Circadian Effects of Escitalopram

Completed · Not applicable · Has a placebo group

Conditions studied: Depression

In brief

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 timing of many body processes. The study will also test whether the improvement in depression symptoms with escitalopram correlates with the degree to which the timing of the body clock is properly aligned with the timing of sleep.

Key facts

Study ID

NCT01214044

Run by

Oregon Health and Science University

People needed

19

Starts

2008-05-01

Expected to finish

2011-12-01

Last updated by the study team

2019-08-20

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Oregon Health & Science University — Portland, Oregon, United States

Full record on ClinicalTrials.gov

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