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Lamotrigine in the Treatment of Bipolar Disorder in Women of Reproductive Age | Clinical Trials | Clareo Health

COMPLETED

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

NCT00238576•Stanford University

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.

Eligibility

Age

18 - 45 years

Sex

FEMALE

Healthy Volunteers

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

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

Key Dates

Start Date

May 1, 2008

Primary Completion Date

December 1, 2011

Completion Date

May 1, 2012

Last Updated

April 21, 2016

Enrollment

ACTUAL participants

Conditions

Bipolar Disorder

University of Iowa Interventional Psychiatry Service Patient Registry

NCT04480918

Treatment Resistant DepressionMajor Depressive Episode+5 more

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RECRUITINGPHASE3

A Study to Evaluate the Efficacy and Safety of Adjunctive KarXT for the Treatment of Mania, With or Without Mixed Features, in Participants With Bipolar-I Disorder Taking Lithium, Valproate, or Lamotrigine

NCT07140913

ManiaBipolar Disorder

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: April 21, 2016Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

University of Iowa Interventional Psychiatry Service Patient Registry

A Study to Evaluate the Efficacy and Safety of Adjunctive KarXT for the Treatment of Mania, With or Without Mixed Features, in Participants With Bipolar-I Disorder Taking Lithium, Valproate, or Lamotrigine

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A Randomized Study of Azetukalner Versus Placebo in Depressive Episodes Associated With Bipolar I or II Disorder (Bipolar Depression)

Early Intervention for Youth at High Risk for Bipolar Disorder