CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 29 enrolled
Drug / intervention
Duloxetinedrug
Likely dose
Duloxetine 30 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01117857
NCT01117857Phase 4Completed
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Duloxetine for Menopausal Depression

Massachusetts General Hospital·interventional·Posted May 6, 2010·Updated Aug 21, 2014

In Brief

A Phase 4 clinical trial evaluating Duloxetine for Depression and 2 related conditions. Completed, enrolled 29 participants across 1 site.

Detailed Summary

The primary objective of the study is to determine if an eight-week intervention with duloxetine significantly reduces depressive symptoms in symptomatic menopausal women. It is hypothesized that an eight-week trial with duloxetine promotes significant improvement in depression symptoms in menopausal women. The secondary aim of the study is to examine if an eight-week intervention with duloxetine significantly reduces vasomotor symptoms in symptomatic menopausal women. It is hypothesized that an eight-week trial with duloxetine promotes significant improvement in vasomotor symptoms in menopausal women.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDepression, Menopause, Vasomotor Symptoms
CountriesUnited States
Collaborators--

Timeline

Phase 4CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedMay 6, 2010
Enrollment StartAug 1, 2009
Primary CompletionJun 1, 2011
TodayJul 2, 2026
Enrollment to primary: 1.8 yearsPosted 16.2 years ago

Interventions

Duloxetinedrug

One-week placebo lead-in, followed by Duloxetine 30 mg per day for one week. After one week on 30 mg, the dosage will be increased 60 mg per day for the remaining 7 weeks of the study.