A double-blind, randomized, placebo-controlled study of quetiapine as adjunctive treatment for adolescent mania
A double-blind, randomized, placebo-controlled study of quetiapine as adjunctive treatment for adolescent mania
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DOI：
10.1097/00004583-200210000-00011
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发表时间：
2002-10-01
影响因子：
13.3
通讯作者：
Strakowski, SM
中科院分区：
文献类型：
--
作者：
DelBello, MP;Schwiers, ML;Strakowski, SM
目的：这项随机、双盲、安慰剂对照研究检验了喹硫平联合双丙戊酸 (DVP) 对双相情感障碍青少年急性躁狂的疗效和耐受性。据推测，对于治疗与青少年双相情感障碍相关的躁狂症，DVP 与喹硫平联用比单独使用 DVP 更有效。此外，假设喹硫平具有良好的耐受性。方法：30 名躁狂或混合性双相 I 型青少年（12-18 岁）接受了 20 mg/kg 的初始 DVP 剂量，并被随机分配接受为期 6 周的喹硫平联合治疗，随后滴定至 450 mg/天（n = 15）或安慰剂（n = 15）。主要疗效指标是年轻躁狂评定量表 (YMRS) 评分和 YMRS 反应率从基线到终点的变化。每周评估安全性和耐受性。结果：与 DVP + 安慰剂组相比，DVP + 喹硫平组的 YMRS 评分从基线到终点的降低具有统计学意义（F-1.27 = 5.04，p = .03）。此外，DVP + 喹硫平组的 YMRS 反应率显着高于 DVP + 安慰剂组（87% 对比 53%；Fisher 精确检验，p = .05）。在安全措施方面，从基线到终点没有显着的组间差异。 DVP + 喹硫平组中轻度或中度镇静的发生率明显高于 DVP + 安慰剂组。结论：本研究结果表明，喹硫平联合 DVP 治疗青少年双相躁狂比单独使用 DVP 更有效。此外，结果表明喹硫平与 DVP 联合用于治疗躁狂症时具有良好的耐受性。
Objectives: This randomized, double-blind, placebo-controlled study examined the efficacy and tolerability of quetiapine in combination with divalproex (DVP) for acute mania in adolescents with bipolar disorder. It was hypothesized that DVP in combination with quetiapine would be more effective than DVP alone for treating mania associated with adolescent bipolar disorder. Furthermore, it was hypothesized that quetiapine would be well tolerated. Method: Thirty manic or mixed bipolar I adolescents (12-18 years) received an initial DVP dose of 20 mg/kg and were randomly assigned to 6 weeks of combination therapy with quetiapine, which was titrated to 450 mg/day (n = 15) or placebo (n = 15). Primary efficacy measures were change from baseline to endpoint in Young Mania Rating Scale (YMRS) score and YMRS response rate. Safety and tolerability were assessed weekly. Results: The DVP + quetiapine group demonstrated a statistically significantly greater reduction in YMRS scores from baseline to endpoint than the DVP + placebo group (F-1.27 = 5.04, p = .03). Moreover, YMRS response rate was significantly greater in the DVP + quetiapine group than in the DVP + placebo group (87% versus 53%; Fisher exact test, p = .05). No significant group differences from baseline to endpoint in safety measures were noted. Sedation, rated as mild or moderate, was significantly more common in the DVP + quetiapine group than in the DVP + placebo group. Conclusions: The findings of this study indicate that quetiapine in combination with DVP is more effective for the treatment of adolescent bipolar mania than DVP alone. In addition, the results suggest that quetiapine is well tolerated when used in combination with DVP for the treatment of mania.