Dose Escalation, Double-Blind Treatment With Duloxetine Hydrochloride Once Daily Dosing for Evaluation of Safety in Major Depression
Protocol F1J-US-HMBY Dose Escalation, Double-Blind Treatment With Duloxetine Hydrochloride Once Daily Dosing for Evaluation of Safety in Major Depression
2 other identifiers
interventional
120
1 country
9
Brief Summary
The Purposes of this Study are to determine: The safety of duloxetine and any side effects that might be associated with it. Whether duloxetine can help patients with major depression. It is possible that information collected during this study will be analyzed by the sponsor in the future to evaluate duloxetine for other possible uses or for other medical or scientific purposes other than those currently proposed. Duloxetine might not have any good effects for you.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3 major-depressive-disorder
Started Jun 2002
Shorter than P25 for phase_3 major-depressive-disorder
9 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2002
CompletedFirst Submitted
Initial submission to the registry
July 31, 2002
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2002
CompletedFirst Posted
Study publicly available on registry
August 5, 2002
CompletedJuly 19, 2006
July 1, 2006
July 31, 2002
July 18, 2006
Conditions
Keywords
Interventions
Eligibility Criteria
You may qualify if:
- You must be at least 18 years old.
- You must be diagnosed with major depressive disorder
- You must be able to visit the doctor's office once a week to once every 2 weeks for a total of 8 weeks.
You may not qualify if:
- You are a woman and are pregnant or breastfeeding.
- You have a current or previous major psychiatric disorder other than depression, such as bipolar disorder, schizophrenia, or other psychotic disorder.
- You have a history of alcohol or drug dependence or abuse within the past 6 months.
- You are allergic to the study drug or you have experienced allergic reactions when taking several medications at once.
- You have a serious medical illness.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (9)
Unknown Facility
Trumbull, Connecticut, United States
Unknown Facility
Lafayette, Indiana, United States
Unknown Facility
Gaithersburg, Maryland, United States
Unknown Facility
Belmont, Massachusetts, United States
Unknown Facility
Omaha, Nebraska, United States
Unknown Facility
Albuquerque, New Mexico, United States
Unknown Facility
Staten Island, New York, United States
Unknown Facility
Salt Lake City, Utah, United States
Unknown Facility
Bellevue, Washington, United States
Related Publications (1)
Wohlreich MM, Mallinckrodt CH, Prakash A, Watkin JG, Carter WP. Duloxetine for the treatment of major depressive disorder: safety and tolerability associated with dose escalation. Depress Anxiety. 2007;24(1):41-52. doi: 10.1002/da.20209.
PMID: 16845641DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
July 31, 2002
First Posted
August 5, 2002
Study Start
June 1, 2002
Study Completion
August 1, 2002
Last Updated
July 19, 2006
Record last verified: 2006-07