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

This study has been completed.

First Received: October 11, 2005 Last Updated: April 9, 2008 History of Changes

Sponsor:	Stanford University
Information provided by:	Stanford University
ClinicalTrials.gov Identifier:	NCT00238576

Purpose

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.

Condition
Bipolar Disorder

Study Type:	Observational
Study Design:	Prospective
Official Title:	Lamotrigine in the Treatment of Bipolar Disorder in Women of Reproductive Age

Resource links provided by NLM:

MedlinePlus related topics: Bipolar Disorder

Drug Information available for: Lamotrigine

U.S. FDA Resources

Further study details as provided by Stanford University:

Estimated Enrollment:

Eligibility

Ages Eligible for Study:	18 Years to 45 Years
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00238576

Locations

United States, California
Department of Psychiatry and Behavioral Sciences, Stanford University School of Medicine
Stanford, California, United States, 94305
Stanford University School of Medicine
Stanford, California, United States, 94305

Sponsors and Collaborators

Stanford University

Investigators

Principal Investigator:

Dr Natalie Rasgon

Stanford University

More Information

Additional Information:

Behavioral Neuroendocrinology Program website This link exits the ClinicalTrials.gov site

No publications provided

Study ID Numbers:	79890, SPO# 30264
Study First Received:	October 11, 2005
Last Updated:	April 9, 2008
ClinicalTrials.gov Identifier:	NCT00238576 History of Changes
Health Authority:	United States: Institutional Review Board

Additional relevant MeSH terms:

Disease
Molecular Mechanisms of Pharmacological Action
Bipolar Disorder
Calcium Channel Blockers
Cardiovascular Agents
Pharmacologic Actions
Membrane Transport Modulators
Affective Disorders, Psychotic

Pathologic Processes
Mental Disorders
Therapeutic Uses
Mood Disorders
Lamotrigine
Central Nervous System Agents
Anticonvulsants

ClinicalTrials.gov processed this record on November 27, 2009