Vilazodone for Menopausal Hot Flashes

Not Applicable

Completed

Brief Summary: This is a pilot study to determine proof in principle that vilazodone, a selective serotonin reuptake inhibitor and 5HT1a agonist, reduces the frequency and severity of menopausal hot flashes relative to placebo. A secondary aim is to evaluate improvement in menopause-related quality of life.

Detailed Description: 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.

Recruitment & Eligibility

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.

Arm && Interventions

Group	Intervention	Description
placebo capsules (sugar pill)	placebo capsules	Placebo capsules matched to the drug dose for 8 weeks
experimental 1	vilazodone	vilazodone (viibryd). 20 mg or 40 mg/day for 8 weeks

Primary Outcome Measures

Name	Time	Method
Daily Diary Ratings of Frequency of Hot Flashes	Week 8.	Hot flash frequency and severity will be recorded daily in the am and pm on a scale of 0 (none) to 3 (severe). The frequency of hot flashes was the number reported.
Daily Diary Ratings of Severity of Hot Flashes	Week 8.	Hot flash severity will be recorded daily in the am and pm on a scale of 0 (none) to 3 (severe). The frequency of hot flashes was the number reported. The severity of hot flashes was rated on a scale of 0 (none) to 3 (severe). 7-day averages were calculated for baseline, week 4 and week 8 and a mean daily score was obtained for analysis. Baseline values were the means of the first 2 screen weeks. Possible range of the severity scale for the daily mean was 0 (none) to 3 (severe).

Secondary Outcome Measures

Name	Time	Method
Menopause-related Quality of Life (MENQOL)	Week 8	The MENQOL is a validated measure to assess the presence and bother of menopausal symptoms. This will be exploratory. Each of 29 items is rated on a scale of 0 to 6 (extremely bothersome). The items are divided into 4 subscales. The item scores are summed in each subscale and means are computed for the 4 subscales. The total score is the sum of the mean subscale scores. Higher scores are more symptomatic.
Percent of Patients With >=50% Reduction in Moderate to Severe Hot Flashes	Percent change from baseline at Week 8	Percent of patients with n \>=50% reduction in frequency of moderate to severe hot flashes calculated from daily diaries