Methods
Study participants
Study enrollment occurred from January 2010 to July 2012, and subjects were recruited from the community as well as from an academic psychiatry clinic.
Eligibility included (a) a diagnosis of bipolar disorder(I, II, NOS) based on DSM IV criteria, (b) age 40–60 years with intact uterus and ovaries, (c) a menstrual period within the last 5 years, if menstruating regularly(every 21–35 days) subject must be experiencing menopausal symptoms, and (d) having a current psychiatric provider. Menopausal symptoms were defined
narrowly as vasomotor symptoms (hot flashes and night sweats) so as not to overlap with mood symptoms(for example, sleep disturbance and irritability).
As study personnel did not assume care of subjects,for subject safety, a psychiatric provider was required.
Women using vaginal hormone therapy (n = 1) or intrauterine device with hormonal progesterone (n = 1) were accepted; those on oral contraceptives were not. Participants provided signed, written informed consent prior to study entry