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

Completed

• Conditions: Bipolar Disorder

• Registration Number: NCT00238576
• Lead Sponsor: Stanford University

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2005-10-11
• Study First Submitted QC: 2005-10-11
• Study First Posted: 2005-10-13
• Study Start: 2008-05
• Primary Completion: 2011-12
• Study Completion: 2012-05
• Status Verified: 2012-12
• Last Update Submitted: 2016-04-19
• Last Update Posted: 2016-04-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 30

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Changes in weight, glucose, lipid levels , insulin and testosterone concentrations over 6 months onmedication	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

Name	Time	Method
Menstrual cycle length and presence or absence of ovulation	6 months

Trial Locations

Locations (2)

Department of Psychiatry and Behavioral Sciences, Stanford University School of Medicine; 🇺🇸 Stanford, California, United States

Stanford University School of Medicine; 🇺🇸 Stanford, California, United States