Clinical trial NCT03774641: A Pilot Study of Prophylactic Management of Lamotrigine in Pregnant Women
Official title: A Pilot Study of Prophylactic Management of Lamotrigine for Bipolar Disorder in Pregnant Women
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Bipolar Disorder
Major Depressive Disorder
Schizo Affective Disorder
Keywords: Lamotrigine
Bipolar Disorder
Major Depressive Disorder
Schizo Affective Disorder
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
Collaborators: name: National Institute on Aging (NIA)
First posted: 2018-12-13
Enrollment: 10
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Pregnant women who are currently taking Lamotrigine for Bipolar Disorder, Major Depressive Disorder, Schizoaffective Disorder, or another psychiatric illness, and plan to continue throughout pregnancy.

Brief summary: Pregnant women who are taking lamotrigine will be evaluated monthly during pregnancy including a clinical evaluation and a blood draw for lamotrigine levels at each visit. Based on the Therapeutic Drug Monitoring protocol, participant's lamotrigine dosing will be adjusted as needed based on participant's blood levels compared to the reference concentration that was obtained prior to pregnancy or early in pregnancy while clinically stable. After delivery participant and participant's infants will be assessed for mood and functioning at 1, 2, 4, and 6 weeks postpartum.

Detailed description: Studies have demonstrated that at least 80% of women who stop mood stabilizing medications for pregnancy relapse psychiatrically. However, relapse is also quite common in women who continue taking mood stabilizing medication with studies demonstrating approximately a 30-37% relapse rate-most with depressive episodes. One likely explanation for the high relapse rate of Bipolar Disorder during pregnancy despite continued mood stabilizing medication is decreasing blood levels of mood stabilizing medications during the course of pregnancy. Pregnancy induces both pharmacokinetic and pharmacodynamic changes, which can result in decreased serum blood levels and decreased treatment efficacy. Therapeutic drug monitoring is considered standard of care for a number of psychiatric medications. Therapeutic drug monitoring can be an especially crucial guide to clinical treatment during pregnancy, but remarkably, there are no established protocols for the monitoring of levels and dosing of psychiatric medications in pregnancy. Most pregnant psychiatric patients are therefore managed based on symptom recurrence. In contrast, there are established protocols for monitoring blood levels and prophylactic management of antiepileptic medications for epilepsy, including lamotrigine which is also a mood stabilizing medication. The investigators will collect pilot data on the psychiatric outcomes, adverse events, and obstetrical and infant outcomes of pregnant women with Bipolar Disorder who undergo prophylactic therapeutic drug monitoring for a commonly used mood stabilizing medication during pregnancy- lamotrigine. In the epilepsy literature, there is a published protocol for lamotrigine management before, during, and after pregnancy for seizure control; the investigators will use this protocol as a guide.

Eligibility criteria: Inclusion Criteria:

* pregnant, prior or 20 weeks
* currently taking Lamotrigine and plan to continue throughout pregnancy
* history of Bipolar Disorder, Major Depressive Disorder, Schizoaffective Disorder or other psychiatric illness, currently stable
* may be taking other psychiatric medications

Exclusion Criteria:

* suicidal/clinically unstable
* alcohol, marijuana, or other drug dependence in last 90 days

Primary outcomes:
measure: Change in Mood as assessed by The Edinburgh Postnatal Rating Scale
timeFrame: Monthly, after enrollment, up to 10 months
measure: Change in Mood as assessed by The Young Mania Rating Scale
timeFrame: Monthly, after enrollment, up to 10 months
measure: Side Effect as assessed by the Udvalg for Kliniske Undersøgelser Side Effects Rating Scale
timeFrame: Monthly, after enrollment, up to 10 months
measure: Side Effect as assessed by the Frequency, Intensity, and Burden of Side Effects Rating Scale
timeFrame: Monthly, after enrollment, up to 10 months
measure: Change in Infant Habituation as assessed by the Neonatal Intensive Care Unit Network Neurobehavioral Scale
timeFrame: At 1, 2, 4, and 6 weeks postpartum
measure: Change in Infant Attention as assessed by the Neonatal Intensive Care Unit Network Neurobehavioral Scale
timeFrame: At 1, 2, 4, and 6 weeks postpartum
measure: Change in Infant Self-Regulation as assessed by the Neonatal Intensive Care Unit Network Neurobehavioral Scale
timeFrame: At 1, 2, 4, and 6 weeks postpartum
measure: Change in Infant Arousal as assessed by the Neonatal Intensive Care Unit Network Neurobehavioral Scale
timeFrame: At 1, 2, 4, and 6 weeks postpartum
measure: Change in Infant Tonicity as assessed by the Neonatal Intensive Care Unit Network Neurobehavioral Scale
timeFrame: At 1, 2, 4, and 6 weeks postpartum
measure: Change in Infant Reflexes as assessed by the Neonatal Intensive Care Unit Network Neurobehavioral Scale
timeFrame: At 1, 2, 4, and 6 weeks postpartum
measure: Change in Infant Quality of Movement as assessed by the Neonatal Intensive Care Unit Network Neurobehavioral Scale
timeFrame: At 1, 2, 4, and 6 weeks postpartum
measure: Gestational Age at Birth in Weeks assessed by Review of the Infant Delivery Chart
timeFrame: At 2 weeks postpartum visit, up to 15 minutes
measure: Birth Length in Inches assessed by Review of the Infant Delivery Chart
timeFrame: At 2 weeks postpartum visit, up to 15 minutes
measure: Birth Weight in pounds assessed by Review of the Infant Delivery Chart
timeFrame: At 2 weeks postpartum visit, up to 15 minutes
measure: APGAR Score at 1 Minute assessed by Review of the Infant Delivery Chart
timeFrame: At 2 weeks postpartum visit, up to 15 minutes
measure: APGAR Score at 5 Minutes assessed by Review of the Infant Delivery Chart
timeFrame: At 2 weeks postpartum visit, up to 15 minutes
measure: Assessment of Neonatal Intensive Care Unit Admission by Review of the Infant Delivery Chart
timeFrame: At 2 weeks postpartum visit, up to 15 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: 550 N Broadway
state: Maryland
Study officials:
affiliation: Johns Hopkins University
name: Lindsay Standeven, MD
role: PRINCIPAL_INVESTIGATOR
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