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

Trial ID or NCT#

NCT00238576

Status

not recruiting iconNOT RECRUITING

Purpose

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.

Official Title

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

Eligibility Criteria

Ages Eligible for Study: 18 Years to 45 Years
Sexes Eligible for Study: Female
Accepts Healthy Volunteers: No
Inclusion Criteria:
  1. : - 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:
  1. - 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

Investigator(s)

Natalie L. Rasgon