Status:
COMPLETED
Menstrual Effects On Mood Symptoms in Bipolar Disorder
Lead Sponsor:
University of Pittsburgh
Conditions:
Bipolar Disorder
Eligibility:
FEMALE
18-45 years
Brief Summary
Background and Rationale for Study: Estrogen and progesterone are female hormones that regulate the menstrual cycle and likely serve an important role in the regulation of mood. Premenstrual Syndrome ...
Detailed Description
Study Design: Women with BD (15 depressed, 15 euthymic), and 15 healthy women will enter the study. Over 3-months, subjects undergo monthly visits to assess mood and function, at the follicular and lu...
Eligibility Criteria
Inclusion
- Ages 18-45;
- Bipolar Disorder (BD) I or II (DSM-IV criteria) must agrees to communication between PI and Psychiatrist;
- Healthy Control without Past or Current Major Depression, Psychotic Disorder, premenstrual syndrome or Premenstrual Dysphoric Disorder;
- 25-31day menstrual cycles;
- Minimum 6 menstrual cycles per year
Exclusion
- Current DSM-IV Criteria Alcohol or Substance Abuse/Dependence;
- Pregnancy;
- Chronic Anovulation (\<4 menstrual cycles/yr);
- Menopause (\< 1menses in 1yr);
- Active thyroid disease;
- Hormonal Contraception
Key Trial Info
Start Date :
August 1 2006
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
June 1 2008
Estimated Enrollment :
45 Patients enrolled
Trial Details
Trial ID
NCT00472615
Start Date
August 1 2006
End Date
June 1 2008
Last Update
February 26 2009
Active Locations (2)
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1
Magee Womens Hospital, UPMC
Pittsburgh, Pennsylvania, United States, 15213
2
University of Pittsburgh, School of Medicine, Department of Psychiatry
Pittsburgh, Pennsylvania, United States, 15213