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

Tracking Information

First Received Date ^ICMJE

April 23, 2008

Last Updated Date

March 20, 2009

Start Date ^ICMJE

May 2008

Primary Completion Date

March 2009 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

16-item Quick Inventory of Depressive Symptomatology, QIDS-SR [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00666757 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

17-item Hamilton Depression Rating Scale, HAMD-17 (Mood Measure) [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
QIDS-SR (Mood Outcome Measure) [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Brief Pain Inventory (BPI) (Pain Measure) [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Sheehan Disability Scale (SDS)(Functional Outcome Measure) [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
World Health Organization Health and Work Performance Questionnaire, Clinical Trials 7-Day Version (HPQ)(Work Performance and Cost Outcomes Measure) [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

TRY FIRST: A 12-Week, Randomized, Open-Label Trial of Duloxetine Versus Generic SSRIs in the Treatment of a Severe Depressive Episode

Brief Summary

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

Detailed Description

Study Phase

Phase IV

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Open Label, Uncontrolled, Parallel Assignment, Efficacy Study

Condition ^ICMJE

Depression

Intervention ^ICMJE

Drug: duloxetine
Drug: fluoxetine
Drug: citalopram
Drug: paroxetine
Drug: sertraline

Study Arms / Comparison Groups

Experimental: duloxetine arm
Active Comparator: SSRI group (citalopram, fluoxetine, paroxetine, and sertraline)

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

759

Completion Date

March 2009

Primary Completion Date

March 2009 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00666757

Responsible Party

Chief Medical Officer, Eli Lilly

Study ID Numbers ^ICMJE

11715, F1J-US-HMFT

Study Sponsor ^ICMJE

Eli Lilly and Company

Collaborators ^ICMJE

Boehringer Ingelheim Pharmaceuticals

Investigators ^ICMJE

Study Director:

Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon-Fri 9AM - 5PM Eastern Time (UTC/GMT-5 hours, EST)

Eli Lilly and Company

Information Provided By

Eli Lilly and Company

Verification Date

March 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP