Open-Label Duloxetine Extension Phase in Patients Who Have Completed Previous Duloxetine Trials

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00191594
Recruitment Status : Completed
First Posted : September 19, 2005
Last Update Posted : January 26, 2007
Information provided by:
Eli Lilly and Company

September 12, 2005
September 19, 2005
January 26, 2007
March 2005
Not Provided
Adverse events
Same as current
Complete list of historical versions of study NCT00191594 on Archive Site
Vital signs
Same as current
Not Provided
Not Provided
Open-Label Duloxetine Extension Phase in Patients Who Have Completed Previous Duloxetine Trials
Open-Label Duloxetine Extension Phase in Patients Who Have Completed the HMDG Clinical Trial
A study in patients with depression
Not Provided
Phase 3
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Major Depressive Disorder
Drug: Duloxetine Hydrochloride
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Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Same as current
August 2006
Not Provided

Inclusion Criteria:

  • Male or female patients at least 18 years of age who have previously completed satisfactorily the Lilly sponsored previous clinical trial, and who are clinically controlled with Duloxetine, as judge by the investigator
  • All females must test negative for a urine pregnancy test at Visit 1. Females of childbearing potential (not surgically sterilized and between menarche and 1 year postmenopausal) must agree to utilize medically acceptable and reliable means of birth control as determined by the investigator during the study. Women who are pregnant or breast-feeding may not participate in the study.
  • Must sign the informed consent document (ICD).

Exclusion Criteria:

  • Have received treatment within the last 30 days with a drug ( not including study drug) that has not received regulatory approval for any indication at the time of study entry.
  • Patients who have entered the optional tapering period of the previous study.
  • In the opinion of the investigator, patients judged to be at serious suicidal risk.
  • Treatment with a MAOI within 14 days prior to Visit 1 or potential need to use MAOI during the study or within 5 days of discontinuation of the study drug.
  • Any patient who previously experienced a serious adverse event while taking duloxetine unless approved by the Lilly Physician
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
Not Provided
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Not Provided
Eli Lilly and Company
Not Provided
Study Director: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT- 5 hours, EST) Eli Lilly and Company
Eli Lilly and Company
January 2007

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