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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.
Conditions:
🦠 Bipolar Disorder 🦠 Major Depressive Disorder 🦠 Schizo Affective Disorder
🗓️ Study Start (Actual) 3 December 2018
🗓️ Primary Completion (Estimated) 30 March 2025
✅ Study Completion (Estimated) 30 March 2025
👥 Enrollment (Estimated) 20
🔬 Study Type OBSERVATIONAL
📊 Phase N/A
Locations:
📍 Baltimore, Maryland, United States

📋 Eligibility Criteria

Description

    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
Ages Eligible for Study: 18 Years to N/A (ADULT, OLDER_ADULT)
Sexes Eligible for Study: FEMALE
Accepts Healthy Volunteers: No

🗓️ Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

  • First Submitted 11 December 2018
  • First Submitted that Met QC Criteria 11 December 2018
  • First Posted 13 December 2018

Study Record Updates

  • Last Update Submitted that Met QC Criteria 22 April 2024
  • Last Update Posted 24 April 2024
  • Last Verified April 2024
I'm interested ...!!