A Study Comparing Duloxetine to Other Antidepressants in the Treatment of Severe Depression

• Status: Completed
• Trial end date: 2009-03-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to compare duloxetine with other antidepressants in the treatment of severe depression.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Eli Lilly and Company
• Collaborator: Boehringer Ingelheim
• Treatments: Citalopram; Dexetimide; Duloxetine Hydrochloride; Fluoxetine; Paroxetine; Sertraline

Criteria

Inclusion criteria:

• At least 18 years of age

• Have major depression and are currently in a severe depressive episode

• Have a degree of understanding such that patient can communicate with the investigator and study staff

• All females must test negative for pregnancy

• Females of childbearing potential must use reliable method of birth control during the study and for 1 month after taking the last dose of study drug

Exclusion criteria:

• Have not responded to duloxetine for depression in the past

• Have a history of bipolar disorder, a psychotic disorder (such as schizophrenia), a cognitive disorder (such as moderate or severe dementia), or obsessive-compulsive disorder (OCD)

• Are at significant risk for suicide

• Have not responded to 2 or more adequate trials of antidepressant medications during the current depressive episode

• Have a serious, unstable medical condition

• Have a current or recent history of substance abuse or dependence

• Have had electroconvulsive therapy (ECT), transcranial magnetic stimulation (rTMS), or vagus nerve stimulation (VNS) in the past year

• Have started psychotherapy within 6 weeks prior to study entry

• Have a serious medical illness or clinically significant laboratory abnormality that is not stabilized or is anticipated, in the judgment of the investigator, to require hospitalization or use of an excluded medication during the course of the study