PMID- 30641350
OWN - NLM
STAT- MEDLINE
DCOM- 20200330
LR  - 20240214
IS  - 1879-1379 (Electronic)
IS  - 0022-3956 (Print)
IS  - 0022-3956 (Linking)
VI  - 110
DP  - 2019 Mar
TI  - Sex differences in response to ketamine as a rapidly acting intervention for 
      treatment resistant depression.
PG  - 166-171
LID - S0022-3956(18)31131-2 [pii]
LID - 10.1016/j.jpsychires.2019.01.010 [doi]
AB  - 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.
CI  - Copyright (c) 2019 Elsevier Ltd. All rights reserved.
FAU - Freeman, Marlene P
AU  - Freeman MP
AD  - Massachusetts General Hospital, USA. Electronic address: mfreeman@partners.org.
FAU - Papakostas, George I
AU  - Papakostas GI
AD  - Massachusetts General Hospital, USA.
FAU - Hoeppner, Bettina
AU  - Hoeppner B
AD  - Massachusetts General Hospital, USA.
FAU - Mazzone, Erica
AU  - Mazzone E
AD  - Massachusetts General Hospital, USA.
FAU - Judge, Heidi
AU  - Judge H
AD  - Massachusetts General Hospital, USA.
FAU - Cusin, Cristina
AU  - Cusin C
AD  - Massachusetts General Hospital, USA.
FAU - Mathew, Sanjay
AU  - Mathew S
AD  - Baylor College of Medicine/Michael E. Debakey VA Medical Center, USA.
FAU - Sanacora, Gerard
AU  - Sanacora G
AD  - Yale University, USA.
FAU - Iosifescu, Dan
AU  - Iosifescu D
AD  - Icahn School of Medicine at Mount Sinai, USA.
FAU - DeBattista, Charles
AU  - DeBattista C
AD  - Stanford University School of Medicine, USA.
FAU - Trivedi, Madhukar H
AU  - Trivedi MH
AD  - University of Texas Southwestern, USA.
FAU - Fava, Maurizio
AU  - Fava M
AD  - Massachusetts General Hospital, USA.
LA  - eng
GR  - HHSN271201100006C/DA/NIDA NIH HHS/United States
GR  - HHSN271201100006I/DA/NIDA NIH HHS/United States
GR  - HHSN271201100006I/MH/NIMH NIH HHS/United States
GR  - R01 MH102279/MH/NIMH NIH HHS/United States
PT  - Journal Article
PT  - Randomized Controlled Trial
DEP - 20190108
PL  - England
TA  - J Psychiatr Res
JT  - Journal of psychiatric research
JID - 0376331
RN  - 0 (Antidepressive Agents)
RN  - 690G0D6V8H (Ketamine)
SB  - IM
MH  - Adolescent
MH  - Adult
MH  - Aged
MH  - Antidepressive Agents/*pharmacology
MH  - Depressive Disorder, Treatment-Resistant/*drug therapy
MH  - Female
MH  - Humans
MH  - Ketamine/*pharmacology
MH  - Male
MH  - Middle Aged
MH  - *Postmenopause/drug effects
MH  - *Premenopause/drug effects
MH  - *Sex Characteristics
MH  - Treatment Outcome
MH  - Young Adult
PMC - PMC6360121
MID - NIHMS1518554
OTO - NOTNLM
OT  - Depression
OT  - Ketamine
OT  - Menopause
OT  - Sex differences
OT  - Treatment resistant
EDAT- 2019/01/15 06:00
MHDA- 2020/03/31 06:00
PMCR- 2020/03/01
CRDT- 2019/01/15 06:00
PHST- 2018/09/19 00:00 [received]
PHST- 2019/01/03 00:00 [revised]
PHST- 2019/01/07 00:00 [accepted]
PHST- 2019/01/15 06:00 [pubmed]
PHST- 2020/03/31 06:00 [medline]
PHST- 2019/01/15 06:00 [entrez]
PHST- 2020/03/01 00:00 [pmc-release]
AID - S0022-3956(18)31131-2 [pii]
AID - 10.1016/j.jpsychires.2019.01.010 [doi]
PST - ppublish
SO  - J Psychiatr Res. 2019 Mar;110:166-171. doi: 10.1016/j.jpsychires.2019.01.010. 
      Epub 2019 Jan 8.