Sheffrin Meera, Driscoll Henry C, Lenze Eric J, Mulsant Benoit H, Pollock Bruce G, Miller Mark D, Butters Meryl A, Dew Mary Amanda, Reynolds Charles F
Advanced Center in Interventions and Services Research for Late-Life Mood Disorders (ACISR/LLMD) and the John A Hartford Center of Excellence in Geriatric Psychiatry, University of Pittsburgh School of Medicine, Pittsburgh, PA 15213, USA.
J Clin Psychiatry. 2009 Feb;70(2):208-13. doi: 10.4088/jcp.07m03805. Epub 2009 Feb 10.
To determine the feasibility and safety of aripiprazole augmentation for incomplete response to sequential selective serotonin reuptake inhibitor (SSRI) and serotonin-norepinephrine reuptake inhibitor (SNRI) pharmacotherapy in late-life depression.
This study was a 12-week, open-label pilot study of 24 patients (recruited from June 1, 2006, to June 1, 2007) aged 65 years and above (mean, 73.9 years) diagnosed with major depressive disorder (MDD) (according to DSM-IV) who responded partially (17-item Hamilton Rating Scale for Depression [HAM-D-17] score of 11 to 15) or not at all (HAM-D score > 15) to a 16-week trial of escitalopram (up to 20 mg/day), followed by either duloxetine (up to 120 mg/day) or venlafaxine (up to 225 mg/day) for 12 weeks. Subjects received 2.5 to 15 mg per day of adjunctive aripiprazole (mean dose, 9.0 mg/day) for 12 weeks. The criterion for remission during treatment with aripiprazole was a HAM-D score < or = 10 for 2 consecutive weeks.
Of 24 subjects in the intent-to-treat study group, 19 completed 12 weeks of augmentation with aripiprazole, 12 of 24 (50%) met criteria for remission, and 2 of 24 discontinued due to side effects (sedation, akathisia). The mean (SD) HAM-D score decreased significantly by 6.4 (5.8) points (paired t test for means, p < .01, df = 16). There were no relapses among the 12 subjects who participated in continuation treatment over a median period of 27.6 weeks.
In older adults with MDD with incomplete response to SSRI and SNRI pharmacotherapy, aripiprazole was well tolerated, and symptoms of depression improved significantly during treatment with aripiprazole. A randomized, double-blind, placebo-controlled trial of adjunctive aripiprazole for incomplete response in late-life depression is warranted to further evaluate benefit and risk.
clinicaltrials.gov Identifier: NCT00177671.
确定阿立哌唑增效治疗对老年抑郁症患者在序贯使用选择性5-羟色胺再摄取抑制剂（SSRI）和5-羟色胺-去甲肾上腺素再摄取抑制剂（SNRI）药物治疗反应不完全时的可行性及安全性。
本研究为一项为期12周的开放标签试验性研究，共纳入24例年龄在65岁及以上（平均73.9岁）、根据《精神疾病诊断与统计手册》第四版（DSM-IV）诊断为重度抑郁症（MDD）的患者。这些患者在接受16周的艾司西酞普兰（最高剂量20mg/天）治疗后反应部分（17项汉密尔顿抑郁量表[HAM-D-17]评分为11至15分）或完全无反应（HAM-D评分>15分），随后接受度洛西汀（最高剂量120mg/天）或文拉法辛（最高剂量225mg/天）治疗12周。受试者接受为期12周的阿立哌唑辅助治疗，剂量为每天2.5至15mg（平均剂量9.0mg/天）。阿立哌唑治疗期间缓解的标准为HAM-D评分连续2周≤10分。
在意向性治疗研究组的24例受试者中，19例完成了12周的阿立哌唑增效治疗，24例中有12例（50%）达到缓解标准，24例中有2例因副作用（镇静、静坐不能）停药。HAM-D评分平均（标准差）显著下降6.4（5.8）分（均值配对t检验，p<.01，自由度=16）。在参与为期27.6周中位时间的继续治疗的12例受试者中无复发情况。
对于对SSRI和SNRI药物治疗反应不完全的老年MDD患者，阿立哌唑耐受性良好，且在阿立哌唑治疗期间抑郁症状显著改善。有必要进行一项关于阿立哌唑辅助治疗老年抑郁症反应不完全的随机、双盲、安慰剂对照试验，以进一步评估其益处和风险。
clinicaltrials.gov标识符：NCT00177671
