Circadian Effects of Escitalopram

• Status: Completed
• Trial end date: 2011-12-01
• Target enrollment: 0
• Participant gender: All

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 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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Oregon Health and Science University
• Collaborator: Forest Laboratories
• Treatments: Citalopram; Dexetimide

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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