Menstrual Effects On Mood Symptoms in Bipolar Disorder

This study has been completed.
Sponsor:
Information provided by:
University of Pittsburgh
ClinicalTrials.gov Identifier:
NCT00472615
First received: May 10, 2007
Last updated: February 25, 2009
Last verified: February 2009
  Purpose

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
Bipolar Disorder

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Menstrual Effects On Mood Symptoms in Bipolar Disorder

Resource links provided by NLM:


Further study details as provided by University of Pittsburgh:

Biospecimen Retention:   Samples Without DNA

whole blood


Estimated Enrollment: 45
Study Start Date: August 2006
Study Completion Date: June 2008
Primary Completion Date: June 2008 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Community sample and outpatient psychiatric offices

Criteria

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
  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: NCT00472615

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

No publications provided

Responsible Party: Dorothy Sit, M.D., Assistant Professor of Psychiatry, University of Pittsburgh, School of Medicine, Department of Psychiatry
ClinicalTrials.gov Identifier: NCT00472615     History of Changes
Other Study ID Numbers: M01-RR-000056, CMRF of the UPMC Health System
Study First Received: May 10, 2007
Last Updated: February 25, 2009
Health Authority: United States: Institutional Review Board

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

Additional relevant MeSH terms:
Bipolar Disorder
Affective Disorders, Psychotic
Mood Disorders
Mental Disorders

ClinicalTrials.gov processed this record on September 14, 2014