Vilazodone for Menopausal Hot Flashes

• Status: Completed
• Trial end date: 2013-08-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Pennsylvania
• Collaborator: Forest Laboratories
• Treatments: Vilazodone Hydrochloride

Criteria

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.