Pilot study of the efficacy of double-blind, placebo-controlled one-week olanzapine stabilization therapy in heterogeneous symptomatic bipolar disorder patients

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• 作者：Shefali Srivastava ; Po W. Wang ; Shelley J. Hill ; Meredith E. Childers ; Kristine L. Keller ; Terence A. Ketter ; ^{tketter@stanford.edu}
• 关键词：Bipolar ; Treatment ; Olanzapine ; Brief therapy ; Pilot study
• 刊名：Journal of Psychiatric Research
• 出版年：2012
• 期刊代码：169_00223956
• 类别：med
• 出版时间：July, 2012
• 卷：46
• 期：7
• 页码：920-926
• 文件大小：306 K

摘要

Background

Olanzapine has demonstrated efficacy in acute mania and bipolar I disorder (BDI) maintenance, but efficacy in brief therapy in more diverse populations, including patients with bipolar II disorder (BDII)/bipolar disorder not otherwise specified (BDNOS) with syndromal/subsyndromal depressive/mood elevation symptoms and taking/not taking concurrent medications remains to be established.

Methods

Fifty adult outpatients (24 BD1, 22 BDII, 4 BDNOS, mean聽卤聽SD age 40.8聽卤聽11.5 years, 28.1%female, already taking 1.1聽卤聽1.2 [median 1] prescription psychotropics) with 17-item Hamilton Depression Rating Scale (HDRS) 鈮?0 and/or Young Mania Rating Scale (YMRS) 鈮?0 and 鈮?4, were randomized to double-blind olanzapine (2.5-20聽mg/day) versus placebo for one week.

Results

Among 45 patients with post-baseline ratings, olanzapine (9.0聽卤聽5.8聽mg/day, n聽=聽23) compared to placebo (n聽=聽22) tended to yield greater Clinical Global Impressions-Bipolar Version-Overall Severity of Illness (鈭?.4聽卤聽0.9 versus 鈭?.8聽卤聽1.1, p聽=聽0.08) and Hamilton Anxiety Scale (鈭?.9聽卤聽6.3 versus 鈭?.8聽卤聽6.1, p聽=聽0.07) improvements, and YMRS/HDRS remission rate (47.8%versus 22.7%, p聽=聽0.08), but significantly increased median weight (+2 versus 鈭?聽lbs, p聽=聽0.001), and rates of excessive appetite (54.2%versus 22.7%, p聽=聽0.04) and tremor (50.0%versus 9.1%p聽=聽0.004). Number Needed to Treat and 95%Confidence Interval for YMRS/HDRS remission were 4 (1-鈭?. Numbers Needed to Harm for excessive appetite and tremor were 4 (1-21) and 3 (1-6), respectively.

Conclusions

Olanzapine tended to yield affective improvement and significantly increased weight, appetite, and tremor. Larger controlled studies appear feasible and warranted to assess brief olanzapine therapy in heterogeneous symptomatic bipolar disorder patients.