NCT03774641Completed
A Pilot Study of Prophylactic Management of Lamotrigine in Pregnant Women
A Pilot Study of Prophylactic Management of Lamotrigine for Bipolar Disorder in Pregnant Women
Source: ClinicalTrials.gov · Last updated 5 Mar 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 10 (actual)
- First submitted
- 11 Dec 2018
- Start date
- 3 Dec 2018
- Primary completion date
- 16 Apr 2024
- Lead sponsor
- Johns Hopkins University
- Diseases
- Depression, Bipolar disorder
- NCT number
- NCT03774641
What you commit to
- Study type: Observational
- Participants enrolled: 10
- From 3 Dec 2018 to the primary completion date, 16 Apr 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- alcohol, marijuana, or other drug dependence in last 90 days
Other
- suicidal/clinically unstable
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: Female · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| 550 N Broadway Coordinator of this site? Confirm its status | Baltimore | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.