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

Sponsors and Collaborators:	Eli Lilly and Company Boehringer Ingelheim Pharmaceuticals
Information provided by:	Eli Lilly and Company
ClinicalTrials.gov Identifier:	NCT00666757

Purpose

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

Condition	Intervention	Phase
Depression	Drug: duloxetine Drug: fluoxetine Drug: citalopram Drug: paroxetine Drug: sertraline	Phase IV

MedlinePlus related topics: Antidepressants Depression

Drug Information available for: Sertraline hydrochloride Sertraline Fluoxetine Escitalopram Benzetimide Citalopram Citalopram hydrobromide Dexetimide Escitalopram oxalate Paroxetine Paroxetine hydrochloride Paroxetine Mesylate Duloxetine Duloxetine hydrochloride Fluoxetine hydrochloride

U.S. FDA Resources

Study Type:

Interventional

Study Design:

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

Official Title:

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

Further study details as provided by Eli Lilly and Company:

Primary Outcome Measures:

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

Secondary Outcome Measures:

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 ]

Estimated Enrollment:

740

Study Start Date:

May 2008

Estimated Study Completion Date:

December 2009

Estimated Primary Completion Date:

December 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental duloxetine arm	Drug: duloxetine 30-120mg orally daily for 12 weeks
2: Active Comparator SSRI group (citalopram, fluoxetine, paroxetine, and sertraline)	Drug: fluoxetine 20-80mg orally daily for 12 weeks Drug: citalopram 20-40mg orally daily for 12 weeks Drug: paroxetine 20-50mg orally daily for 12 weeks Drug: sertraline 50-200mg orally daily for 12 weeks

Eligibility

Ages Eligible for Study:

18 Years and older

Genders Eligible for Study:

Both

Accepts Healthy Volunteers:

No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00666757

Show 61 Study Locations

Sponsors and Collaborators

Eli Lilly and Company

Boehringer Ingelheim Pharmaceuticals

Investigators

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

More Information

Lilly Clinical Trial Registry This link exits the ClinicalTrials.gov site

Responsible Party:

Eli Lilly ( Chief Medical Officer )

Study ID Numbers:

11715, F1J-US-HMFT

First Received:

April 23, 2008

Last Updated:

December 5, 2008

ClinicalTrials.gov Identifier:

NCT00666757

Health Authority:

United States: Institutional Review Board

Keywords provided by Eli Lilly and Company:

Severe Depressive Episode

Study placed in the following topic categories:

Depression
Depressive Disorder
Citalopram
Paroxetine
Duloxetine
Serotonin
Behavioral Symptoms

Fluoxetine
Dopamine
Mental Disorders
Mood Disorders
Sertraline
Dexetimide

Additional relevant MeSH terms:

Dopamine Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Adrenergic Agents
Molecular Mechanisms of Pharmacological Action
Adrenergic Uptake Inhibitors
Physiological Effects of Drugs
Psychotropic Drugs

Serotonin Uptake Inhibitors
Pharmacologic Actions
Serotonin Agents
Therapeutic Uses
Dopamine Agents
Antidepressive Agents, Second-Generation
Central Nervous System Agents
Antidepressive Agents

ClinicalTrials.gov processed this record on January 07, 2009