Procedures
This study conducted an observational longitudinalevaluation of mood for 4 months during each of the following menopausal stages: late reproductive, early menopausal transition, late menopausal transition,and early postmenopause (defined in the “Menopausal status” section below) in women with bipolar disorder.
The initial interview was scheduled in the early follicular phase on days 2–6 of the menstrual cycle (day 1 being the first day of menstruation) in women who were menstruating more frequently than every 60 days for standardized hormonal assessments.
Initial visit included a standardized interview with the Affective Disorder Evaluation (ADE), a modified version of the mood and psychosis modules from the Structured Clinical Interview for DSM Disorders (SCID) intended for routine use by practicing clinicians, which was performed by an ADE trained psychiatrist.
The ADE provided diagnoses of DSM IV bipolar I disorder, bipolar II disorder, bipolar disorder not otherwise specified,psychiatric and medical comorbidities, as well as mood disorder history.
The ADE includes standardized questions for subject report of the percent of time in the prior 12 months spent experiencing mood elevation,depression, or anhedonia symptoms.
It also asks for patient self-reported endorsement of a history of premenstrual or postpartum mood exacerbation. Assessments of current mood state severity with Young Mania Rating Scale (YMRS) and Montgomery-Asberg Depression Rating Scale (MADRS) were performed by two trained raters who periodically compared score results for inter-rater reliability. Subjects completed
self-administered questionnaires detailing menstrual and medical history and the Greene Climacteric Scale to assess menopausal symptoms.
A blood sample was obtained in the early follicular phase of the menstrual cycle to assess follicle-stimulating hormone (FSH) and estradiol levels. In women who had not menstruated for 60 days or longer, a random hormonal sample was assessed