DOI: 10.1111/bdi.
13481
ORIGINAL ARTICLE
Mood stabilizers for treatment of bipolar disorder in pregnancy
and impact on neonatal outcomes
Nalinoë Kernizan1,2,a | Alicia Forinash1,2 | Abigail Yancey1,2 | Samuel Kruger3 |
Niraj R. Chavan4 | Katherine Mathews5
1
University Health Sciences and
Pharmacy—St. Louis College of Pharmacy, Abstract
St Louis, Missouri, USA
Introduction: Untreated bipolar disorder in pregnancy is associated with adverse
2
SSM Health St. Mary's Hospital Center, St
Louis, Missouri, USA
maternal and neonatal outcomes. Despite advances in clinical management, there is
3
College of Public Health and Social concern among obstetric providers and patients about the safety of pharmacological
Justice, Saint Louis University, St Louis, agents for the treatment of bipolar disorder in pregnancy. Recent studies have shown
Missouri, USA
4 atypical antipsychotics and lamotrigine to have a favorable safety profile; however,
Division of Maternal Fetal Medicine,
Department of Obstetrics, Gynecology & little information is published on lurasidone.
Women's Health, Saint Louis University, St
Objectives: The objective of this retrospective chart review was to evaluate preg-
Louis, Missouri, USA
5
Department of Obstetrics, Gynecology & nancy and neonatal outcomes in obstetric patients with bipolar disorder who are un-
Women's Health, Saint Louis University, St treated, compared to those treated with lurasidone, other atypical antipsychotics, and
Louis, Missouri, USA
lamotrigine at a tertiary teaching institution.
Correspondence Methods: This retrospective cohort study included neonates whose mothers had a
Alicia Forinash, University Health Sciences
and Pharmacy—St. Louis College of diagnosis of bipolar disorder and were referred to the Maternal & Fetal Care Clinic
Pharmacy, St Louis, MI, USA. with two documented visits after January 1, 2014, with delivery by October 31, 2017,
Email: [email protected]
within an SSM health-system hospital.
Results: In this study, women with untreated bipolar disorder (not on any mood stabi-
lizer) in pregnancy had significantly higher rates of premature delivery and low birth
weight compared to women on mood stabilizers of lamotrigine, lurasidone, and other
atypical antipsychotics. No difference was observed for pregnancy or neonatal out-
comes between patients taking any of the mood stabilizers.
Conclusions: This study suggests that the use of lurasidone, other atypical antipsy-
chotics, and lamotrigine have better neonatal outcomes than untreated bipolar disor-
der in pregnancy.
KEYWORDS
bipolar, mood stabilizer, obstetrics, pregnancy
a
PGY2 resident at 1,2 during the project and current position at the Vanguard Medical Group.
© 2024 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.
Bipolar Disorders. 2024;00:1–6. wileyonlinelibrary.com/journal/bdi | 1
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2 KERNIZAN et al.
1 | I NTRO D U C TI O N disorder compared to patients treated with lurasidone, other atypi-
cal antipsychotics, and lamotrigine at a tertiary teaching institution.
Bipolar disorder is a psychiatric condition that causes dramatic
fluctuations in mood, varying between euthymic, depressive,
manic, and mixed episodes. The lifetime prevalence of bipolar dis- 2 | PATI E NT S A N D M E TH O DS
1
order in the United States is 4.4%. Most women are diagnosed
between 18 and 30 years of age which overlaps with their peak re- 2.1 | Study design
productive years. 2 Uncontrolled bipolar disorder during pregnancy
is associated with a 25%–50% increased risk for postpartum psy- The maternal and fetal care center is an interprofessional teaching
3
chosis. Additionally, worsening mood postpartum, fetal growth clinic for a local university obstetrics and gynecology residency and
restriction, preterm birth, adverse neurodevelopmental outcomes, maternal fetal medicine fellowship programs that provides both low-
cesarean delivery, instrumental delivery, non-spontaneous start and high-risk obstetric care. Additionally, high-risk patients can be
of delivery, microcephaly, and neonatal hypoglycemia are also as- referred for transfer of care, co-management of care, or for a consul-
sociated with untreated bipolar during pregnancy. 3,4 In fact, one tation by their outside physicians at any point during the pregnancy.
study found that the risk for preterm delivery increases by 50% This retrospective chart review was approved by the institu-
for patients with bipolar disorders during pregnancy regardless if tional review boards (Saint Louis University and St. Louis College
the patient was treated or not. Despite these risks, only a propor- of Pharmacy) and analyzed clinical data extracted from the elec-
tion of pregnant patients continue psychiatric medications during tronic medical records of mothers and neonates who were born to
pregnancy, which was seen in one study where only 15.4% of pregnant women who were at least 14 years of age with a diagnosis
women continued filling atypical antipsychotics throughout preg- of bipolar disorder and had at least two prenatal care visits at the
nancy who had filled prior to last menstrual period. 5 Discontinuing Maternal and Fetal Care Center at SSM Health St. Mary's Hospital
therapy before or during pregnancy resulted in a 71% chance of at Center after January 1, 2014, with delivery by October 31, 2017.
least one mood disorder recurrence during pregnancy, with 47% Mothers were identified by two methods: ICD-9 and ICD-10 codes
occurring during the first trimester of pregnancy. 6 The American for bipolar disorder diagnosis and via medication reports of pregnant
College of Obstetricians and Gynecologists recommends against women who were prescribed antidepressants, lamotrigine, and any
discontinuing mood stabilizers except for valproic acid during atypical antipsychotics. Neonates were identified via their mothers
pregnancy. Several clinical practice guidelines recommend mood based on chart review. All eligible mother–infant pairs were included
stabilizers as first-line treatment for bipolar disorder during preg- in the analysis. Women using a combination of multiple mood sta-
nancy, including the use of the antiseizure medication lamotrigine bilizers or switching mood stabilizer medications during pregnancy
7–9
and atypical antipsychotics. Given that 2018 CANMAT guide- were excluded (n = 22 pregnancies). Neonates born outside the SSM
lines note the list of medications that are defined as mood stabi- Health System whose neonatal outcomes were not available were
lizers is inconsistent, we are using mood stabilizers in this study to excluded. For the purposes of this project, we considered lithium,
include lithium, antiepileptic medications for bipolar disorder such antiepileptics, and atypical antipsychotics as mood stabilizers.
9
as lamotrigine, and atypical antipsychotics. Although lamotrigine
has not been associated with malformations during pregnancy, it is
not a recommended treatment for acute mania, and it has a slower 2.2 | Data collection
titration compared to other therapies, both of which should be
considered when choosing appropriate therapy.9,10 A recent pub- Pertinent neonatal information was collected from a review of
lication evaluating over 21,000 atypical antipsychotics exposures neonatal electronic medical records and included gender, delivery
in pregnancy only found an increased risk of oral clefts with olan- type, birth weight, length, head circumference, Apgar Score at 1 and
zapine; unfortunately, lurasidone pregnancy exposures were not 5 min, presence and type of anatomical malformation, and neonatal
11
captured in this study. To date, lurasidone only has two publica- intensive care unit (NICU) admission. Maternal information collected
tions evaluating use in pregnancy.12,13 included bipolar treatment regimens at the first visit, throughout
At our institution, lurasidone became the preferred atypical an- pregnancy, and at delivery and illicit drug use by the mother during
tipsychotic for use in pregnancy in 2013 due to the previously used pregnancy.
14
Food and Drug Association (FDA) pregnancy category rating of B. Statistical analysis was performed using SPSS. Two-sample in-
Although this system is no longer the current FDA system for eval- dependent t-test was performed for each continuous outcome vari-
uating safety in pregnancy, it was still utilized when lurasidone was able; Fisher's exact test was used for the ordinal outcomes and a
added to the formulary and during the study period. During this time, Wilcoxon rank test was used for Apgar scores at 1-and 5-min. Mood
lurasidone was the only mood stabilizer with a category B pregnancy stabilizer usage was further stratified into three categories (lurasi-
rating despite not having any human pregnancy safety data.14 The done, lamotrigine, and other atypical antipsychotics) and a one-way
purpose of this retrospective chart review was to evaluate preg- ANOVA was performed for the continuous outcome variables being
nancy and neonatal outcomes in patients with untreated bipolar compared across these three groups. Because no difference was
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KERNIZAN et al. 3
observed between groups, no correction factors were needed for ventricle with subpulmonic ventricular septal defect) occurred in a
performing pairwise comparisons. Fisher's exact test was used for patient exposed to quetiapine; unfortunately, the gestational age at
comparing the ordinal outcomes across these three groups. Due medication initiation was missing. One fetal demise was observed in
to there being more than two groups, Friedman's test was used the untreated group and one in an olanzapine-exposed infant.
for APGAR scores at 1 and 5 min. Statistical significance was set at
p ≤ 0.05. The STROBE checklist was reviewed.
4 | DISCUSSION
3 | R E S U LT S In this study, the rates of preterm delivery and low birth weight were
higher among infants born to mothers with untreated bipolar dis-
Upon chart review, there were 178 women included with a total of order compared to those treated with mood stabilizers prenatally.
192 pregnancies and 198 infants. Overall population demographics These findings suggest that mood stabilizer administration dur-
are in Table 1. Of the 198 infants born, 49.0% (n = 97) were female. ing pregnancy for the treatment of bipolar disorder is not associ-
Fifty-nine infants (29.8%) were exposed to mood stabilizers at some ated with an increase in adverse pregnancy or neonatal outcomes.
point during pregnancy. Patients receiving mood stabilizers had sig- Neonates from pregnancies that remained untreated with mood
nificantly lower rates of preterm delivery and significantly higher stabilizers had the lowest average gestational age at birth, head cir-
birth weights, but no difference was observed for mean gestational cumference, and birth weight compared to those exposed to mood
age of delivery, length, head circumference, C-
section delivery, stabilizers prenatally but only gestational age at delivery and birth
NICU admission rates, or Apgar scores (Table 2). When compar- weight were significant. Our results are in consonance with previous
ing only infants born full term (defined as ≥37 weeks gestation), no findings indicating that treatment of bipolar disorder in pregnancy
significant differences were observed among those born to treated is associated with more favorable neonatal outcomes as compared
versus untreated mothers (Table 3). No significant differences were to untreated disease and further echo other similar studies indicat-
noted in clinical outcomes among neonates born to pregnant women ing that anti-psychotic treatment of bipolar disorder in pregnancy is
receiving lurasidone, lamotrigine, or other atypical antipsychotics not associated with adverse prenatal outcomes.4,16,17 In comparison,
(Table 4). Similarly, in those delivered at 37 weeks gestation or later, Wang et al. also found that there were no increased risks of preterm
we noted no significant difference in clinical outcomes. (Table 5). birth and small for gestational age infants in unexposed neonates
No significant difference was found in the malformation rates from pregnancies affected by psychiatric disorders.17
among neonates exposed to no medications compared to those ex- Importantly, it has been shown that most women stop taking
posed to lamotrigine, lurasidone, or other atypical antipsychotics. prescribed psychiatric medications once they find out about their
Nine infants of the untreated group had malformations, compared pregnancy and that medical professionals who are not familiar with
to only two who were exposed. Of the exposed, one malformation perinatal mental health services are typically uncomfortable with
(gastroschisis) was observed in the lamotrigine group; however, caring for pregnant women with bipolar disorder.18 Hence, our study
the exposure to lamotrigine occurred late in third trimester, after adds critical value indicating that treatment of bipolar disorder in
35 weeks of gestation, well after formation as development of the pregnancy is associated with overall better neonatal outcomes in
ventral body wall is fully completed typically 8–10 weeks after fer- pregnancy as compared to untreated pregnancies. In our study lur-
tilization.15 Thus, the malformation is unlikely to be caused by la- asidone was noted to have a safe neonatal profile. Although there is
motrigine exposure. The other malformation (double outlet right very limited data on lurasidone use in pregnancy, available data sup-
port our findings and were echoed by Montiel et al. in their research
TA B L E 1 Baseline demographics of entire study cohort. which did not show adverse neonatal outcomes with lurasidone use
in pregnancy.12 Similarly, data from the National Pregnancy Registry
Number of included women/pregnancies/ 178/192/198
for Psychiatric Medications reported 134 pregnancy exposures to
infants
lurasidone. Lurasidone was associated with an absolute risk of mal-
Singleton births 96.88% (n = 186) of
pregnancies formations of 2.19%, which is within the background rate for mal-
Female infants 49.0% (n = 97) of
formations of 3–5%.19 No difference was observed in malformations
infants between lurasidone and quetiapine.13 This observation improves
Premature delivery 25.25% (n = 50) of confidence that lurasidone is an acceptable option in the armamen-
infants tarium for bipolar disorder treatment during pregnancy with minimal
Cesarean deliveries 34.9% (n = 67) of risks to a fetus.
pregnancies There are several strengths of our study. Although other lit-
Neonatal intensive care unit admission rate 27.27% (n = 54) of erature has documented pregnancy outcomes for lamotrigine
infants and other atypical antipsychotics, this study contributes to the
Fetal demise/stillbirth 2.6% (n = 5) of limited pregnancy data for lurasidone during pregnancy. In our
pregnancies
study, lurasidone has similar outcomes to both lamotrigine and
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4 KERNIZAN et al.
TA B L E 2 Neonatal outcomes based on
No mood Any mood
mood stabilizer status (yes/no).
stabilizer (N = 139) stabilizer (N = 59)
mean ± SD/N(%) mean ± SD/N (%) p-value
Gestational age at delivery (weeks) 37.47 (SD ± 3.04) 38.13 (SD ± 2.98) 0.161
Preterm delivery 42 (30.3%) 8 (13.6%) 0.048*
Birth weight (kg) 2.83 (SD ± 0.75) 3.06 (SD ± 0.57) 0.045*
Length (in) 19.13 (SD ± 1.87) 19.46 (SD ± 1.20) 0.205
Head circumference (cm) 12.97 (SD ± 1.36) 13.28 (SD ± 0.85) 0.113
C-section delivery 47 (33.8%) 20 (33.9%) 0.999
NICU admission 38 (27.3%) 15 (25.4%) 0.863
APGAR 1 min (median, IQR) 8, (6–8) 8, (8, 9) 0.821
APGAR 5 min (median, IQR) 9, (8, 9) 9, (9) 0.716
Abbreviation: NICU, neonatal intensive care unit.
*p < 0.05.
TA B L E 3 Neonatal outcomes based
No mood ANY mood
on mood stabilizer status (Yes/No) for full
stabilizer (N = 97) stabilizer (N = 48)
term deliveries (gestational age at delivery
Mean ± SD/N(%) Mean ± SD/N (%) p-value
≥37 weeks).
Gestational age at delivery (weeks) 39.00 (SD ± 1.00) 39.02 (SD ± 1.12) 0.928
Birth weight (kg) 3.14 (SD ± 0.50) 3.17 (SD ± 0.49) 0.692
Length (in) 19.82 (SD ± 1.05) 19.77 (SD ± 0.83) 0.790
Head circumference (cm) 13.28 (SD ± 0.79) 13.41 (SD ± 0.78) 0.373
C-section delivery 27 (27.8%) 17 (35.4%) 0.443
NICU admission 19 (19.6%) 10 (20.8%) 0.999
APGAR 1 min (median, IQR) 8, (8, 9) 8, (8, 9) 0.091
APGAR 5 min (median, IQR) 9, (9) 9, (9) 0.157
Abbreviation: NICU, neonatal intensive care unit.
TA B L E 4 Neonatal Outcomes Based on Type of Mood Stabilizer Prescribed.
Other atypical
Lurasidone monotherapy Lamotrigine monotherapy antipsychotic a (N = 21)
(N = 25) Mean ± SD/N (%) (N = 13) Mean ± SD/N (%) Mean ± SD/N (%) p-value
Gestational age at delivery 38.16 (SD ± 2.59) 38.51 (SD ± 1.39) 37.86 (SD ± 4.03) 0.752
(weeks)
Preterm delivery 4 (16.0%) 2 (15.4%) 3 (14.3%) 0.999
Birth weight (kg) 3.00 (SD ± 0.71) 3.04 (SD ± 0.43) 3.14 (SD ± 0.45) 0.659
Length (in) 19.42 (SD ± 1.45) 19.61 (SD ± 0.43) 19.42 (SD ± 0.95) 0.429
Head circumference (cm) 13.20 (SD ± 0.96) 13.07 (SD ± 0.69) 13.52 (SD ± 0.79) 0.800
C-Section delivery 8 (32.0%) 4 (30.8%) 8 (38.1%) 0.469
NICU admission 6 (24.0%) 4 (30.8%) 5 (23.8%) 0.580
APGAR 1 min (median, IQR) 8 (8, 9) 8 (8) 8 (7–9) 0.500
APGAR 5 min (median, IQR) 9 (9) 9 (9) 9 (9) 0.999
Abbreviation: NICU, neonatal intensive care unit.
a
Other atypical antipsychotics include aripiprazole, olanzapine, quetiapine, risperidone, ziprasidone.
atypical antipsychotics. This study also represents pregnancy study, this study is subject to inconsistencies in clinical docu-
outcomes from real-
world management of bipolar disorders mentation. Additionally, medication adherence was not assessed,
during pregnancy. Although this study adds to the literature, es- so we are unable to verify if patients were refilling the medica-
pecially with lurasidone use during pregnancy, there are some tions. However, progress notes were reviewed to identify if the
limitations to consider. As with any retrospective chart review patient reported continuing or stopping the medication. Finally,
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KERNIZAN et al. 5
TA B L E 5 Neonatal outcomes based on type of mood stabilizer prescribed for full term deliveries (gestational age at delivery ≥37 weeks).
Other atypical
Lurasidone monotherapy Lamotrigine monotherapy antipsychoticsa (N = 22)
(N = 20) Mean ± SD / N (%) (N = 6) Mean ± SD / N (%) Mean ± SD/N (%) p-value
Gestational age at delivery (weeks) 39.12 (SD ± 1.32) 39.20 (SD ± 1.45) 38.88 (SD ± 0.84) 0.733
Birth weight (kg) 3.21 (SD ± 0.59) 3.27 (SD ± 0.41) 3.12 (SD ± 0.42) 0.746
Length (in) 19.89 (SD ± 0.83) 20.06 (SD ± 0.62) 19.59 (SD ± 0.88) 0.347
Head Circumference (cm) 13.43 (SD ± 0.82) 13.32 (SD ± 0.55) 13.41 (SD ± 0.83) 0.960
C-section delivery 7 (35.0%) 1 (16.7%) 9 (40.9%) 0.591
NICU admission 3 (15.0%) 2 (33.3%) 5 (22.7%) 0.620
APGAR 1 min (median, IQR) 8, (8, 9) 8, (8) 8, (8, 9) 0.852
APGAR 5 min (median, IQR) 9, (9) 9, (9) 9, (9) 0.999
Abbreviation: NICU, neonatal intensive care unit.
a
Other atypical antipsychotics include aripiprazole, olanzapine, quetiapine, risperidone, ziprasidone.
confounders such as control of bipolar disorder, other mater- and postpartum. Clinical practice guideline No. 5. Obstet Gynecol.
nal comorbidities, other medications, and substance use by the 2023;141:1262-1288.
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mother could have affected the results.
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ties from Wolters Kluwer and her spouse is an employee of Bayer, cglclefindmkaj/https://psychiatryonline.org/p b/assets/r aw/sitew
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DATA AVA I L A B I L I T Y S TAT E M E N T
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The data that support the findings of this study are available from tients with bipolar disorder. Bipolar Disord. 2018;20:97-170.
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lamotrigine: a systematic review and meta- analysis. CNS Drugs.
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