Menstrual Effects On Mood Symptoms in Bipolar Disorder

NCT ID: NCT00472615

Last Updated: 2009-02-26

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 45 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2006-08-31
• Study Completion Date: 2008-06-30

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.

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.

Conditions

Bipolar Disorder

Keywords

Bipolar Disorder; Menstrual Cycle; Depression; Mania or Hypomania; Predictor

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

University of Pittsburgh

OTHER

Sponsor Role: lead

Responsible Party

University of Pittsburgh, School of Medicine, Department of Psychiatry

Principal Investigators

Dorothy K Sit, M.D.

Role: PRINCIPAL_INVESTIGATOR

University of Pittsburgh, School of Medicine, Department of Psychiatry

Locations

Magee Womens Hospital, UPMC

Pittsburgh, Pennsylvania, United States

University of Pittsburgh, School of Medicine, Department of Psychiatry

Pittsburgh, Pennsylvania, United States

Countries

United States

Related Links

http://www.wpic.pitt.edu/research/wbhc/studies.shtml

Western Psychiatric Institute and Clinic - Women's Behavioral HealthCARE Research Studies

Other Identifiers

CMRF of the UPMC Health System

Identifier Type: -

Identifier Source: secondary_id

M01RR000056

Identifier Type: NIH

Identifier Source: org_study_id

View Link