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

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.

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Key information

Conditions

Bipolar Disorder Bipolar and Related Disorders Mental Disorders Mood Disorders

Age range

18 year–45 year

Sex eligibility

Female

Study type

Observational

Primary location

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

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 outcomes

Menstrual cycle length and presence or absence of ovulation

Time frame: 6 months

Sponsors and collaborators

Lead sponsor

Stanford University

Other

Registry information

Important dates

Study start: 2008
Primary completion: 2011
Study completion: 2012
First posted: Oct 13, 2005
Registry last updated: Apr 21, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed