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

This study has been completed.
Sponsor:
Information provided by:
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT00191594
First received: September 12, 2005
Last updated: January 24, 2007
Last verified: January 2007
History of Changes

September 12, 2005
January 24, 2007
March 2005
Not Provided
Adverse events
Same as current
Complete list of historical versions of study NCT00191594 on ClinicalTrials.gov 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
Interventional
Phase 3
Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Major Depressive Disorder
Drug: Duloxetine Hydrochloride
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
105
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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Spain
 
NCT00191594
9548, F1J-XM-HMED
Not Provided
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