Trajectories of depression symptom improvement and associated predictor analysis: An analysis of duloxetine in double-blind placebo-controlled trials

JOURNAL OF AFFECTIVE DISORDERS

卷:196

Article

Tokuoka, Hirofumi¹  Takahashi, Hitoshi²  Ozeki, Akichika³  Kuga, Atsushi¹  Yoshikawa, Aki⁴  Tsuji, Toshinaga⁵  Wohlreich, Madelaine M.⁶ 

[1] Eli Lilly Japan KK, Neurosci & Pain Prod, Biomed, Med Dev Unit Japan, Kobe, Hyogo 6510086, Japan

[2] Tokyo Womens Med Univ, Dept Psychiat, Tokyo, Japan

[3] Eli Lilly Japan KK, Med Dev Unit Japan, Stat Sci, Kobe, Hyogo 6510086, Japan

[4] Eli Lilly Japan KK, Med Dev Unit Japan, Sci Commun, Kobe, Hyogo 6510086, Japan

[5] Shionogi & Co Ltd, Med Affairs Dept, Osaka, Osaka, Japan

[6] Eli Lilly & Co, Neurosci, Indianapolis, IN 46285 USA

关键词: Duloxetine;    Trajectory;    Depression;    Remission;    Predictor;    Placebo;   

DOI  :  10.1016/j.jad.2016.02.039

来源: Elsevier

【 摘 要 】

Background: In the treatment of major depressive disorder (MDD), it is not fully understood how individual symptoms improve over time (trajectory) in remitters. This study compared symptom improvement trajectories, as measured with the 17-item Hamilton Depression Rating Scale (HAM-D17), in remitters and nonremitters. Methods: This analysis is based on 10 placebo-controlled, randomized, double-blind trials of duloxetine (40-60 mg/day) for treatment of MDD from baseline up to week 8. Remission was defined as a HAM-D17 total score < 7 at week 8 (last observation carried forward). Trajectories of HAM-D17 items were assessed by mixed model repeated measures analysis for treatment and remitter-nonremitter comparisons. Grouping of the trajectories was performed by factor analysis. Predictor analysis using HAM-D17 items was conducted by logistic regression. Results: There were 1555 patients in the duloxetine group (489 [31.4%] remitters) and 1206 patients in the placebo group (290 [24.0%] remitters; P<.0001). For most items, the difference in trajectories between remitters and nonremitters appeared at early time points and increased over time. Treatment response trajectories were very similar for duloxetine and placebo remitters, while duloxetine non remitters improved more than placebo nonremitters. For duloxetine remitters, we found 3 trajectory groups of HAM-D17 items. The predictor analysis showed that improvement in 6 individual items at week 1 or 2 was significantly associated with remission at week 8. Limitations: Generalizability of these results may be limited by the relatively short observation period used to define remission. Conclusions: Early monitoring of some symptoms of depression may prove useful in guiding treatment decisions. (C) 2016 The Authors. Published by Elsevier B.V.

【 授权许可】

Free