A Study Comparing Duloxetine to Other Antidepressants in the Treatment of Severe Depression (TRY FIRST)

Lilly

Status and phase: Completed; Phase 4

Conditions: Depression

Treatments: Drug: sertraline; Drug: paroxetine; Drug: citalopram; Drug: duloxetine; Drug: fluoxetine

Study type: Interventional

Funder types: Industry

Identifiers

NCT00666757

F1J-US-HMFT (Other Identifier)

11715 (Registry Identifier)

Details and patient eligibility

About

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

Enrollment: 750 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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750 participants in 5 patient groups

duloxetine

Experimental group

Description:

study drug

Treatment:

Drug: duloxetine

citalopram

Active Comparator group

Treatment:

Drug: citalopram

fluoxetine

Active Comparator group

Treatment:

Drug: fluoxetine

paroxetine

Active Comparator group

Treatment:

Drug: paroxetine

sertraline

Active Comparator group

Treatment:

Drug: sertraline