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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Natalie Rasgon, Stanford University
ClinicalTrials.gov Identifier:
NCT00238576
First received: October 11, 2005
Last updated: May 14, 2014
Last verified: December 2012
  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: Time Perspective: Cross-Sectional
Official Title: Lamotrigine in the Treatment of Bipolar Disorder in Women of Reproductive Age

Resource links provided by NLM:


Further study details as provided by Stanford University:

Primary Outcome Measures:
  • Changes in weight, glucose, lipid levels , insulin and testosterone concentrations over 6 months onmedication [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    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:
  • Menstrual cycle length and presence or absence of ovulation [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Enrollment: 30
Study Start Date: May 2008
Estimated Primary Completion Date: December 2016 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders 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.

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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:
No publications provided

Responsible Party: Natalie Rasgon, Principal Investigator, Stanford University
ClinicalTrials.gov Identifier: NCT00238576     History of Changes
Other Study ID Numbers: 79890, SPO# 30264
Study First Received: October 11, 2005
Last Updated: May 14, 2014
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Bipolar Disorder
Disease
Affective Disorders, Psychotic
Mental Disorders
Mood Disorders
Pathologic Processes
Lamotrigine
Anticonvulsants
Calcium Channel Blockers
Cardiovascular Agents
Central Nervous System Agents
Excitatory Amino Acid Agents
Excitatory Amino Acid Antagonists
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Pharmacologic Actions
Physiological Effects of Drugs
Sodium Channel Blockers
Therapeutic Uses
Voltage-Gated Sodium Channel Blockers

ClinicalTrials.gov processed this record on October 21, 2014