Vilazodone for Menopausal Hot Flashes

Study Overview
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Brief Summary
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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
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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.

Official Title
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Vilazodone for Menopausal Hot Flashes: A Proof in Principle Study

Conditions
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Hot Flushes

Intervention / Treatment
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* Drug: vilazodone
* Drug: placebo capsules


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 45 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: experimental 1<br>vilazodone (viibryd). 20 mg or 40 mg/day for 8 weeks | Drug: vilazodone<br>* capsules once/day for 8 weeks. Dose starts at 10 mg for 7 days, increases to 20 mg/day for 7 days, increases to 40 mg/day at week 3 of unimproved.<br>* Other names: viibryd;|
| Placebo Comparator: placebo capsules (sugar pill)<br>Placebo capsules matched to the drug dose for 8 weeks | Drug: placebo capsules<br>* placebo capsules matched to drug capsules.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Daily Diary Ratings of Frequency of Hot Flashes | 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. | Week 8. | 
| Daily Diary Ratings of Severity of Hot Flashes | 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). | Week 8. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent of Patients With >=50% Reduction in Moderate to Severe Hot Flashes | Percent of patients with n >=50% reduction in frequency of moderate to severe hot flashes calculated from daily diaries | Percent change from baseline at Week 8 | 
| Menopause-related Quality of Life (MENQOL) | 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. | Week 8 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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menopause, hot flashes, vilazodone