Status:
COMPLETED
Circadian Effects of Escitalopram
Lead Sponsor:
Oregon Health and Science University
Collaborating Sponsors:
Forest Laboratories
Conditions:
Depression
Eligibility:
All Genders
18-65 years
Phase:
NA
Brief Summary
The goal of the study is to obtain preliminary data that will test whether the antidepressant medication escitalopram resets the body clock: a collection of nerve cells in the brain that control the t...
Detailed Description
Background: The human biological clock (circadian pacemaker) has long been thought to play a role in non-seasonal depression. A connection is suggested by the demonstration of 24-hour rhythms in mood,...
Eligibility Criteria
Inclusion
- 18-65 years old
- able to comply with requirements of the experimental protocol
- competent to sign informed consent
- have mild to severe major depressive disorder without psychotic features and without a seasonal pattern
- currently be under the care of a licensed mental health care provider or primary care physician
- Score \> 7 when interviewed by a trained rater using the 21-Item Hamilton Depression Scale (HAM-D)
- be in good physical health
- not be suicidal
- not be taking any other antidepressant medications besides escitalopram during the study
- be free of antidepressant medications for 2-4 weeks prior to beginning the study
- not have a history of transmeridian travel or shift work in the past 2 months and have no plans for transmeridian travel or shift work for the duration of the study
- be able to maintain a regular sleep wake schedule for the weeks one and nine of study
- women of childbearing potential must have a negative pregnancy test and practice an acceptable method of birth control
Exclusion
- abnormal heart, liver, or kidney function
- significant laboratory abnormalities on Complete Blood Count, Complete Metabolic Set, Thyroid Stimulating Hormone, EKG, \& urinalysis
- shift work or transmeridian travel in the last 2 months
- current use of melatonin
- evidence of a primary sleep disorder by history
- women who are pregnant or lactating
- be taking medications with known sedative or stimulating effects or that would interfere with the production of melatonin
Key Trial Info
Start Date :
May 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2011
Estimated Enrollment :
19 Patients enrolled
Trial Details
Trial ID
NCT01214044
Start Date
May 1 2008
End Date
December 1 2011
Last Update
August 20 2019
Active Locations (1)
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1
Oregon Health & Science University
Portland, Oregon, United States, 97239