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度洛西汀治疗共病的重度抑郁症和慢性头痛的8周开放标签试验。

An 8-week, open-label trial of duloxetine for comorbid major depressive disorder and chronic headache.

作者信息

Volpe Fernando M

机构信息

Liason-Psychiatry Service, Hospital SOCOR, Rua Pernambuco 353, sl.1505, Belo Horizonte-MG, Brazil, 30130-150.

出版信息

J Clin Psychiatry. 2008 Sep;69(9):1449-54. doi: 10.4088/jcp.v69n0912.

DOI:10.4088/jcp.v69n0912
PMID:19193344
Abstract

BACKGROUND

Although major depression and chronic headache are strongly associated, there is insufficient evidence for the use of antidepressants for this specific comorbidity. This trial aimed to investigate the efficacy and tolerability of duloxetine for this indication.

METHOD

Thirty outpatients with DSM-IV major depressive disorder and concurrent primary chronic headache (chronic migraine, chronic tension-type headache, or both), 18 to 55 years old, were recruited from April 2006 to March 2007, if they scored > 21 on the Montgomery-Asberg Depression Rating Scale (MADRS) and had no other significant clinical condition. Subjects received duloxetine 60 mg/day for 8 weeks. Scores on the MADRS and a visual analog pain scale (VAS) were the co-primary outcome measures. Scores on the brief version of the World Health Organization Quality of Life scale (WHOQoL-BREF) and number of headache days/week were secondary outcome measures. The study was conducted at the Liaison-Psychiatry Service of SOCOR General Hospital, Belo Horizonte, Brazil.

RESULTS

Mean +/- SD MADRS scores decreased significantly from baseline to endpoint (29.5 +/- 5.2 to 8.9 +/- 8.7 points, p < .001), and mean +/- SD VAS scores decreased significantly from 5.8 +/- 1.9 to 1.9 +/- 2.5 points (p < .001). Combined intent-to-treat response rate (> 50% reduction on MADRS and > 40% on VAS) was 66.7% (20/30). Significant improvements in both headache and depression were evident after the first week. Mean +/- SD WHOQoL-BREF scores increased (improved) 18.8 +/- 21.9 points (p < .001), and mean +/- SD number of headache days/week decreased from 5.2 +/- 2.0 to 2.9 +/- 2.5 days/week (p < .001). Two subjects discontinued for side effects and 3 for nonadherence.

CONCLUSION

In this preliminary open trial, duloxetine 60 mg/day was effective, fast acting, and well tolerated for the treatment of comorbid major depressive disorder and chronic headache.

摘要

背景

尽管重度抑郁症与慢性头痛密切相关,但对于这种特定的共病使用抗抑郁药的证据并不充分。本试验旨在研究度洛西汀用于该适应症的疗效和耐受性。

方法

2006年4月至2007年3月招募了30名年龄在18至55岁之间、患有DSM-IV重度抑郁症且并发原发性慢性头痛(慢性偏头痛、慢性紧张型头痛或两者皆有)的门诊患者,条件是他们在蒙哥马利-阿斯伯格抑郁评定量表(MADRS)上得分>21分且无其他重大临床疾病。受试者接受度洛西汀60毫克/天,持续8周。MADRS评分和视觉模拟疼痛量表(VAS)评分是共同主要结局指标。世界卫生组织生活质量量表简版(WHOQoL-BREF)评分和每周头痛天数是次要结局指标。该研究在巴西贝洛奥里藏特SOCOR综合医院的联络精神科进行。

结果

从基线到终点,平均±标准差MADRS评分显著降低(从29.5±5.2降至8.9±8.7分,p<.001),平均±标准差VAS评分从5.8±1.9显著降至1.9±2.5分(p<.001)。意向性治疗联合缓解率(MADRS降低>50%且VAS降低>40%)为66.7%(20/30)。第一周后头痛和抑郁均有显著改善。平均±标准差WHOQoL-BREF评分提高了18.8±21.9分(p<.001),平均±标准差每周头痛天数从5.2±2.0降至2.9±2.5天/周(p<.001)。两名受试者因副作用停药,三名因不依从停药。

结论

在这项初步开放性试验中,度洛西汀60毫克/天对治疗重度抑郁症和慢性头痛共病有效、起效快且耐受性良好。

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