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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

30 participants

Study Classification

OBSERVATIONAL

Study Start Date

2008-05-31

Study Completion Date

2012-05-31

Brief Summary

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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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Detailed Description

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Conditions

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Bipolar Disorder

Study Design

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Study Time Perspective

CROSS_SECTIONAL

Eligibility Criteria

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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

Exclusion Criteria

* 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

Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No