Walker Daniel J, DelBello Melissa P, Landry John, D'Souza Deborah N, Detke Holland C
Eli Lilly and Company, Lilly Research Laboratories, Lilly Corporate Center, Indianapolis, IN 46285 USA.
Division of Bipolar Disorders Research, Department of Psychiatry and Behavioral Neuroscience, University of Cincinnati College of Medicine, Cincinnati, OH USA.
Child Adolesc Psychiatry Ment Health. 2017 Jul 12;11:34. doi: 10.1186/s13034-017-0170-7. eCollection 2017.
We examined the efficacy of olanzapine/fluoxetine combination (OFC) in improving health-related quality of life (QoL) in the treatment of bipolar depression in children and adolescents.
Patients aged 10-17 years with bipolar I disorder, depressed episode, baseline children's depression rating scale-revised (CDRS-R) total score ≥40, Young Mania Rating Scale (YMRS) total score ≤15, and YMRS-item 1 ≤ 2 were randomized to OFC (6/25-12/50 mg/day olanzapine/fluoxetine; n = 170) or placebo (n = 85) for up to 8 weeks of double-blind treatment. Patients and parents completed the revised KINDL questionnaire for measuring health-related QoL in children and adolescents (KINDL-R) at baseline and endpoint. The mean change in CDRS-R total and item scores were used to compare improvement in symptomatology in patients taking OFC and placebo. Tests were 2-sided using a Type I error cutoff of 0.05, and no adjustments for multiple comparisons were made.
Baseline QoL as measured by the KINDL-R was substantially impaired relative to published norms for a healthy school-based sample. OFC-treated patients demonstrated an improvement over placebo at endpoint with respect to mean change from baseline in the patient-rated KINDL-R Self-esteem subscale score ( = 0.028), and in the parent KINDL-R ratings of emotional well-being ( = 0.020), Self-esteem ( = 0.030), and Family ( = 0.006). At endpoint, OFC-treated patients still had a lower QoL compared to the normative population. OFC showed significant improvement ( ≤ 0.05) versus placebo on the CDRS-R total score and on 7 of the 17 CDRS-R items.
Patients aged 10-17 years with an acute episode of bipolar depression and their parents reported greater improvements (parents noticed improvements in more areas than did their offspring) on some aspects of QoL when treated with OFC compared with placebo. However, after 8 weeks of treatment, KINDL-R endpoint scores remained lower than those of the, presumably healthy, control population. A Study for Assessing Treatment of Patients Ages 10-17 with Bipolar Depression; http://www.clinicaltrials.gov; NCT00844857.
我们探讨了奥氮平/氟西汀组合（OFC）在改善儿童和青少年双相抑郁治疗中与健康相关的生活质量（QoL）方面的疗效。
年龄在10 - 17岁、患有双相I型障碍、抑郁发作、儿童抑郁评定量表修订版（CDRS - R）总分≥40、Young躁狂评定量表（YMRS）总分≤15且YMRS第1项≤2的患者被随机分为OFC组（奥氮平/氟西汀6/25 - 12/50毫克/天；n = 170）或安慰剂组（n = 85），进行长达8周的双盲治疗。患者和家长在基线和终点时完成用于测量儿童和青少年与健康相关QoL的修订版KINDL问卷（KINDL - R）。使用CDRS - R总分和项目得分的平均变化来比较服用OFC和安慰剂患者的症状改善情况。检验采用双侧检验，I类错误临界值为0.05，未进行多重比较调整。
通过KINDL - R测量的基线QoL相对于基于健康在校样本的已发表规范有显著损害。在终点时，OFC治疗的患者在患者自评的KINDL - R自尊子量表得分从基线的平均变化方面（P = 0.028），以及在家长对KINDL - R的情绪幸福感（P = 0.020）、自尊（P = 0.030）和家庭（P = 0.006）评分方面，相对于安慰剂组有改善。在终点时，OFC治疗的患者与正常人群相比QoL仍较低。在CDRS - R总分以及17项CDRS - R中的7项上，OFC相对于安慰剂显示出显著改善（P≤0.05）。
年龄在10 - 17岁患有双相抑郁急性发作的患者及其家长报告，与安慰剂相比，接受OFC治疗时在QoL的某些方面有更大改善（家长注意到的改善领域比其子女更多）。然而，经过8周治疗后，KINDL - R终点得分仍低于可能健康的对照人群。一项评估10 - 17岁双相抑郁患者治疗的研究；http://www.clinicaltrials.gov；NCT00844857。
