Status:
COMPLETED
Reproductive Function and Mood in Women With Bipolar Disorder
Lead Sponsor:
Stanford University
Collaborating Sponsors:
National Institute of Mental Health (NIMH)
Conditions:
Bipolar Disorder
Mental Health
Eligibility:
FEMALE
18-40 years
Brief Summary
This study will determine the effect of medication for bipolar disorder on the reproductive function and whether mood changes occur during the menstrual cycle in women with bipolar disorder.
Detailed Description
Bipolar disorder is a serious condition that can have devastating effects on social and psychological functioning. Evidence suggests that medications for bipolar disorder may influence reproduction fu...
Eligibility Criteria
Inclusion
- Inclusion Criteria for All Participants:
- Have been menstruating for at least 4 years prior to study entry
- Participants must be willing to travel to Stanford University at own expense for study visits
- Inclusion Criteria for Bipolar Disorder Participants:
- Participants should have a diagnosis of Bipolar I, Bipolar II, or Bipolar not otherwise specified (NOS), and be under the treatment of a physician who can be contacted in case of an emergency
- Current treatment with any mood-stabilizing agent for a period of at least 3 months (e.g., divalproex sodium, lithium, other mood stabilizer, or atypical antipsychotic)
- Inclusion Criteria for Healthy Controls:
- No past or present diagnosis of mental illness
- Exclusion Criteria for All Participants:
- Current alcohol or substance abuse or dependence within 6 months prior to study entry
- Meets criteria for another DSM-IV Axis I disorder
- Contraceptive steroid use within 3 months prior to study entry
- Current use of medication that may affect steroid metabolism
- Menopausal
- Endocrine disease such as diabetes or hypothyroidism
- Uncontrolled medical illness
- History of long-term corticosteroid use
- Organic mood disorder
- Pregnancy or breastfeeding within 3 months prior to study entry
Exclusion
Key Trial Info
Start Date :
January 1 2004
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
July 1 2008
Estimated Enrollment :
90 Patients enrolled
Trial Details
Trial ID
NCT00183352
Start Date
January 1 2004
End Date
July 1 2008
Last Update
May 16 2014
Active Locations (1)
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1
Stanford University School of Medicine
Stanford, California, United States, 94305