Safety, tolerability, and clinical effect of low-dose buprenorphine for treatment-resistant depression in midlife and older adults.
Safety, tolerability, and clinical effect of low-dose buprenorphine for treatment-resistant depression in midlife and older adults.
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DOI：
10.4088/jcp.13m08725
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发表时间：
2014-08
期刊：
影响因子：
--
通讯作者：
Reynolds CF 3rd
中科院分区：
文献类型：
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作者：
Karp JF;Butters MA;Begley AE;Miller MD;Lenze EJ;Blumberger DM;Mulsant BH;Reynolds CF 3rd
描述低剂量丁丙诺啡（一种κ阿片受体拮抗剂）治疗中年和老年人难治性抑郁症（TRD）的临床疗效和安全性。使用开放标签方案，在2010年6月至2011年6月期间，为15名50岁及以上TRD成人（诊断为DSM-IV的SCID）开具丁丙诺啡处方。丁丙诺啡的滴定剂量范围为0.2 mg-1.6 mg/天。我们评估了抑郁、焦虑、睡眠、积极和消极情绪以及生活质量的临床变化。通过记录生命体征、体重、认知功能和副作用的变化来评估耐受性。在停用丁丙诺啡后8周评估临床反应持久性。丁丙诺啡的平均剂量为0.4 mg/天（平均最大剂量= 0.7 mg/天）。基线时的平均抑郁评分（MADRS）为27.0（SD=7.3）;第8周时为9.5（SD=9.5）。在暴露的前三周，抑郁症的严重程度急剧下降（平均delta=-15.0（SD=7.9））。利用悲观和悲伤情绪的抑郁症特定项目在接触期间得到改善，支持真正的抗抑郁作用。治疗后出现的副作用（特别是恶心和便秘）没有持续，生命体征和体重保持稳定，执行功能和学习从治疗前到治疗后得到改善。低剂量丁丙诺啡可能是一种新的机制药物，为老年TRD患者提供快速和持续的改善。需要更长时间的安慰剂对照试验来评估延长暴露于这种药物的疗效，安全性以及生理和心理影响。
Describe the clinical effect and safety of low-dose buprenorphine, a kappa-opioid receptor antagonist, for treatment-resistant depression (TRD) in mid-life and older adults. Using an open-label protocol, buprenorphine was prescribed for 15 adults age 50 and older with TRD, diagnosed with the SCID for DSM-IV, between 6/2010-6/2011. The titrated dose of buprenorphine ranged from 0.2 mg-1.6 mg/day. We assessed clinical change in depression, anxiety, sleep, positive and negative affect, and quality of life. Tolerability was assessed by documenting change in vital signs, weight, cognitive function, and side effects. Clinical response durability was assessed 8 weeks after discontinuation of the buprenorphine. The average dose of buprenorphine was 0.4 mg/day (average maximum dose = 0.7 mg/day). The average depression score (MADRS) at baseline was 27.0 (SD=7.3); and at week 8, 9.5 (SD=9.5). There was a sharp decline in depression severity during the first three weeks of exposure (mean delta=−15.0 (SD=7.9)). Depression-specific items tapping pessimism and sadness improved during exposure, supporting a true antidepressant effect. Treatment emergent side effects (in particular nausea and constipation) were not sustained, vital signs and weight remained stable, and executive function and learning improved from pre- to post-treatment. Low-dose buprenorphine may be a novel-mechanism medication that provides a rapid and sustained improvement for older adults with TRD. Placebo-controlled trials of longer duration are required to assess efficacy, safety, and physiological and psychological effects of extended exposure to this medication.