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Lilly's Emotional and Physical Symptoms of Depression Study (LEAPS) (LEAPS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00479726
Recruitment Status : Completed
First Posted : May 28, 2007
Last Update Posted : May 28, 2007
Sponsor:
Information provided by:
Eli Lilly and Company

Tracking Information
First Submitted Date  ICMJE May 25, 2007
First Posted Date  ICMJE May 28, 2007
Last Update Posted Date May 28, 2007
Study Start Date  ICMJE August 2004
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE
 (submitted: May 25, 2007)
  • Clinical Global Impression of Severity
  • Somatic Symptom Inventory
  • Depressive Symptomatology-Self Report
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: May 25, 2007)
  • Patient Global Impression of Improvement
  • Mood and Physical Symptoms in Depression
  • Quality of Life Enjoyment Satisfaction Questionnaire-Short form
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Lilly's Emotional and Physical Symptoms of Depression Study (LEAPS)
Official Title  ICMJE Lilly's Emotional and Physical Symptoms of Depression Study
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
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Major Depressive Disorder
Intervention  ICMJE Drug: duloxetine hydrochloride
Study Arms  ICMJE Not Provided
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Enrollment  ICMJE
 (submitted: May 25, 2007)
8000
Original Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE January 2005
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00479726
Other Study ID Numbers  ICMJE 8300
F1J-MC-HMCY
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE Eli Lilly and Company
Collaborators  ICMJE Not Provided
Investigators  ICMJE
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
PRS Account Eli Lilly and Company
Verification Date May 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP