-R）。预先设定的反应标准包括连续4周中有3周满足以下条件：（1）CDRS-R<29；（2）YMRS<10；（3）CGAS>50。
96名儿童（62名男性；平均年龄6.9岁（标准差=1.7））接受APZ治疗，平均治疗时长为12.5周（标准差=3.9）。在研究结束时，YMRS、CDRS-R、CGAS和临床总体印象量表-严重程度评分有显著改善（p<0.001）。60名受试者（62.5%）在研究结束时达到预先设定的反应标准。最常见的副作用是胃痛、食欲增加和头痛。两名受试者因副作用退出研究[鼻出血（n = ；静坐不能（n = 。受试者平均体重增加2.4千克（标准差=1.9）。
APZ可能对双相情感障碍儿童症状的急性治疗有效。
