Status:
COMPLETED
A Comparison of Tolerability and Efficacy of Different Doses of Duloxetine for the Treatment of Major Depressive Disorder
Lead Sponsor:
Eli Lilly and Company
Conditions:
Depressive Disorder
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
The purpose of this study is to compare the tolerability and efficacy of different doses of duloxetine in patients with major depressive disorder.
Eligibility Criteria
Inclusion
- Outpatients at least 18 years of age (male and/or female) who meet criteria for major depressive disorder (MDD) as defined by the Diagnostic and Statistical Manual for Mental Disorders Fourth Edition Text Revision (DSM-IV-TR). Patients may have comorbid Anxiety Disorders, except for Obsessive Compulsive Disorder
- Tests negative for pregnancy at the time of enrollment based on a serum pregnancy test and agrees to use a reliable method of birth control (for example, use of oral contraceptives or Norplant a reliable barrier method of birth control diaphragms with contraceptive jelly; cervical caps with contraceptive jelly; condoms with contraceptive foam; intrauterine devices; partner with vasectomy; or abstinence) during the study and for 1 month following the last dose of study drug.
- Hamilton Depression Rating 17 Item Scale (HAMD-17) greater than 15 at Visits 1 and 2.
Exclusion
- Have any current Axis I disorder other than major depressive disorder (MDD), dysthymia, or any anxiety disorder; however, obsessive-compulsive disorder is excluded.
- Have any previous or current diagnosis of bipolar disorder, obsessive-compulsive disorder, schizophrenia, or other psychotic disorders.
- Lack of response of the current episode of major depression to two or more adequate courses of antidepressant therapy at clinically appropriate dose for a minimum of 4 weeks or, in the judgment of the investigator, the patient meets criteria for treatment-resistant depression.
- DSM-IV-TR-defined history of substance abuse or dependence within the past 6 months, excluding nicotine and caffeine.
- Patients judged to be at serious suicidal risk in the opinion of the investigator.
Key Trial Info
Start Date :
October 1 2004
Trial Type :
INTERVENTIONAL
End Date :
January 1 2006
Estimated Enrollment :
640 Patients enrolled
Trial Details
Trial ID
NCT00191061
Start Date
October 1 2004
End Date
January 1 2006
Last Update
January 26 2007
Active Locations (32)
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1
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon-Fri from 9AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Little Rock, Arkansas, United States
2
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon-Fri from 9AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Coral Springs, Florida, United States
3
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon-Fri from 9AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Jacksonville, Florida, United States
4
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon-Fri from 9AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Miami, Florida, United States