NCT Number: NCT00191594
Open-Label Duloxetine Extension Phase in Patients Who Have Completed Previous Duloxetine Trials
A study in patients with depression
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Notify MeKey information
Conditions
Age range
18 year and older
Sex eligibility
All sexes
Study type
Interventional
Phase
Phase 3
Primary location
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., Barcelona, Spain
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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
Treatment and study plan
Primary outcomes
-
Adverse events
Secondary outcomes
-
Vital signs
Sponsors and collaborators
Lead sponsor
Eli Lilly and Company
Industry
Registry information
Official study title
Open-Label Duloxetine Extension Phase in Patients Who Have Completed the HMDG Clinical Trial
Important dates
- Study start
- 2005
- Study completion
- 2006
- First posted
- Sep 19, 2005
- Registry last updated
- Jan 26, 2007
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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