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Escitalopram and Sleep Architecture in Patients With Major Depressive Disorder
This study is currently recruiting participants.
Study NCT00442481   Information provided by Sheba Medical Center
First Received: March 1, 2007   No Changes Posted

March 1, 2007
March 1, 2007
February 2007
 
Change in latency of the first REM episode of the night.
Same as current
No Changes Posted
  • Density of rapid eye movements
  • Changes of total percentage of REM sleep
  • Changes in deep slow wave sleep (SWS)
  • Number of night awakenings
Same as current
 
Escitalopram and Sleep Architecture in Patients With Major Depressive Disorder
Escitalopram and Sleep Architecture in Patients With Major Depressive Disorder

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 have responded clinically to treatment.

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. Polysomnographic recordings have confirmed these reports, reporting reduced latency of the first REM episode of the night, with decreased density of rapid eye movements, and enhancement of total percentage of REM sleep, a reduction of deep slow wave sleep (SWS) and increase in night awakenings (Benca et al., Classification of sleep disorders).

The effects of antidepressant drugs on depression and sleep disorders, specifically SSRIs, have been thoroughly researched. The effects of escitalopram on sleep in depressed patients have been reported using a retrospective design, and in this proposed protocol, we suggest to assess the effect of escitalopram on sleep architecture utilizing a prospective design.

Hypothesis:

Escitalopram will improve REM latency in patients with MDD that have responded clinically to treatment.

Phase IV
Interventional
Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study
Major Depressive Disorder
  • Drug: Escitalopram
  • Procedure: A baseline overnight polysomnography (oPSG)
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Recruiting
25
 
 

Inclusion Criteria:

  • 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 Criteria:

  • 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.
Both
18 Years to 65 Years
No
Contact: Jordan Lewinski, Dr. 03-5303765 jordan@extopia.co.il
Israel
 
NCT00442481
 
SHEBA-06-4205-JL-CTIL
Sheba Medical Center
Lundbeck Israel
Principal Investigator: Jordan Lewinski, Dr. Sheba Medical Center, Department of psychiatry
Study Chair: Mark Weiser, Dr. Sheba Medical Center, Department of psychiatry
Sheba Medical Center
March 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP