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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00238576
Recruitment Status : Completed
First Posted : October 13, 2005
Last Update Posted : April 21, 2016
Information provided by (Responsible Party):
Natalie Rasgon, Stanford University

Brief 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.

Condition or disease
Bipolar Disorder

Study Type : Observational
Actual Enrollment : 30 participants
Time Perspective: Cross-Sectional
Official Title: Lamotrigine in the Treatment of Bipolar Disorder in Women of Reproductive Age
Study Start Date : May 2008
Actual Primary Completion Date : December 2011
Actual Study Completion Date : May 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bipolar Disorder
Drug Information available for: Lamotrigine

Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. Menstrual cycle length and presence or absence of ovulation [ Time Frame: 6 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Females age 18 through 45 with a diagnosis of bipolar, considering treatment with Lamotragine.

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00238576

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
Principal Investigator: Dr Natalie Rasgon Stanford University

Additional Information:
Responsible Party: Natalie Rasgon, Principal Investigator, Stanford University Identifier: NCT00238576     History of Changes
Other Study ID Numbers: 79890
SPO# 30264
First Posted: October 13, 2005    Key Record Dates
Last Update Posted: April 21, 2016
Last Verified: December 2012

Additional relevant MeSH terms:
Bipolar Disorder
Pathologic Processes
Bipolar and Related Disorders
Mental Disorders
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers