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Completed

NCT Number: NCT03774641

A Pilot Study of Prophylactic Management of Lamotrigine in Pregnant Women

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.

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Key information

Conditions

Bipolar Disorder Bipolar and Related Disorders Depressive Disorder Depressive Disorder, Major Major Depressive Disorder Mental Disorders Mood Disorders Psychotic Disorders Schizo Affective Disorder Schizophrenia Spectrum and Other Psychotic Disorders

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

550 N Broadway

Baltimore, Maryland, 21205, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

lamictal

Drug

Blood-serum levels will be checked monthly during pregnancy and reference concentration will be maintained

Other names: Lamotrigine

Primary outcomes

  1. Change in Mood as assessed by The Edinburgh Postnatal Rating Scale

    Time frame: Monthly, after enrollment, up to 10 months

    Self-reported experience of depressive symptoms over the past 7 days, each item is scored 0-3 (0=not experiencing the symptom, 3=experiencing the symptom most of the time) yielding a total between 0 and 30. A score of 0-9 indicates little to no depressive symptoms and a score from 10-30 indicates significant depressive symptoms.

  2. Change in Mood as assessed by The Young Mania Rating Scale

    Time frame: Monthly, after enrollment, up to 10 months

    Clinical interview that measures manic symptoms in the past 2 weeks, each item is scored 0-4 (0=absent, 4=fully present) yielding a total between 0 and 44. Any score above 0 indicates a possible manic episode.

  3. Side Effect as assessed by the Udvalg for Kliniske Undersøgelser Side Effects Rating Scale

    Time frame: Monthly, after enrollment, up to 10 months

    Clinical interview that measures current, or in the past 72 hours, side effects of medication, each item is scored 0-3 (0=not or doubtfully present, 3=severe), yielding a total between 0 and 168. Any score above 0 indicates a possible causal relationship between medication and side effects.

  4. Side Effect as assessed by the Frequency, Intensity, and Burden of Side Effects Rating Scale

    Time frame: Monthly, after enrollment, up to 10 months

    Self-reported frequency, intensity, and burden of side effects in the past week, each item is scored 0-6 (0=no side effects/impairment, 6=present all the time/intolerable/unable to function) yielding a total between 0 and 18. For each item, a score of 0-2 indicates treatment should continue, a score of 3-4 indicates the side effect should be addressed, and a score of 5-6 indicates a change in treatment is needed.

  5. Change in Infant Habituation as assessed by the Neonatal Intensive Care Unit Network Neurobehavioral Scale

    Time frame: At 1, 2, 4, and 6 weeks postpartum

    Neurobehavioral assessment measuring infant's ability to shut down response to a stimulus, the item is scored 1-9, a low score indicates no decrement in response over 10 stimuli and a high score indicates a shut down of response after 1-2 stimuli

  6. Change in Infant Attention as assessed by the Neonatal Intensive Care Unit Network Neurobehavioral Scale

    Time frame: At 1, 2, 4, and 6 weeks postpartum

    Neurobehavioral assessment measuring infant's response to a stimulus, the item is scored 1-9, a low score indicates no response and a high score indicates alerting to stimulus

  7. Change in Infant Self-Regulation as assessed by the Neonatal Intensive Care Unit Network Neurobehavioral Scale

    Time frame: At 1, 2, 4, and 6 weeks postpartum

    Neurobehavioral assessment measuring infant's ability to self-regulate, the item is scored 1-9, a low score indicates the infant makes no attempt to quiet self and a high score indicates the infant consistently quiets self for sustained periods

  8. Change in Infant Arousal as assessed by the Neonatal Intensive Care Unit Network Neurobehavioral Scale

    Time frame: At 1, 2, 4, and 6 weeks postpartum

    Neurobehavioral assessment measuring infant's arousal, the item is scored 1-9, a low score indicates a low level of arousal to all stimuli and a high score indicates the infant achieves insulated crying

  9. Change in Infant Tonicity as assessed by the Neonatal Intensive Care Unit Network Neurobehavioral Scale

    Time frame: At 1, 2, 4, and 6 weeks postpartum

    Neurobehavioral assessment measuring infant's body tone, the item is scored 1-9, a low score indicates the infant is flaccid and a high score indicates the infant is hypertonic

  10. Change in Infant Reflexes as assessed by the Neonatal Intensive Care Unit Network Neurobehavioral Scale

    Time frame: At 1, 2, 4, and 6 weeks postpartum

    Neurobehavioral assessment measuring infant's reflexes, the item is scored 1-5, a low score indicates no response and a high score indicates a strong response

  11. Change in Infant Quality of Movement as assessed by the Neonatal Intensive Care Unit Network Neurobehavioral Scale

    Time frame: At 1, 2, 4, and 6 weeks postpartum

    Neurobehavioral assessment measuring infant's power and flexibility, the item is scored 1-5, a low score indicates no resistance/movement and a high score indicates strong resistance/movement

  12. Gestational Age at Birth in Weeks assessed by Review of the Infant Delivery Chart

    Time frame: At 2 weeks postpartum visit, up to 15 minutes

  13. Birth Length in Inches assessed by Review of the Infant Delivery Chart

    Time frame: At 2 weeks postpartum visit, up to 15 minutes

  14. Birth Weight in pounds assessed by Review of the Infant Delivery Chart

    Time frame: At 2 weeks postpartum visit, up to 15 minutes

  15. APGAR Score at 1 Minute assessed by Review of the Infant Delivery Chart

    Time frame: At 2 weeks postpartum visit, up to 15 minutes

  16. APGAR Score at 5 Minutes assessed by Review of the Infant Delivery Chart

    Time frame: At 2 weeks postpartum visit, up to 15 minutes

  17. Assessment of Neonatal Intensive Care Unit Admission by Review of the Infant Delivery Chart

    Time frame: At 2 weeks postpartum visit, up to 15 minutes

    By reviewing the infant delivery chart, the outcome will be "yes" if the infant was admitted to the Neonatal Intensive Care Unit and "no" if the infant was not admitted

Sponsors and collaborators

Lead sponsor

Johns Hopkins University

Other

Collaborators

  • National Institute on Aging (NIA)

Registry information

Official study title

A Pilot Study of Prophylactic Management of Lamotrigine for Bipolar Disorder in Pregnant Women

Important dates

Study start
2018
Primary completion
2024
Study completion
2024
First posted
Dec 13, 2018
Registry last updated
Mar 5, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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