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

Bipolar Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00238576
• Other study ID #: 79890
• Secondary ID: SPO# 30264
• Status: Completed
• Phase: N/A
• First received: October 11, 2005
• Last updated: April 19, 2016
• Start date: May 2008
• Est. completion date: May 2012

Study information

• Verified date: December 2012
• Source: Stanford University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: May 2012
• Est. primary completion date: December 2011
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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

Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Bipolar Disorder

Locations

Country	Name	City	State
United States	Department of Psychiatry and Behavioral Sciences, Stanford University School of Medicine	Stanford	California
United States	Stanford University School of Medicine	Stanford	California

Sponsors (1)

Lead Sponsor	Collaborator
Stanford University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in weight, glucose, lipid levels , insulin and testosterone concentrations over 6 months onmedication	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.	6 months	No
Secondary	Menstrual cycle length and presence or absence of ovulation		6 months	No

External Links

•   Behavioral Neuroendocrinology Program website