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Non response at week 4 as clinically useful indicator for antidepressant combination in major depressive disorder. A sequential RCT.

Abstract：

:We aimed to compare the efficacy and tolerability of mirtazapine versus SSRIs and to assess whether "non-response at week 4" may be a clinical indicator for combining mirtazapine and SSRIs for subsequent treatment. One-hundred fifty-four outpatients with MDD were randomized to receive mirtazapine or SSRIs in step I (4 weeks). Non-responders in step I were randomly assigned to either mirtazapine or SSRIs monotherapy or their combination in step IIa while responders in step I continued the same monotherapy in step IIb for 4 weeks. In step I, mirtazapine showed significantly faster improvement as shown by higher remission rate at week 2 with NNT = 8 compared to SSRIs. Somnolence rate was higher in mirtazapine and nausea rate was higher in SSRIs. In step IIa, combination therapy showed a more favorable time course than SSRIs monotherapy. For subjects taking SSRIs in step I, combination therapy showed significant better improvement in the Hamilton Depression Rating (HAM-D) score both at week 6 (p = 0.006) and 8 (p = 0.013) than SSRIs monotherapy. About 80% of responders at week 4 could reach remission at week 8 and 64% of non-responders could not reach remission at week 8 for patients who continued monotherapy. When mirtazapine was added on for SSRIs non-responders at week 4, the remission rate increased by 5% and HAM-D score improved by 4 points. While for mirtazapine non-responders, SSRIs add-on was not equally effective. Mirtazapine may provide a faster improvement and "non-response at week 4" may be indicator to mirtazapine add-on for patients receiving SSRIs.

journal_name

J Psychiatr Res

journal_title

Journal of psychiatric research

authors

Kato M,Takekita Y,Koshikawa Y,Sakai S,Bandou H,Nishida K,Sunada N,Onohara A,Hatashita Y,Serretti A,Kinoshita T

doi

10.1016/j.jpsychires.2017.02.003

subject

Has Abstract

pub_date

2017-06-01 00:00:00

pages

97-104

eissn

0022-3956

issn

1879-1379

pii

S0022-3956(16)30826-3

journal_volume

89

pub_type

杂志文章,随机对照试验

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