Lilly's Emotional and Physical Symptoms of Depression (LEAPS)
This study has been completed.
Sponsor:
Eli Lilly and Company
Information provided by:
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT00479453
First received: May 25, 2007
Last updated: NA
Last verified: May 2007
History: No changes posted
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Purpose
To assess the effectiveness of duloxetine administered once daily in patients with Major Depressive Disorder in a practice based setting
| Condition | Intervention | Phase |
|---|---|---|
|
Major Depressive Disorder |
Drug: duloxetine hydrochloride |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Lilly's Emotional and Physical Symptoms of Depression |
Resource links provided by NLM:
Further study details as provided by Eli Lilly and Company:
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 and Satisfaction Questionnaire - Short form
| Estimated Enrollment: | 8000 |
| Study Start Date: | August 2004 |
| Study Completion Date: | January 2005 |
To assess physical and emotional symptoms of depressed patients
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Meet criteria for major depressive disorder according to the DSM-IV diagnostic criteria
- Outpatients at lease 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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00479453
Locations
| Puerto Rico | |
| 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 to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | |
| Manati, Puerto Rico | |
Sponsors and Collaborators
Eli Lilly and Company
Investigators
| Study Director: | Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST) | Eli Lilly and Company |
More Information
Additional Information:
No publications provided
| ClinicalTrials.gov Identifier: | NCT00479453 History of Changes |
| Other Study ID Numbers: | 8299, F1J-MC-HMCX |
| Study First Received: | May 25, 2007 |
| Last Updated: | May 25, 2007 |
| Health Authority: | United States: Institutional Review Board |
Additional relevant MeSH terms:
|
Depression Depressive Disorder Depressive Disorder, Major Behavioral Symptoms Mood Disorders Mental Disorders Duloxetine Serotonin Uptake Inhibitors Neurotransmitter Uptake Inhibitors Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action |
Pharmacologic Actions Serotonin Agents Physiological Effects of Drugs Adrenergic Uptake Inhibitors Adrenergic Agents Dopamine Uptake Inhibitors Dopamine Agents Antidepressive Agents Psychotropic Drugs Central Nervous System Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on May 21, 2013