At a glance
ClinicalIndex Comparison RecordPhase 4Completed· 528 enrolled
Drug / intervention
Duloxetine +1 moredrug
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.
A Phase 4, 8-Week, Double-Blind, Randomized, Placebo-Controlled Study Evaluating the Efficacy of Duloxetine 60 mg Once Daily in Outpatients With Major Depressive Disorder and Associated Painful Physical Symptoms
In Brief
A Phase 4 clinical trial evaluating Duloxetine and Placebo for Major Depressive Disorder. Completed, enrolled 528 participants across 37 sites in 6 countries.
Detailed Summary
The purpose of this study is to find out if 60 mg of duloxetine given once a day by mouth for 8 weeks to patients diagnosed with major depressive disorder, who also report associated painful physical symptoms, is better than placebo when treating depression and its associated painful symptoms.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMajor Depressive Disorder
CountriesFrance, Germany, Puerto Rico, Romania, Sweden, United States
Collaborators--
Timeline
Phase 4CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedOct 2009
Enrollment StartNov 2009
Primary CompletionOct 2010
TodayJul 2026
First PostedOct 23, 2009
Enrollment StartNov 1, 2009
Primary CompletionOct 1, 2010
TodayJul 2, 2026
Enrollment to primary: 11 monthsPosted 16.7 years ago
Interventions
Duloxetinedrug
Participants received 30 mg duloxetine once daily (QD) by mouth (po) for 1 week followed by 60 mg QD, po for 7 weeks.
Placebodrug
Participants received placebo QD, po for 8 weeks.