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Sex differences in response to ketamine as a rapidly acting intervention for treatment resistant depression.

Abstract：

BACKGROUND:While ketamine has been increasingly studied for treatment resistant depression (TRD), the impact of sex differences on treatment outcomes has not been well studied. The objective was to ascertain whether there were differences in response to a single administration of ketamine for TRD between men and women, and between pre- and post-menopausal women. METHODS:A randomized, double-blind, placebo-controlled trial (N = 99; N = 50 male; N = 49 female) was conducted to investigate the efficacy of intravenous ketamine versus active placebo as augmentation of antidepressant therapy for TRD. Patients were assigned to one of five arms; one-time administration of ketamine of varying doses (i.e., 0.1, 0.2, 0.5, and 1.0 mg/kg), and one group receiving active placebo (intravenous midazolam). A priori-planned analyses were conducted to compare responses between women and men, as well pre-vs. postmenopausal women. RESULTS:Analyses demonstrated no significant differences between women and men in terms of treatment response (F(1,80) = 0.06, p = 0.80). There were no significant differences in the frequency of adverse effects (AEs) reported by those assigned to ketamine treatment groups (p > 0.21 for all AEs reported more than once), although women reported more headaches (12% vs. 6%, p = 0.30) and nausea (10% vs. 6%, p = 0.47). In comparing pre-vs. postmenopausal women, no differences in efficacy were observed (F(1,76) = 0.36, p = 0.55). CONCLUSIONS:Results do not support differential efficacy or tolerability of ketamine for the treatment of TRD between women and men, nor based on menopause status among women. However, larger trials with these a priori aims are needed to confirm these results.

journal_name

J Psychiatr Res

journal_title

Journal of psychiatric research

authors

Freeman MP,Papakostas GI,Hoeppner B,Mazzone E,Judge H,Cusin C,Mathew S,Sanacora G,Iosifescu D,DeBattista C,Trivedi MH,Fava M

doi

10.1016/j.jpsychires.2019.01.010

subject

Has Abstract

pub_date

2019-03-01 00:00:00

pages

166-171

eissn

0022-3956

issn

1879-1379

pii

S0022-3956(18)31131-2

journal_volume

110

pub_type

杂志文章,随机对照试验

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Sex differences in response to ketamine as a rapidly acting intervention for treatment resistant depression.