Back to resultsEvaluation of the Effects of Duloxetine on Norepinephrine
Primary Purpose
Major Depressive Disorder
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Duloxetine
Escitalopram
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Major Depressive Disorder
Eligibility Criteria
Healthy subjects between the ages of 18-65 years are nonsmokers or are willing to refrain from smoking and are not taking concomitant medications which may inhibit or induce CYP1A2 or CYPD6 or is an MAOI.
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 to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
- 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.
Outcomes
Primary Outcome Measures
Concentrations of DHPG and NE in plasma (in sitting and standing positions), urine, and CSF after multiple daily doses (steady state).
Secondary Outcome Measures
Effect of duloxetine versus escitalopram on ex vivo reuptake inhibition of NE and F-hydroxytryptamine (5-HT) in serum and relationship to exposure.
Effect of duloxetine versus escitalopram on heart rate variability.
Ratio of duloxetine exposure in plasma to CSF at steady state.
Relationship between DHPG and NE concentrations and duloxetine exposure in CSF and plasma.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00414323
Brief Title
Evaluation of the Effects of Duloxetine on Norepinephrine
Official Title
Evaluation of the Effects of Duloxetine on Norepinephrine Transporter Inhibition in Healthy Subjects
Study Type
Interventional
2. Study Status
Record Verification Date
June 2007
Overall Recruitment Status
Completed
Study Start Date
November 2006 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
May 2007 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Eli Lilly and Company
4. Oversight
5. Study Description
Brief Summary
The purpose of this study is to evaluate how taking duloxetine 60mg every day affects the transfer of two normal body chemicals, 3,4-dihydroxyphenylglycol (DHPG) and norepinephrine (NE), across cells in blood and cerebrospinal fluid.
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 1
Interventional Study Model
Crossover Assignment
Masking
Single
Allocation
Randomized
Enrollment
35 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Duloxetine
Intervention Type
Drug
Intervention Name(s)
Escitalopram
Intervention Type
Drug
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
Concentrations of DHPG and NE in plasma (in sitting and standing positions), urine, and CSF after multiple daily doses (steady state).
Secondary Outcome Measure Information:
Title
Effect of duloxetine versus escitalopram on ex vivo reuptake inhibition of NE and F-hydroxytryptamine (5-HT) in serum and relationship to exposure.
Title
Effect of duloxetine versus escitalopram on heart rate variability.
Title
Ratio of duloxetine exposure in plasma to CSF at steady state.
Title
Relationship between DHPG and NE concentrations and duloxetine exposure in CSF and plasma.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Healthy subjects between the ages of 18-65 years are nonsmokers or are willing to refrain from smoking and are not taking concomitant medications which may inhibit or induce CYP1A2 or CYPD6 or is an MAOI.
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 9 AM - 5 PM 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 to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
City
Glendale
State/Province
California
ZIP/Postal Code
91206
Country
United States
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 to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
12. IPD Sharing Statement
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Evaluation of the Effects of Duloxetine on Norepinephrine
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