Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT03774641 · ClinicalTrials.gov registry record
A Pilot Study of Prophylactic Management of Lamotrigine in Pregnant Women
A clinical trial, sponsored by Johns Hopkins University.
- Completed
- Registry status
- 10
- Enrollment target
NCT03774641: Completed study, sponsored by Johns Hopkins University.
NCT03774641 is a clinical trial that has completed, run by Johns Hopkins University. The registered enrollment target is 10 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03774641 has completed, sponsored by Johns Hopkins University.
- COMPLETED
- Registry status
- 10 participants
- Enrollment target
Study 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.
Primary Outcome
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.
Interventions
- DRUG Lamictal
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 10 participants |
| Start Date | 2018-12-03 |
| Est. Completion | 2024-04-16 |
What the finished NCT03774641 record still lists
NCT03774641 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 10 participants, a relatively small participant target.
The record links to 0 conditions, and to 1 intervention - of which Lamictal is the first listed.
NCT03774641 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03774641 about?
NCT03774641 is a clinical study titled "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 particip...
What is the current status of trial NCT03774641?
This trial is currently completed. The enrollment target is 10 participants. The study started on 2018-12-03. Estimated completion is 2024-04-16.
What interventions are being tested in trial NCT03774641?
The interventions under investigation include: Lamictal (DRUG).
Who is sponsoring clinical trial NCT03774641?
This trial is sponsored by Johns Hopkins University, which has 1,448 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT00623389 · 10 participants · NA
Evaluation of an Advanced Lower Extremity Neuroprostheses
- NCT01241864 · 10 participants · Phase 2
Islet Transplantation in Type 1 Diabetic Kidney Allograft
- NCT01293214 · 10 participants · NA
Vascularized Composite Allotransplantation for Multiple Extremity Amputations
- NCT01474148 · 10 participants · NA
A Neuroprosthesis for Seated Posture and Balance
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI