Lamotrigine in the Treatment of Bipolar Disorder in Women of Reproductive Age
Information source: Stanford University
Information obtained from ClinicalTrials.gov on March 21, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Bipolar Disorder
Phase: N/A
Status: Recruiting
Sponsored by: Stanford University Official(s) and/or principal investigator(s):
Natalie L Rasgon, M.D., Ph.D., Principal Investigator, Affiliation: Stanford University
Overall contact:
Margaret F Reynolds, B.A., Phone: (650) 725-2528, Email: mforbes@stanford.edu
Summary
This project will expand current knowledge of reproductive biology in women with bipolar
disorder as well as assessing the impact of lamotrigine use for the treatment of bipolar
disorder on reproductive function. Specifically, this study examines mood over the menstrual
cycle and ovulation for three consecutive menstrual cycles in women treated for bipolar I,
II, or NOS (not otherwise specified) with lamotrigine. In addition, testosterone and lipid
concentrations will be measured before the participant starts receiving lamotrigine, as well
as six months after receiving lamotrigine.
Clinical Details
Official title: Lamotrigine in the Treatment of Bipolar Disorder in Women of Reproductive Age
Study design: Natural History, Longitudinal, Defined Population, Prospective Study
Eligibility
Minimum age: 18 Years.
Maximum age: 45 Years.
Gender(s): Female.
Criteria:
Inclusion Criteria:
- Female
- Ages 18 through 45
- Diagnosis of bipolar disorder (I, II, or NOS)
- Willing to sign the Human Subject Protection Consent Form prior to enrollment into the
study
- Willing to use lamotrigine
- Never used lamotrigine prior to study entry
Exclusion Criteria:
- Unwilling or unable to comply with study requirements, e. g. complete forms, or attend
scheduled evaluations
- Significant alcohol and/or substance abuse or dependence within the prior 6 months
- Used lamotrigine prior to study entry, or currently using lamotrigine at study entry
Locations and Contacts
Margaret F Reynolds, B.A., Phone: (650) 725-2528, Email: mforbes@stanford.edu
Department of Psychiatry and Behavioral Sciences, Stanford University School of Medicine, Stanford, California 94305, United States; Recruiting
Pascale G Stemmle, B.S., Phone: 650-725-2528, Email: pascale@stanford.edu
Heather Kenna, M.A., Phone: (650) 724-0521, Email: hkenna@stanford.edu
Additional Information
Behavioral Neuroendocrinology Program website
Last updated: February 8, 2007
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