CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 514 enrolled
Drug / intervention
Duloxetine +1 moredrug
Likely dose
Not stated in record
Key inclusion· 2
  • ✓Age ≥18 years
  • ✓Diagnosis of major depression with history of prior depressive episodes
Key exclusion· 5
  • ✕Pregnant or breastfeeding
  • ✕History of bipolar disorder, schizophrenia, or other psychotic disorders
  • ✕Serious medical illness (other than depression) or abnormal laboratory result requiring medication/intervention/hospitalization change
  • ✕MAOI use within 14 days prior to start or potential need for MAOI within 5 days after study completion

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

Search/NCT00105989
NCT00105989Phase 3Completed
CompareCT.gov

Duloxetine Versus Placebo in the Prevention of Recurrence of Major Depressive Disorder

Eli Lilly and Company·interventional·Posted Mar 21, 2005·Updated Jul 28, 2009

In Brief

A Phase 3 clinical trial evaluating Duloxetine and placebo for Depressive Disorder, Major. Completed, enrolled 514 participants across 34 sites in 6 countries.

Detailed Summary

The purpose of this study is to assess the efficacy and safety of duloxetine compared with placebo in the prevention of depressive recurrences among patients with recurrent major depressive disorder.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDepressive Disorder, Major
CountriesFrance, Germany, Italy, Russia, Sweden, United States
CollaboratorsBoehringer Ingelheim

Timeline

Phase 3CompletedFinished
20052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedMar 21, 2005
Enrollment StartMar 1, 2005
Primary CompletionJan 1, 2008
TodayJul 2, 2026
Enrollment to primary: 2.8 yearsPosted 21.3 years ago

Interventions

Duloxetinedrug

placebodrug