Lamotrigine in the Treatment of Bipolar Disorder in Women of Reproductive Age

Stanford University

Status: Completed

Conditions: Bipolar Disorder

Study type: Observational

Funder types: Other

Identifiers

NCT00238576

SPO# 30264

79890

Details and patient eligibility

About

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.

Enrollment: 30 patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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