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.
Journal of Women s Health,
Journal Year:
2020,
Volume and Issue:
30(2), P. 154 - 159
Published: Nov. 6, 2020
Perinatal
depression
(PND)
is
a
major
depressive
episode
during
pregnancy
or
within
4
weeks
after
childbirth
up
to
year.
Risk
factors
for
PND
include
stressful
life
events,
history
of
depression,
poor
social
support,
unplanned
and
unwanted
pregnancies,
relationship
quality,
current
previous
abuse,
low
socioeconomic
status.
This
mental
disorder
has
been
shown
have
negative
effects
on
mothers'
quality
their
intimate
relationships,
birth
outcomes,
breastfeeding
likelihood,
as
well
long-term
children's
cognitive
emotional
development.
To
date,
no
nationally
representative
study
examined
whether
there
are
and/or
racial/ethnic
differences
in
PND.
discusses
the
prevalence
risk
PND,
its
health
consequences
mothers
children,
reasons
underreporting
undertreatment,
evidence
different
screening
instruments
treatment
options,
existing
supportive
policies
address
this
United
States.
We
conclude
with
outlining
next
steps
addressing
gaps
literature
JAMA Psychiatry,
Journal Year:
2021,
Volume and Issue:
78(9), P. 951 - 951
Published: June 30, 2021
Postpartum
depression
(PPD)
is
one
of
the
most
common
medical
complications
during
and
after
pregnancy,
negatively
affecting
both
mother
child.To
demonstrate
efficacy
safety
zuranolone,
a
neuroactive
steroid
γ-aminobutyric
acid
receptor-positive
allosteric
modulator,
in
PPD.This
phase
3,
double-blind,
randomized,
outpatient,
placebo-controlled
clinical
trial
was
conducted
between
January
2017
December
2018
27
enrolling
US
sites.
Participant
were
women
aged
18
to
45
years,
6
months
or
fewer
post
partum,
with
PPD
(major
depressive
episode
beginning
third
trimester
≤4
weeks
postdelivery),
baseline
17-item
Hamilton
Rating
Scale
for
Depression
(HAMD-17)
score
26
higher.
Analysis
intention
treat
began
ended
March
2019.Randomization
1:1
placebo:zuranolone,
30
mg,
administered
orally
each
evening
2
weeks.Primary
end
point
change
from
HAMD-17
zuranolone
vs
placebo
at
day
15.
Secondary
points
included
changes
total
other
time
points,
response
(≥50%
reduction)
remission
(score
≤7)
rates,
Montgomery-Åsberg
score,
Anxiety
score.
Safety
assessed
by
adverse
events
assessments.Of
153
randomized
patients,
set
comprised
150
patients
(mean
[SD]
age,
28.3
[5.4]
years),
148
(98.7%)
completed
treatment.
A
76
placebo,
77
mg.
Zuranolone
demonstrated
significant
15
improvements
(-17.8
-13.6;
difference,
-4.2;
95%
CI,
-6.9
-1.5;
P
=
.003).
Sustained
differences
scores
favoring
observed
3
(difference,
-2.7;
-5.1
-0.3;
.03)
through
-4.1;
-6.7
-1.4;
(odds
ratio,
2.63;
1.34-5.16;
.005),
2.53;
1.24-5.17;
.01),
-4.6;
-8.3
-0.8;
.02),
-3.9;
-1.1;
.006).
One
patient
per
group
experienced
serious
event
(confusional
state
pancreatitis
group).
discontinued
because
an
none
placebo.In
this
trial,
improved
core
symptoms
as
measured
generally
well
tolerated,
supporting
further
development
treatment
PPD.ClinicalTrials.gov
Identifier:
NCT02978326.
American Journal of Obstetrics and Gynecology,
Journal Year:
2020,
Volume and Issue:
224(4), P. 384.e1 - 384.e11
Published: Oct. 8, 2020
Randomized
controlled
trials
document
the
safety
and
efficacy
of
reduced
frequency
prenatal
visit
schedules
virtual
visits,
but
real-world
data
are
lacking.
Our
institution
created
a
care
delivery
model
incorporating
these
alternative
approaches
to
continue
safely
providing
during
coronavirus
disease
2019
pandemic.To
evaluate
institutional-level
adoption
patient
provider
experiences
with
model.We
conducted
single-site
evaluation
schedule
visits
deployed
at
suburban
academic
on
March
20,
2020.
We
used
electronic
health
record
institution-level
adoption,
defined
as
changes
in
overall
proportion
3
months
before
after
implementation.
To
experience
model,
we
an
online
survey
all
pregnant
patients
(>20
weeks'
gestation)
providers
May
Of
note,
domains
were
evaluated:
(1)
access,
(2)
quality
safety,
(3)
satisfaction.
Quantitative
analyzed
basic
descriptive
statistics.
Free-text
responses
coded
by
elucidated
drivers
positive
negative
experiences.After
average
weekly
volume
fell
16.1%,
from
898
761
visits;
virtually
increased
10.8%
(97
898)
43.3%
(330
761);
no-show
rate
remained
stable
(preimplementation,
4.3%;
postimplementation,
4.2%).
those
eligible,
74.8%
(77
103)
15.0%
(253
1690)
participated
surveys.
Patient
respondents
largely
white
(180
253;
71.1%)
privately
insured
(199
78.7%),
reflecting
study
site
population.
The
rates
chronic
conditions
pregnancy
complications
also
differed
national
prevalence.
Provider
predominantly
(44
66;
66.7%)
female
(50
75.8%).
Most
almost
reported
that
improved
access
(patients,
174
253
[68.8%];
providers,
74
77
[96.1%]).
More
than
half
124
[53.3%];
41
[62.1%])
believed
safe.
Nearly
home
blood
pressure
cuffs
important
for
213
231
[92.2%];
63
66
[95.5%]).
satisfaction
196
[77.5%];
64
[83.1%]).
In
free-text
responses,
similar
included
perceived
through
decreased
barriers
(eg,
transportation,
childcare),
high
low-risk
pandemic,
better
counseling.
Perceived
less
common.
These
concerns
unequal
could
deepen
existing
maternity
inequities,
lack
devices
cuffs)
would
affect
dissatisfaction
poor
patient-provider
continuity
inadequate
expectation
setting
experience.Reduced
rapidly
integrated
into
care,
many
providers.
Future
research
is
needed
understand
outcomes
associated
across
more
diverse
populations
outside
pandemic
inform
broader
policy
decisions.
JAMA,
Journal Year:
2023,
Volume and Issue:
329(23), P. 2057 - 2057
Published: June 20, 2023
Importance
Major
depressive
disorder
(MDD),
a
common
mental
in
the
US,
may
have
substantial
impact
on
lives
of
affected
individuals.
If
left
untreated,
MDD
can
interfere
with
daily
functioning
and
also
be
associated
an
increased
risk
cardiovascular
events,
exacerbation
comorbid
conditions,
or
mortality.
Objective
The
US
Preventive
Services
Task
Force
(USPSTF)
commissioned
systematic
review
to
evaluate
benefits
harms
screening,
accuracy
treatment
suicide
asymptomatic
adults
that
would
applicable
primary
care
settings.
Population
Asymptomatic
19
years
older,
including
pregnant
postpartum
persons.
Older
are
defined
as
those
65
older.
Evidence
Assessment
USPSTF
concludes
moderate
certainty
screening
for
adults,
persons
older
has
net
benefit.
evidence
is
insufficient
benefit
adults.
Recommendation
recommends
depression
adult
population,
(B
recommendation)
current
assess
balance
(I
statement)
American Journal of Psychiatry,
Journal Year:
2023,
Volume and Issue:
180(9), P. 668 - 675
Published: July 26, 2023
Postpartum
depression
(PPD)
is
a
common
perinatal
complication
with
adverse
maternal
and
infant
outcomes.
This
study
investigated
the
efficacy
safety
of
zuranolone,
positive
allosteric
modulator
synaptic
extrasynaptic
GABAA
receptors
neuroactive
steroid,
as
an
oral,
once-daily,
14-day
treatment
course
for
patients
severe
PPD.In
this
double-blind
phase
3
trial,
women
PPD
were
randomized
in
1:1
ratio
to
receive
zuranolone
50
mg/day
or
placebo
14
days.
The
primary
endpoint
was
change
from
baseline
total
score
on
17-item
Hamilton
Depression
Rating
Scale
(HAM-D)
at
day
15;
key
secondary
endpoints
HAM-D
days
3,
28,
45
Clinical
Global
Impressions
severity
(CGI-S)
15.
Adverse
events
monitored.Among
196
(zuranolone,
N=98;
placebo,
N=98),
170
(86.7%)
completed
45-day
study.
Treatment
compared
resulted
statistically
significant
improvement
depressive
symptoms
15
(least
squares
mean
[LSM]
score,
-15.6
vs.
-11.6;
LSM
difference,
-4.0,
95%
CI=-6.3,
-1.7);
also
reported
45.
CGI-S
significantly
improved
placebo.
most
(≥10%)
somnolence,
dizziness,
sedation.
No
loss
consciousness,
withdrawal
symptoms,
increased
suicidal
ideation
behavior
observed.In
demonstrated
improvements
generally
well
tolerated,
supporting
potential
novel,
rapid-acting
oral
PPD.
Cureus,
Journal Year:
2023,
Volume and Issue:
unknown
Published: July 4, 2023
Postpartum
depression
(PPD)
is
a
common
and
debilitating
mental
health
condition
affecting
many
mothers
worldwide.
This
review
article
aims
to
explore
the
complex
effects
of
PPD
on
infants,
focusing
maternal
care.
The
transition
motherhood
critical
period
characterized
by
numerous
physical,
psychological,
social
changes,
making
women
vulnerable
onset
PPD.
Consequently,
can
significantly
impact
mother's
ability
provide
optimal
care
for
her
infant,
leading
potential
adverse
consequences
both
parties.
synthesizes
existing
research
literature
topic,
encompassing
studies
from
various
disciplines,
including
psychology,
psychiatry,
obstetrics,
pediatrics.
It
begins
providing
an
overview
prevalence
risk
factors
associated
with
PPD,
emphasizing
importance
early
detection
intervention.
caregiving
behaviors,
such
as
bonding,
sensitivity,
responsiveness,
then
examined,
highlighting
disruptions
in
mother-infant
relationship.
Furthermore,
delves
into
impaired
infant
development,
emotional,
cognitive,
domains.
Several
contributing
interplay
between
are
discussed,
hormonal
psychosocial
stressors,
influence
support
networks.
also
addresses
bidirectional
nature
relationship,
whereby
characteristics
behaviors
exacerbate
or
mitigate
Moreover,
explores
role
healthcare
providers
implementing
effective
screening,
assessment,
treatment
strategies
promote
maternal-infant
outcomes.
By
consolidating
current
knowledge
this
provides
valuable
insights
multifaceted
infants.
Recognizing
significance
understanding
mechanisms
through
which
disrupts
it
inform
development
targeted
interventions
detection,
treatment,
supportive
experiencing
Ultimately,
improving
enhancing
relationships
yield
long-term
positive
mothers'
infants'
well-being
development.
Children,
Journal Year:
2022,
Volume and Issue:
9(3), P. 394 - 394
Published: March 10, 2022
Background:
U.S.
maternal
and
infant
mortality
rates
constitute
an
important
public
health
problem,
because
these
surpass
those
in
developed
countries
are
characterized
by
stark
disparities
for
racial/ethnic
minorities,
rural
residents,
individuals
with
less
privileged
socioeconomic
status
due
to
social
determinants
of
(SDoH).
Methods:
A
critical
review
the
literature
was
performed
determine
multilevel
SDoH
factors
leading
a
life
course
lens.
Results:
Black
mothers
infants
fared
worst
terms
rates,
likely
accumulation
experienced
as
result
structural
racism
across
course.
Upstream
contributors
mortality.
More
research
is
needed
on
effectiveness
continuous
quality
improvement
initiatives
maternal–infant
dyad,
expanding
programs
such
paid
maternity
leave,
quality,
stable
affordable
housing,
safety-nets
(Medicaid,
CHIP,
WIC),
reducing
Finally,
it
address
gaps
individual,
interpersonal,
community,
societal
factors,
they
affect
related
disparities.
Conclusion:
Key
at
multiple
levels
health.
These
shape
perpetuate
lifespan
implicated
Journal of Affective Disorders,
Journal Year:
2022,
Volume and Issue:
320, P. 353 - 359
Published: Sept. 30, 2022
Brexanolone
is
currently
the
only
treatment
specifically
approved
for
postpartum
depression
(PPD)
in
United
States,
based
on
results
from
one
Phase
2
and
two
3
double-blind,
randomized,
controlled
trials
HUMMINGBIRD
program.Adults
with
PPD
randomized
to
a
60-h
infusion
of
brexanolone
90
μg/kg/h
(BRX90)
or
placebo
were
included
these
post
hoc
analyses.
Data
change
baseline
(CFB)
17-item
Hamilton
Rating
Scale
Depression
(HAMD-17)
total
score,
HAMD-17
Anxiety/Somatization
Insomnia
subscales,
Clinical
Global
Impression
Improvement
(CGI-I)
scale
pooled.
Response
rates
(≥50
%
reduction
baseline)
CGI-I
(score
1
2)
scales
time
response
analyzed.Patients
receiving
BRX90
(n
=
102)
versus
107)
achieved
more
rapid
(median,
24
vs
36
h;
p
0.0265),
an
Hour-60
cumulative
rate
81.4
67.3
%;
similar
0.0058),
61.7
%.
CFB
subscales
also
favored
placebo,
starting
at
Hour
through
Day
30
(all
<
0.05),
both
higher
BRX90.The
study
was
not
powered
assess
exploratory
outcomes.Brexanolone
associated
improvement
depressive
symptoms
anxiety
insomnia
compared
women
PPD.
These
data
continue
support
use
treat
adults
The Lancet Regional Health - Americas,
Journal Year:
2023,
Volume and Issue:
21, P. 100462 - 100462
Published: March 6, 2023
Little
research
exists
regarding
the
relationships
between
green
space
and
postpartum
depression
(PPD).
We
aimed
to
investigate
PPD
exposure,
mediating
role
of
physical
activity
(PA).
Clinical
data
were
obtained
from
Kaiser
Permanente
Southern
California
electronic
health
records
in
2008–2018.
ascertainment
was
based
on
both
diagnostic
codes
prescription
medications.
Maternal
residential
exposures
assessed
using
street
view-based
measures
vegetation
types
(i.e.,
tree,
low-lying
vegetation,
grass),
satellite-based
[i.e.,
Normalized
Difference
Vegetation
Index
(NDVI),
land-cover
space,
tree
canopy
cover],
proximity
nearest
park.
Multilevel
logistic
regression
applied
estimate
association
PPD.
A
causal
mediation
analysis
performed
proportion
mediated
by
PA
during
pregnancy
total
effects
In
total,
we
included
415,020
participants
(30.2
±
5.8
years)
with
43,399
(10.5%)
cases.
Hispanic
mothers
accounted
for
about
half
population.
reduced
risk
associated
exposure
street-view
measure
[500
m
buffer,
adjusted
odds
ratio
(OR)
per
interquartile
range:
0.98,
95%
CI:
0.97–0.99],
but
not
NDVI,
greenness,
or
a
Compared
other
coverage
showed
stronger
protective
(500
OR
=
0.97–0.99).
The
proportions
attributable
ranged
2.7%
7.2%
across
indicators.
Street
decreased
observed
primarily
due
increased
coverage,
rather
than
grass.
Increased
plausible
pathway
linking
lower
National
Institute
Environmental
Health
Sciences
(NIEHS;
R01ES030353).
Health Affairs,
Journal Year:
2024,
Volume and Issue:
43(4), P. 486 - 495
Published: April 1, 2024
Understanding
whether
racial
and
ethnic
inequities
exist
along
the
postpartum
mental
health
care
continuum
is
vital
because
inequitable
identification
of
depression
can
lead
to
referral
receipt
care.
We
aimed
expand
on
existing
cross-sectional
single-state
data
documenting
potential
disparities
in
Using
early
(from
two
six
months)
late
twelve
fourteen
survey
from
seven
US
jurisdictions,
we
documented
patterns
depressive
symptoms,
perinatal
mood
anxiety
disorder
(PMAD)
diagnosis,
overall
by
identity.
Of
4,542
people
who
delivered
live
births
2020,
11.8
percent
reported
symptoms.
Among
sample
with
these
only
25.4
receiving
a
PMAD
52.8
some
form
There
were
no
significant
differences
diagnosis
race
ethnicity.
Respondents
identifying
as
Asian;
Native
Hawaiian
or
Pacific
Islander;
Southwest
Asian,
Middle
Eastern,
North
African;
Hispanic;
non-Hispanic
Black
significantly
less
likely
than
White
respondents
receive
care,
demonstrating
stark
management
Policies
mandating
reimbursing
universal
screening,
facilitating
connection
reducing
insurance
coverage
gaps,
enhancing
clinician
training
culturally
responsive
may
promote
equitable