Lamotrigine in the Treatment of Bipolar Disorder in Women of Reproductive Age
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government.
Read our disclaimer for details.
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.
Changes in weight, glucose, lipid levels , insulin and testosterone concentrations over 6 months onmedication [ Time Frame: 6 months ]
This is a research study to determine how effective lamotrigine is in the treatment of bipolar disorder in women of reproductive age. Participants are between the ages of 18 and 45, have been diagnosed with bipolar disorder, and have indicated that they are about to begin or are considering treatment with lamotrigine. The purposes of this study are to explore the safety of lamotrigine in treating bipolar I disorder, bipolar II disorder, and rapid cycling bipolar disorder in women compared to other mood stabilizers and anti-depressants. In addition, this study aims to explore lamotrigine's effects on the association between the mood and the menstrual cycle and to compare the effects of various medications that participants receive for treatment of their illness in regards to reproductive hormone levels.
Secondary Outcome Measures
Menstrual cycle length and presence or absence of ovulation [ Time Frame: 6 months ]
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study:
18 Years to 45 Years (Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Females age 18 through 45 with a diagnosis of bipolar, considering treatment with Lamotragine.
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