Menstrual Effects On Mood Symptoms in Bipolar Disorder

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: NCT00472615
Recruitment Status : Completed
First Posted : May 14, 2007
Last Update Posted : February 26, 2009
Information provided by:
University of Pittsburgh

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 (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.

Condition or disease
Bipolar Disorder

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 luteal phases. Ovulation is confirmed with: 1) urine dipstick tests to detect ovulation (LH surge) days8-14 from the onset of menses; 2) serum progesterone levels 7-days post-ovulation (LH surge). Subjects record their mood and physical symptoms on the daily self-report LifeChart and the Daily Rating Form.

Study Population: Women with Bipolar I or II Disorder, between ages 18-45. Primary Outcomes Measures: 1) a) mood severity - scores on the Structured Interview Guide for the Hamilton Depression Scale (SIGHADS) for depression, Mania Rating Scale (MRS) for mania/hypomania, and LifeChart mood ratings depression and mania/hypomania, for the late luteal and early follicular phases; b) persistence of symptoms - proportion of days with mild/moderate/severe depression or mania/hypomania. 2) Relapses - # bipolar episodes.

Study Type : Observational
Estimated Enrollment : 45 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Menstrual Effects On Mood Symptoms in Bipolar Disorder
Study Start Date : August 2006
Actual Primary Completion Date : June 2008
Actual Study Completion Date : June 2008

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Biospecimen Retention:   Samples Without DNA
whole blood

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:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Community sample and outpatient psychiatric offices

Inclusion Criteria:

  • 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 Criteria:

  • 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

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): NCT00472615

United States, Pennsylvania
Magee Womens Hospital, UPMC
Pittsburgh, Pennsylvania, United States, 15213
University of Pittsburgh, School of Medicine, Department of Psychiatry
Pittsburgh, Pennsylvania, United States, 15213
Sponsors and Collaborators
University of Pittsburgh
Principal Investigator: Dorothy K Sit, M.D. University of Pittsburgh, School of Medicine, Department of Psychiatry

Additional Information:
Responsible Party: Dorothy Sit, M.D., Assistant Professor of Psychiatry, University of Pittsburgh, School of Medicine, Department of Psychiatry Identifier: NCT00472615     History of Changes
Other Study ID Numbers: M01RR000056 ( U.S. NIH Grant/Contract )
CMRF of the UPMC Health System
First Posted: May 14, 2007    Key Record Dates
Last Update Posted: February 26, 2009
Last Verified: February 2009

Keywords provided by University of Pittsburgh:
Bipolar Disorder
Menstrual Cycle
Mania or Hypomania

Additional relevant MeSH terms:
Bipolar Disorder
Pathologic Processes
Bipolar and Related Disorders
Mental Disorders