Vilazodone for Menopausal Hot Flashes

This is a proposal to conduct a small clinical trial for proof in principle that vilazodone reduces the frequency and severity of menopausal hot flashes. An additional exploratory aim is to identify improvement in menopause-related quality of life. Healthy, perimenopausal women ages 45-60 with an average of 4 or more moderate or severe hot flashes/night sweats per day for 3 screening weeks will be randomized to 8 weeks of treatment in a 2:1 ratio of vilazodone or matching placebo pills. Flexible dosing of vilazodone will start at 10 mg once/day for 7 days, increase to 20 mg/day for 1 more week and increase to 40 mg once/day at week 3 if unimproved. The primary outcome assessments are the frequency and severity of hot flashes at week 4 and week 8 as assessed by prospective daily diaries (using 7-day mean scores from the daily diaries). The secondary outcome is clinical improvement, defined as hot flash frequency >=50% decrease from baseline. Treatment-emergent adverse events will be monitored and patient ratings of tolerability will be obtained.

Inclusion criteria

• Women ages 45-60 years
• Amenorrhea for 60 days or more or postmenopausal or bi-lateral oophorectomy.
• 4 or more moderate or severe hot flashes or night sweats per 24 hour period (28/week) as recorded on daily diaries in 3 screening weeks.
• Hot flashes/night sweats rated as moderate to severe and/or bothersome (moderately to a lot) on 4 or more days/nights in each screen week.
• In general good health.
• Signed informed consent.

Exclusion criteria

• Psychotropic medications currently or within the last 30 days.
• Current use of hormonal medications such as hormone therapy or hormonal contraception or any treatment for hot flashes (Prescription, over-the-counter or herbal).
• Drug or alcohol abuse in the past year.
• Lifetime diagnosis of psychosis or bipolar disorder.
• Suicide attempt in the past 3 years or any current suicidal ideation.
• Current major depression.
• Not using a medically approved, non-hormonal method of birth control if sexually active and not postmenopausal (12 or more months since last menstrual period or bi-lateral oophorectomy).
• Pregnancy, intending pregnancy or breast feeding.
• Any severe of unstable medical illness, e.g., breast or ovarian cancer, seizure disorders, etc.
• Current participation in another intervention study.
• Inability or unwillingness to complete study procedures.