Journal of Clinical Psychopharmacology,
Journal Year:
2024,
Volume and Issue:
unknown
Published: May 13, 2024
Abstract
Purpose/Background
Zuranolone
is
a
positive
allosteric
modulator
of
both
synaptic
and
extrasynaptic
γ-aminobutyric
acid
type
A
receptors
neuroactive
steroid
approved
as
an
oral,
once-daily,
14-day
treatment
course
for
adults
with
postpartum
depression
in
the
United
States.
This
study
assessed
zuranolone
transfer
into
breast
milk.
Methods/Procedures
Healthy,
nonpregnant,
lactating
adult
female
participants
received
once-daily
30
mg
from
day
(D)1
through
D5
this
phase
1
open-label
study.
The
relative
infant
dose
(RID;
weight-adjusted
proportion
maternal
milk
over
24
hours)
was
at
D5.
An
RID
50
estimated
using
simulation
approach
across
range
ages
weights.
Findings/Results
Of
15
enrolled
(mean
age,
30.1
years),
14
completed
mean
0.357%;
steady-state
volume
D3
to
decreased
baseline
by
8.3%.
Overall
unbound
plasma
low
(≤0.49%).
Plasma
concentrations
peaked
before
decreasing
biexponential
manner.
There
strong
concordance
between
temporal
evolution
based
on
intake
200
mL/kg
per
0.984%.
All
treatment-emergent
adverse
events
reported
were
mild,
most
common
being
dizziness
(n
=
3).
Implications/Conclusions
healthy,
low;
<1%,
well
below
<10%
threshold
generally
considered
compatible
breastfeeding.
JAMA Surgery,
Journal Year:
2024,
Volume and Issue:
159(10), P. 1127 - 1127
Published: July 17, 2024
The
ability
to
pursue
family
planning
goals
is
integral
gender
equity
in
any
field.
Procedural
specialties
pose
occupational
risks
pregnancy.
As
the
largest
procedural
specialty,
general
surgery
provides
an
opportunity
understand
planning,
workplace
support
for
parenthood,
obstetric
outcomes,
and
impact
of
these
factors
on
workforce
well-being,
equity,
attrition.
Journal of Clinical Medicine,
Journal Year:
2025,
Volume and Issue:
14(4), P. 1390 - 1390
Published: Feb. 19, 2025
Background/Objectives:
The
aim
was
to
develop
a
Japanese
version
of
the
Obstetric
Quality
Recovery-11
questionnaire
(ObsQoR-11J),
assess
its
feasibility,
reliability,
and
validity,
investigate
association
with
postpartum
depression
functionality.
need
for
this
study
is
underscored
by
limited
availability
ObsQoR-11
in
different
languages
lack
documentation
on
associations
early
recovery
mid-term
patient-reported
outcomes.
Methods:
After
translating
ObsQoR-11J
into
Japanese,
138
patients
who
underwent
non-emergent
cesarean
delivery
were
enrolled
study.
scores
evaluated
at
24
h,
3
days,
5
days
post-surgery.
between
functionality,
which
assessed
using
Edinburgh
Postnatal
Depression
Scale
(EPDS)
1
months
12-item
World
Health
Organization
Disability
Assessment
Schedule
(WHODAS)
2.0,
respectively,
three
after
delivery,
evaluated.
Results:
completion
rate
h
97.1%
(134/138),
mean
post-surgery
67.2,
89.0,
96.3,
respectively.
Cronbach's
alpha
0.77,
Spearman
correlation
coefficient
global
health
visual
analog
scale
0.43
(p
=
0.03)
h.
score
any
measurement
point
significantly
associated
EPDS
WHODAS2.0
adjusting
clinically
relevant
factors
(all
p
<
0.05).
Conclusions:
valid
assessment
tool,
are
outcome
measures.
Psychopharmacology,
Journal Year:
2023,
Volume and Issue:
240(9), P. 1841 - 1863
Published: Aug. 11, 2023
Abstract
This
article
describes
the
critical
role
of
neurosteroids
in
postpartum
depression
(PPD)
and
outlines
landmark
pharmacological
journey
brexanolone
as
a
first-in-class
neurosteroid
antidepressant
with
significant
advantages
over
traditional
antidepressants.
PPD
is
neuroendocrine
disorder
that
affects
about
20%
mothers
after
childbirth
characterized
by
symptoms
including
persistent
sadness,
fatigue,
dysphoria,
well
disturbances
cognition,
emotion,
appetite,
sleep.
The
main
pathology
behind
reduction
neurosteroids,
referred
to
withdrawal,
concept
pioneered
our
preclinical
studies.
We
developed
replacement
therapy
(NRT)
rational
approach
for
treating
other
conditions
related
deficiency,
unveiling
power
novel
anxiolytic-antidepressants.
neurosteroid,
(BX),
progesterone-derived
allopregnanolone
rapidly
relieves
anxiety
mood
deficits
activating
GABA-A
receptors,
making
it
transformational
treatment
PPD.
In
2019,
FDA
approved
BX,
an
intravenous
formulation
allopregnanolone,
NRT
treat
clinical
studies,
BX
significantly
improved
within
hours
administration,
tolerable
side
effects
headache,
dizziness,
somnolence.
identified
molecular
mechanism
neuronal
PPD-like
milieu.
involves
activation
both
synaptic
extrasynaptic
which
promote
tonic
inhibition
serve
key
target
conditions.
Neurosteroids
offer
several
antidepressants,
rapid
onset,
unique
mechanism,
lack
tolerance
upon
repeated
use.
Some
limitations
include
aqueous
solubility,
limited
accessibility,
hospitalization
treatment,
oral
product,
serious
adverse
events
at
high
doses.
However,
unmet
need
synthetic
address
this
condition
supersedes
these
limitations.
Recently,
we
hydrophilic
superior
profile
drug
delivery.
Overall,
approval
major
milestone
field
neurotherapeutics,
paving
way
development
depression,
epilepsy,
status
epilepticus.
Graphical
abstract
Journal of Affective Disorders,
Journal Year:
2024,
Volume and Issue:
351, P. 904 - 914
Published: Feb. 5, 2024
Major
depressive
disorder
(MDD)
and
postpartum
depression
(PPD)
are
disabling
conditions.
This
integrated
analysis
of
MDD
PPD
clinical
trials
investigated
the
impact
zuranolone—a
positive
allosteric
modulator
synaptic
extrasynaptic
GABAA
receptors
neuroactive
steroid
under
investigation
for
adults
with
approved
as
an
oral,
once-daily,
14-day
treatment
course
in
US—on
health-related
quality
life,
including
functioning
well-being,
assessed
using
36-item
Short
Form
Health
Survey
V2
(SF-36).
Integrated
data
from
3
(201B,
MOUNTAIN,
WATERFALL)
1
trial
(ROBIN)
individual
SF-36
domains
were
compared
zuranolone
(30-
50-mg)
vs
placebo
at
Day
(D)15
D42.
Comparisons
between
responders
(≥50
%
reduction
baseline
17-item
Hamilton
Depression
Rating
Scale
total
score)
nonresponders
assessed.
Overall,
1003
patients
included
(zuranolone,
n
=
504;
placebo,
499).
Significant
differences
change
(CFB)
to
D15
groups
observed
6/8
domains;
changes
sustained
or
improved
D42,
significant
CFB
all
8
domains.
Zuranolone
had
significantly
higher
scores
D42
(p
<
0.001).
Two
doses
across
populations
2
disease
states
potential
functioning,
comorbidities,
patient
demographics.
All
p-values
presented
nominal.
4
showed
improvements
well-being
Benefits
persisted
after
completion
Journal of Medical Economics,
Journal Year:
2024,
Volume and Issue:
27(1), P. 582 - 595
Published: March 25, 2024
Aims:
Estimate
relative
efficacy
of
zuranolone,
a
novel
oral,
Food
and
Drug
Administration-approved
treatment
for
postpartum
depression
(PPD)
in
adults
vs.
selective
serotonin
reuptake
inhibitors
(SSRIs)
combination
therapies
used
PPD
the
United
States.
Drug Design Development and Therapy,
Journal Year:
2021,
Volume and Issue:
Volume 15, P. 3017 - 3026
Published: July 1, 2021
Objective:
This
paper
reviews
the
current
literature
available
for
efficacy
and
safety
of
allopregnanolone
agonists
discusses
considerations
their
place
in
therapy.
Literature
Search:
A
search
was
conducted
utilizing
PubMed,
clinicaltrials.gov,
manufacturer's
website.
Data
Synthesis:
One
phase
II
trial
two
III
trials
evaluating
brexanolone
were
identified.
Brexanolone
demonstrated
through
significantly
reduced
Hamilton
Depression
Rating
Scale
(HAM-D)
scores
compared
to
placebo
treatment
postpartum
depression
(PPD).
Noted
adverse
effects
somnolence
dizziness,
excessive
sedation,
loss
consciousness.
published
study
interim
results
one
on
zuranolone
included
this
review.
Zuranolone,
an
oral
agonist,
is
given
as
a
single,
14-day
course.
significant
reduction
HAM-D
patients
with
major
depressive
disorder
(MDD)
at
15
28
days
placebo.
Interim
PPD
bipolar
(BPD)
show
promising
reductions
scores.
Adverse
headache.
Place
Therapy:
Allopregnanolone
seem
have
role
when
weighing
quick
onset
action
potential
risks
untreated
PPD.
The
class
medications
limited
by
single
course
indication
may
fit
bridge
maintenance
therapy
selective
serotonin
reuptake
inhibitors
(SSRIs).
Brexanolone,
specifically,
hindered
long
infusion
time,
hospitalization
associated
administration,
risk
evaluation
mitigation
strategy
program.
Zuranolone
also
MDD
or
BPD,
but
more
data
are
needed.
Conclusion:
present
novel
mechanism
disorders.
Clinical
support
PPD,
MDD,
BPD.
Keywords:
postpartum,
bipolar,
brexanolone,
Birth,
Journal Year:
2021,
Volume and Issue:
48(4), P. 524 - 533
Published: June 11, 2021
Abstract
Background
The
COVID‐19
pandemic
forced
hospitals
in
the
United
States
to
adjust
policy
and
procedure
order
provide
safe
care
prevent
spread
of
disease.
At
beginning
pandemic,
media
case
reports
described
pressure
for
medical
interventions,
visitor
restrictions,
separation
from
newborns,
an
increase
patient
demand
community
birth
(home
center).
purpose
this
study
was
describe
experiences
during
centering
birthing
person's
perspective.
Methods
A
survey
e‐mailed
users
Ovia
Pregnancy
app
reaching
a
national
convenience
sample
who
gave
between
March
1,
2020,
June
11,
2020.
Survey
topics
included
location,
Mothers
on
Respect
index,
open‐ended
questions
capturing
perspectives
pandemic's
effect
their
experiences.
Differences
were
assessed
based
state‐level
COVID
rate
by
race.
Content
analysis
performed
analyze
responses.
Results
Respondents
highly
impacted
states
more
frequently
changed
or
considered
changing
location.
Racial
differences
also
found
with
Black
respondents
reporting
significantly
preterm
births
lower
respect
scores
when
compared
White
respondents.
Six
themes
emerged
content
analysis:
Institutional
Policies,
Changes
Care,
Hospital
Staff
Interactions,
Sub‐par
Issues
Support,
Mental
Health
.
Discussion
health
must
continue
adapt
policies
procedures
best
support
patients
pandemic.
address
reality
that
receive
less
respectful
patients.
Journal of Neuroendocrinology,
Journal Year:
2021,
Volume and Issue:
34(2)
Published: July 27, 2021
Postpartum
depression
(PPD)
is
a
common
major
depressive
episode
surrounding
childbirth,
with
estimated
rates
ranging
from
5.5%
to
23.5%
of
all
live
births
across
Europe
and
the
USA
based
on
presence
key
symptoms.
PPD
has
been
associated
significant
impairments
in
both
maternal
functioning
mother-infant
attachment,
these
can
have
lasting
effects
emotional
cognitive
development
children.
Although
precise
pathophysiology
unknown,
preclinical
findings
suggest
that
large
fluctuations
neurosteroid
hormone
levels
induce
physiological
plasticity
expression
functional
GABAA
receptors
during
pregnancy
postpartum
period,
deficits
this
may
underpin
biological
mechanism
contributes
manifestation
Here,
we
review
controlled
clinical
trials
date
assessed
efficacy
pharmacological
treatments
for
PPD,
including
oestradiol,
selective
serotonin
reuptake
inhibitors,
brexanolone
(an
iv
formulation
allopregnanolone)
an
investigational
neuroactive
steroid
positive
allosteric
modulator,
zuranolone.
Coupled
GABAergic
implicated
disorder,
highlight
not
only
potential
role
receptor
but
also
novel
therapeutic
approach
using
modulators
targeting
transmission
treat
women
affected
by
PPD.