search
Back to results

Dose Escalation, Double-Blind Treatment With Duloxetine Hydrochloride Once Daily Dosing for Evaluation of Safety in Major Depression

Primary Purpose

Major Depressive Disorder

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Duloxetine
Sponsored by
Eli Lilly and Company
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Major Depressive Disorder focused on measuring Sad, blue, lack of energy, depressed, hopelessness, guilt

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: 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. Exclusion Criteria: 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.

Sites / Locations

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
July 31, 2002
Last Updated
July 18, 2006
Sponsor
Eli Lilly and Company
search

1. Study Identification

Unique Protocol Identification Number
NCT00042575
Brief Title
Dose Escalation, Double-Blind Treatment With Duloxetine Hydrochloride Once Daily Dosing for Evaluation of Safety in Major Depression
Official Title
Protocol F1J-US-HMBY Dose Escalation, Double-Blind Treatment With Duloxetine Hydrochloride Once Daily Dosing for Evaluation of Safety in Major Depression
Study Type
Interventional

2. Study Status

Record Verification Date
July 2006
Overall Recruitment Status
Completed
Study Start Date
June 2002 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
August 2002 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Eli Lilly and Company

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Major Depressive Disorder
Keywords
Sad, blue, lack of energy, depressed, hopelessness, guilt

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
120 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Duloxetine

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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.
Facility Information:
City
Trumbull
State/Province
Connecticut
Country
United States
City
Lafayette
State/Province
Indiana
Country
United States
City
Gaithersburg
State/Province
Maryland
Country
United States
City
Belmont
State/Province
Massachusetts
Country
United States
City
Omaha
State/Province
Nebraska
Country
United States
City
Albuquerque
State/Province
New Mexico
Country
United States
City
Staten Island
State/Province
New York
Country
United States
City
Salt Lake City
State/Province
Utah
Country
United States
City
Bellevue
State/Province
Washington
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
16845641
Citation
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.
Results Reference
derived

Learn more about this trial

Dose Escalation, Double-Blind Treatment With Duloxetine Hydrochloride Once Daily Dosing for Evaluation of Safety in Major Depression

We'll reach out to this number within 24 hrs