Lamotrigine in the Treatment of Bipolar Disorder in Women of Reproductive Age
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Changes in weight, glucose, lipid levels , insulin and testosterone concentrations over 6 months onmedication
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Changes in weight, glucose, lipid levels , insulin and testosterone concentrations over 6 months onmedication
时间窗: 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.
次要结局
- Menstrual cycle length and presence or absence of ovulation(6 months)
研究者
Natalie Rasgon
Principal Investigator
Stanford University