Lilly's Emotional and Physical Symptoms of Depression Study (LEAPS)
LEAPS
2 other identifiers
interventional
8,000
1 country
1
Brief Summary
To assess the effectiveness of duloxetine administered once daily in patients with Major Depressive Disorder in a practice based setting
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4 major-depressive-disorder
Started Aug 2004
Shorter than P25 for phase_4 major-depressive-disorder
1 active site
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
August 1, 2004
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2005
CompletedFirst Submitted
Initial submission to the registry
May 25, 2007
CompletedFirst Posted
Study publicly available on registry
May 28, 2007
CompletedMay 28, 2007
May 1, 2007
May 25, 2007
May 25, 2007
Conditions
Outcome Measures
Primary Outcomes (3)
Clinical Global Impression of Severity
Somatic Symptom Inventory
Depressive Symptomatology-Self Report
Secondary Outcomes (3)
Patient Global Impression of Improvement
Mood and Physical Symptoms in Depression
Quality of Life Enjoyment Satisfaction Questionnaire-Short form
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
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
Indianapolis, Indiana, United States
Related Publications (1)
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.
PMID: 17934551DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9AM - 5PM Eastern time (UTC/GMT - 5 hours, EST)
Eli Lilly and Company
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
May 25, 2007
First Posted
May 28, 2007
Study Start
August 1, 2004
Study Completion
January 1, 2005
Last Updated
May 28, 2007
Record last verified: 2007-05