Vilazodone for Menopausal Hot Flashes

NCT ID: NCT01680900

Last Updated: 2015-01-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 36 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-11-30
• Study Completion Date: 2013-08-31

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.

Conditions

Hot Flushes

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

experimental 1

vilazodone (viibryd). 20 mg or 40 mg/day for 8 weeks

Group Type: EXPERIMENTAL

vilazodone

Intervention Type: DRUG

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.

placebo capsules (sugar pill)

Placebo capsules matched to the drug dose for 8 weeks

Group Type: PLACEBO_COMPARATOR

placebo capsules

Intervention Type: DRUG

placebo capsules matched to drug capsules.

Interventions

vilazodone

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.

Intervention Type: DRUG

placebo capsules

placebo capsules matched to drug capsules.

Intervention Type: DRUG

Other Intervention Names

viibryd

Eligibility 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.

• Minimum Eligible Age: 45 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Forest Laboratories

INDUSTRY

Sponsor Role: collaborator

University of Pennsylvania

OTHER

Sponsor Role: lead

Responsible Party

Ellen Freeman

Research Profesor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ellen W Freeman, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Pennsylvania

Locations

Dept OB/GYN, Mudd Professorship Suite

Philadelphia, Pennsylvania, United States

Countries

United States

Other Identifiers

816164

Identifier Type: -

Identifier Source: org_study_id