Safety Profile and Suicidality Associated with the Use of Esketamine in the Treatment of Major Depressive Disorder in European Countries: An EudraVigilance Database Analysis
Pharmaceuticals,
Год журнала:
2025,
Номер
18(5), С. 702 - 702
Опубликована: Май 9, 2025
Background/Objective:
Major
depressive
disorder
(MDD)
is
a
common
mental
disorder,
with
significant
portion
of
patients
developing
treatment-resistant
depression
(TRD).
Esketamine
an
antagonist
the
N-methyl-D-aspartate
receptor
indicated
as
nasal
spray
in
combination
other
antidepressants
for
adults
TRD.
Signals
suspected
adverse
reactions
(SARs)
to
esketamine
from
EudraVigilance
database
European
countries
were
analyzed
more
defined
safety
profile
this
drug
real
world.
Methods:
SARs
reported
data
system
analyzed,
and
disproportionality
analysis
indicating
suicidality
esketamine,
comparison
fluoxetine
venlafaxine,
was
performed.
Results:
Increases
blood
pressure
(15.4%)
dissociation
(15.0%)
most
frequently
SARs.
The
sex
distribution
indicates
prevalence
women,
except
increased
completed
suicide,
which
signaled
men,
while
(18–64
years)
elders
(65–85
ages
largest
number
esketamine.
results
indicate
existence
potential
increase
risk
suicide
depressed
taking
when
compared
venlafaxine.
Conclusions:
Apart
carefulness
due
known
limitations
pharmacovigilance
research
conducted
by
using
systems
spontaneous
signals
SARs,
points
toward
need
greater
attention
being
paid
following
prescription
subjects.
In
regard,
regulatory
agencies
also
recommend,
history
suicide-related
events
or
those
exhibiting
degree
suicidal
ideation
prior
beginning
treatment
should
receive
careful
monitoring
during
treatment.
Язык: Английский
BDNF/BDNF-AS Gene Polymorphisms Modulate Treatment Response and Remission in Bipolar Disorder: A Randomized Clinical Trial
Journal of Personalized Medicine,
Год журнала:
2025,
Номер
15(2), С. 62 - 62
Опубликована: Фев. 7, 2025
Background:
Bipolar
disorder
(BD)
is
a
chronic
condition
associated
with
treatment
resistance,
cognitive
decline,
structural
brain
changes,
and
an
approximately
13-year
reduction
in
life
expectancy
compared
to
the
general
population.
Depression
BD
substantially
impairs
quality
of
life,
while
neuroinflammation
excitotoxicity
are
thought
contribute
recurrence
mood
episodes
disease
progression.
Brain-derived
neurotrophic
factor
(BDNF)
plays
key
role
neuronal
growth
function,
its
dysregulation
being
linked
various
psychiatric
disorders.
This
study
extension
previously
published
clinical
trial
was
conducted
assess
effects
three
BDNF
BDNF-AS
gene
polymorphisms
(rs1519480,
rs6265,
rs10835210)
on
outcomes
serum
levels
patients
treatment-resistant
bipolar
depression
(TRBDD)
over
eight-week
period.
Methods:
included
41
participants
from
randomized
trial,
all
whom
had
available
samples
genotype
data.
The
participants,
aged
21
65,
were
diagnosed
disorder,
assessed
using
Maudsley
Staging
Method.
Participants
randomly
assigned
receive
either
escitalopram
plus
placebo
(ESC+PBO)
or
celecoxib
(ESC+CBX)
8-week
Statistical
analyses
mixed
ANOVA
chi-square
tests
compare
minor
allele
carrier
status
SNPs
response
remission
rates.
Results:
Non-carriers
rs6265
A
(p
=
0.005)
carriers
rs10835210
0.007)
showed
significantly
higher
adjunctive
alone.
Additionally,
rates
after
both
non-carriers
across
However,
notably
rs1519480
G
allele,
as
well
allele.
Conclusions:
suggests
that
genetic
variations
genes
influence
disorder.
Язык: Английский