Menstrual Effects On Mood Symptoms in Bipolar Disorder
Completed
Conditions studied: Bipolar Disorder
In brief
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 (PMS) which affects 75% of healthy women is a cyclic pattern of mild dysphoria and physical discomfort that begin 1-2weeks pre-menses, and resolve by 2-3 days post-onset of menses. Up to 66% of women with bipolar disorder (BD) describe premenstrual mood changes that range from mild symptoms to severe worsening that require hospitalization. Therefore, the hormonal shifts of the menstrual cycle likely influence bipolar symptoms, but confirmatory research is lacking. Study questions: The primary aims and hypotheses are to characterize bipolar mood symptoms throughout the menstrual cycle and to determine if women with BD have: 1) a) increased severity and persistence of depression and mania symptoms in the late luteal (premenstrual) vs early follicular phase, b) larger change in mood symptoms from the late luteal (premenstrual) to the early follicular phase, compared to healthy women, 2) more relapses, in the late luteal compared to the early follicular phase. The secondary aims are to determine: 1) frequency and severity of premenstrual dysphoric disorder (PMDD) type symptoms in bipolar women; 2) association between bipolar mood variability and a) menstrual phase, b) ovulatory vs anovulatory cycles, c) antimanic drug treatment.
Key facts
- Study ID
- NCT00472615
- Run by
- University of Pittsburgh
- People needed
- 45
- Starts
- 2006-08-01
- Expected to finish
- 2008-06-01
- Last updated by the study team
- 2009-02-26
Who can join
Age: 18 and older, up to 45. Sex: female. Healthy volunteers: accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Magee Womens Hospital, UPMC — Pittsburgh, Pennsylvania, United States
- University of Pittsburgh, School of Medicine, Department of Psychiatry — Pittsburgh, Pennsylvania, United States
Full record on ClinicalTrials.gov
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