A Pilot Study of Prophylactic Management of Lamotrigine in Pregnant Women
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| ClinicalTrials.gov Identifier: NCT03774641 |
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Recruitment Status :
Recruiting
First Posted : December 13, 2018
Last Update Posted : December 14, 2020
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Sponsor:
Johns Hopkins University
Information provided by (Responsible Party):
Johns Hopkins University
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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.
| Condition or disease | Intervention/treatment |
|---|---|
| Bipolar Disorder Major Depressive Disorder Schizo Affective Disorder | Drug: Lamictal |
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.
| Study Type : | Observational |
| Estimated Enrollment : | 20 participants |
| Observational Model: | Case-Only |
| Time Perspective: | Prospective |
| Official Title: | A Pilot Study of Prophylactic Management of Lamotrigine for Bipolar Disorder in Pregnant Women |
| Actual Study Start Date : | December 3, 2018 |
| Estimated Primary Completion Date : | December 31, 2021 |
| Estimated Study Completion Date : | December 31, 2021 |
Resource links provided by the National Library of Medicine
MedlinePlus related topics:
Bipolar Disorder
Drug Information available for:
Lamotrigine
| Group/Cohort | Intervention/treatment |
|---|---|
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Taking Lamotrigine
Lamotrigine (Lamictal), dosage will be based on a reference concentration of blood-serum levels
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Drug: Lamictal
Blood-serum levels will be checked monthly during pregnancy and reference concentration will be maintained
Other Name: Lamotrigine |
Primary Outcome Measures :
- 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.
- 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.
- 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.
- 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.
- 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
- 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
- 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
- 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
- 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
- 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
- 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
- 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 ]
- Birth Length in Inches assessed by Review of the Infant Delivery Chart [ Time Frame: At 2 weeks postpartum visit, up to 15 minutes ]
- Birth Weight in pounds assessed by Review of the Infant Delivery Chart [ Time Frame: At 2 weeks postpartum visit, up to 15 minutes ]
- APGAR Score at 1 Minute assessed by Review of the Infant Delivery Chart [ Time Frame: At 2 weeks postpartum visit, up to 15 minutes ]
- APGAR Score at 5 Minutes assessed by Review of the Infant Delivery Chart [ Time Frame: At 2 weeks postpartum visit, up to 15 minutes ]
- 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
Biospecimen Retention: Samples Without DNA
Serum
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
| 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.
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
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03774641
Contacts
| Contact: Courtney N Erdly | 410-502-3750 | cerdly1@jhmi.edu | |
| Contact: Samantha Meilman | 410-502-2586 | smeilma1@jhmi.edu |
Locations
| United States, Maryland | |
| 550 N Broadway | Recruiting |
| Baltimore, Maryland, United States, 21205 | |
| Contact: Courtney N Erdly | |
| Principal Investigator: Jennifer L Payne, MD | |
Sponsors and Collaborators
Johns Hopkins University
Investigators
| Principal Investigator: | Jennifer L Payne, MD | Johns Hopkins University |
Study Documents (Full-Text)
Publications:
| Responsible Party: | Johns Hopkins University |
| ClinicalTrials.gov Identifier: | NCT03774641 |
| Other Study ID Numbers: |
IRB00162134 |
| First Posted: | December 13, 2018 Key Record Dates |
| Last Update Posted: | December 14, 2020 |
| Last Verified: | December 2020 |
| Studies a U.S. FDA-regulated Drug Product: | Yes |
| Studies a U.S. FDA-regulated Device Product: | No |
| Product Manufactured in and Exported from the U.S.: | No |
Keywords provided by Johns Hopkins University:
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Lamotrigine Bipolar Disorder Major Depressive Disorder Schizo Affective Disorder |
Additional relevant MeSH terms:
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Disease Depressive Disorder Depression Depressive Disorder, Major Bipolar Disorder Mood Disorders Psychotic Disorders Pathologic Processes Mental Disorders Behavioral Symptoms Bipolar and Related Disorders Schizophrenia Spectrum and Other Psychotic Disorders |
Lamotrigine Anticonvulsants Calcium Channel Blockers Membrane Transport Modulators Molecular Mechanisms of Pharmacological Action Calcium-Regulating Hormones and Agents Physiological Effects of Drugs Antipsychotic Agents Tranquilizing Agents Central Nervous System Depressants Psychotropic Drugs Sodium Channel Blockers |