Status:
UNKNOWN
Escitalopram and Sleep Architecture in Patients With Major Depressive Disorder
Lead Sponsor:
Sheba Medical Center
Collaborating Sponsors:
Lundbeck Israel
Conditions:
Major Depressive Disorder
Eligibility:
All Genders
18-65 years
Phase:
PHASE4
Brief Summary
The purpose of this study is to assess the effect of escitalopram on sleep architecture utilizing a prospective design. Hypothesis: Escitalopram will improve REM latency in patients with MDD that hav...
Detailed Description
Disturbance of sleep is a prominent symptom in depressive disorders. Alterations of sleep patterns in depressed patients include insomnia, frequent awakenings, early wake-up and non-refreshing sleep. ...
Eligibility Criteria
Inclusion
- Patients suffering from MDD, excluding a depressive episode of Bipolar Disorder.
- The depressive episode is not secondary to a general medical condition or substance abuse.
- Ages between 18-65 years old.
- Patients receiving other medications must be on a stable dosage for one month before entering the trial, including hypnotics.
- Able to understand and sign an informed consent form.
Exclusion
- Patients suffering from sleep disturbances due to a physical condition (COPD, sleep apnea or essential insomnia preceding the diagnosis of depression).
- Patients suffering from an unstable clinically significant medical condition (cardiovascular, endocrine, nutritional, hepatic, urinary).
- Patients suffering from a malignancy or neuro-degenerative such as Parkinsons' disease
- Patients suffering from a clinically significant psychiatric psychotic disease, as judged by DSM-IV criteria, such as schizophrenia or acute psychosis.
- Patients experiencing severe withdrawal symptoms following a discontinuation of hypnotic drugs, upon entry into the baseline phase.
- History of drug or alcohol dependence within the last year.
Key Trial Info
Start Date :
February 1 2007
Trial Type :
INTERVENTIONAL
End Date :
Estimated Enrollment :
25 Patients enrolled
Trial Details
Trial ID
NCT00442481
Start Date
February 1 2007
Last Update
March 2 2007
Active Locations (1)
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1
Sheba Medical Center, Department of psychiatry
Tel Litwinsky, Israel