Back to resultsLilly's Emotional and Physical Symptoms of Depression Study (LEAPS) (LEAPS)
Primary Purpose
Major Depressive Disorder
Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
duloxetine hydrochloride
Sponsored by
About this trial
This is an interventional treatment trial for Major Depressive Disorder
Eligibility Criteria
Inclusion criteria:
- Meet criteria for major depressive disorder according to the DSM-IV diagnostic criteria
- Outpatients at least 18 years of age
- Sign the informed consent
- All females must test negative for a urine pregnancy test at visit 1. Females of child bearing potential must agree to utilize medically acceptable and reliable means of birth control
- Have a level of understanding sufficient to communicate with the investigator and are able to complete all patient self-rated scales in the study
Exclusion Criteria:
- Are investigator site personnel directly affiliated with the study or immediate family
- Are employed by Eli Lilly and Company
- Have received treatment within the last 30 days or are currently enrolled in a study with a drug that has not received regulatory approval for any indication at time of study entry
- Current substance dependence, excluding nicotine and caffeine
- Treatment with a monoamine oxidase inhibitor within 14 days prior to visit 1 or potential need to use an MAOI within 5 days after discontinuation of study drug
- Acute liver injury or severe (Child-Pugh Class C) cirrhosis
Sites / Locations
- 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 - 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician
Outcomes
Primary Outcome Measures
Clinical Global Impression of Severity
Somatic Symptom Inventory
Depressive Symptomatology-Self Report
Secondary Outcome Measures
Patient Global Impression of Improvement
Mood and Physical Symptoms in Depression
Quality of Life Enjoyment Satisfaction Questionnaire-Short form
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00479726
Brief Title
Lilly's Emotional and Physical Symptoms of Depression Study (LEAPS)
Acronym
LEAPS
Official Title
Lilly's Emotional and Physical Symptoms of Depression Study
Study Type
Interventional
2. Study Status
Record Verification Date
May 2007
Overall Recruitment Status
Completed
Study Start Date
August 2004 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
January 2005 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Eli Lilly and Company
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
To assess the effectiveness of duloxetine administered once daily in patients with Major Depressive Disorder in a practice based setting
Detailed Description
To assess physical and emotional symptoms of depressed patients
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Major Depressive Disorder
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
8000 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
duloxetine hydrochloride
Primary Outcome Measure Information:
Title
Clinical Global Impression of Severity
Title
Somatic Symptom Inventory
Title
Depressive Symptomatology-Self Report
Secondary Outcome Measure Information:
Title
Patient Global Impression of Improvement
Title
Mood and Physical Symptoms in Depression
Title
Quality of Life Enjoyment Satisfaction Questionnaire-Short form
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion criteria:
Meet criteria for major depressive disorder according to the DSM-IV diagnostic criteria
Outpatients at least 18 years of age
Sign the informed consent
All females must test negative for a urine pregnancy test at visit 1. Females of child bearing potential must agree to utilize medically acceptable and reliable means of birth control
Have a level of understanding sufficient to communicate with the investigator and are able to complete all patient self-rated scales in the study
Exclusion Criteria:
Are investigator site personnel directly affiliated with the study or immediate family
Are employed by Eli Lilly and Company
Have received treatment within the last 30 days or are currently enrolled in a study with a drug that has not received regulatory approval for any indication at time of study entry
Current substance dependence, excluding nicotine and caffeine
Treatment with a monoamine oxidase inhibitor within 14 days prior to visit 1 or potential need to use an MAOI within 5 days after discontinuation of study drug
Acute liver injury or severe (Child-Pugh Class C) cirrhosis
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9AM - 5PM Eastern time (UTC/GMT - 5 hours, EST)
Organizational Affiliation
Eli Lilly and Company
Official's Role
Study Director
Facility Information:
Facility Name
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 - 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician
City
Indianapolis
State/Province
Indiana
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
17934551
Citation
Wohlreich MM, Wiltse CG, Desaiah D, Ye W, Robinson RL, Kroenke K, Kornstein SG, Greist JH. Duloxetine in practice-based clinical settings: assessing effects on the emotional and physical symptoms of depression in an open-label, multicenter study. Prim Care Companion J Clin Psychiatry. 2007;9(4):271-9. doi: 10.4088/pcc.v09n0404.
Results Reference
derived
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Lilly's Emotional and Physical Symptoms of Depression Study (LEAPS)
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