Clinical trial NCT00585702: Antimanic Drug Use in Pregnancy
Official title: Antimanic Drug Use in Pregnancy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Bipolar Disorder
Pregnancy
Keywords: Bipolar Disorder
Pregnancy
Infant Development
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2008-01-03
Enrollment: 201
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Age 18 or older Pregnant at 20 weeks or more English-speaking DSM-IV diagnosis of BP, any subtype

Brief summary: The purpose of this study is to learn about the effects of bipolar disorder or the use of antimanic medications on the mother's health and wellbeing during pregnancy and for the first postpartum year. Infant health and development are also assessed during the first year. Participation in the study includes 7 study visits, three in pregnancy and four postpartum.


Eligibility criteria: Inclusion Criteria for Bipolar Subjects:

* Age 18 or older
* Pregnant at 20 weeks or more
* Women must receive OB care
* English-speaking
* DSM-IV diagnosis of BP, any subtype

Inclusion Criteria for non-Bipolar Control Subject:

* Age 18 or older
* Pregnant at 20 weeks or more
* English-speaking
* Women must receive OB care.
* Women may have past or present subclinical Major Depressive Disorder according to the DSM-IV.

Exclusion Criteria for all:

* Women must have no Active Alcohol Abuse or Dependence, Active Abuse or Dependence of Opiates, Inhalants, Amphetamines including Ecstasy or LSD, Active IV Drug Abuse, or Methadone Maintenance.
* Women must not take drugs in the FDA categories D or X.

Additional Exclusion Criteria for Control Subjects:

* Women must have no lifetime history of Bipolar Disorder or antimanic drug use.

Primary outcomes:
measure: SIGH-ADS
timeFrame: 20, 30 36 weeks gestation, 2,12,28,52 weeks postpartum
measure: Mania Rating Scale
timeFrame: 20, 30 36 weeks gestation, 2,12,28,52 weeks postpartum
measure: Bayley Scales of Infant Development
timeFrame: 12, 28, 52 weeks postpartum
Secondary outcomes:
measure: Weight gain in pregnancy
timeFrame: 20,30,36 weeks gestation
measure: Structured Clinical Interview for DSM-IV
timeFrame: 20 weeks gestation at enrollment
measure: Nutritional Blood Levels
timeFrame: 20, 30 36 weeks gestation, 2,12,28,52 weeks postpartum
measure: Maternal Functioning and Gratification
timeFrame: 2, 12, 28, 52 weeks postpartum
measure: Infant physical exam
timeFrame: 2,12,28,52 weeks post delivery
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: University of Pittsburgh
state: Pennsylvania
Study officials:
affiliation: Department of Psychiatry, School of Medicine, University of Pittsburgh
name: Katherine L Wisner, MD MS
role: PRINCIPAL_INVESTIGATOR
References:
citation: Wisner KL, Sit D, O'Shea K, Bogen DL, Clark CT, Pinheiro E, Yang A, Ciolino JD. Bipolar disorder and psychotropic medication: Impact on pregnancy and neonatal outcomes. J Affect Disord. 2019 Jan 15;243:220-225. doi: 10.1016/j.jad.2018.09.045. Epub 2018 Sep 18.
citation: Yang A, Ciolino JD, Pinheiro E, Rasmussen-Torvik LJ, Sit DKY, Wisner KL. Neonatal Discontinuation Syndrome in Serotonergic Antidepressant-Exposed Neonates. J Clin Psychiatry. 2017 May;78(5):605-611. doi: 10.4088/JCP.16m11044.
citation: Santucci AK, Singer LT, Wisniewski SR, Luther JF, Eng HF, Sit DK, Wisner KL. One-Year Developmental Outcomes for Infants of Mothers With Bipolar Disorder. J Clin Psychiatry. 2017 Sep-Oct;78(8):1083-1090. doi: 10.4088/JCP.15m10535.
citation: Kim DR, Pinheiro E, Luther JF, Eng HF, Dills JL, Wisniewski SR, Wisner KL. Is third trimester serotonin reuptake inhibitor use associated with postpartum hemorrhage? J Psychiatr Res. 2016 Feb;73:79-85. doi: 10.1016/j.jpsychires.2015.11.005. Epub 2015 Nov 19.