Full Text View
Tabular View
No Study Results Posted
Related Studies
A Study Comparing Duloxetine to Other Antidepressants in the Treatment of Severe Depression (TRY FIRST)
This study has been completed.
Study NCT00666757   Information provided by Eli Lilly and Company
First Received: April 23, 2008   Last Updated: March 20, 2009   History of Changes

April 23, 2008
March 20, 2009
May 2008
March 2009   (final data collection date for primary outcome measure)
16-item Quick Inventory of Depressive Symptomatology, QIDS-SR [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00666757 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
 
A Study Comparing Duloxetine to Other Antidepressants in the Treatment of Severe Depression
TRY FIRST: A 12-Week, Randomized, Open-Label Trial of Duloxetine Versus Generic SSRIs in the Treatment of a Severe Depressive Episode

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

 
Phase IV
Interventional
Treatment, Randomized, Open Label, Uncontrolled, Parallel Assignment, Efficacy Study
Depression
  • Drug: duloxetine
  • Drug: fluoxetine
  • Drug: citalopram
  • Drug: paroxetine
  • Drug: sertraline
  • Experimental: duloxetine arm
  • Active Comparator: SSRI group (citalopram, fluoxetine, paroxetine, and sertraline)
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Completed
759
March 2009
March 2009   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00666757
Chief Medical Officer, Eli Lilly
11715, F1J-US-HMFT
Eli Lilly and Company
Boehringer Ingelheim Pharmaceuticals
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
Eli Lilly and Company
March 2009

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