Escitalopram and Sleep Architecture in Patients With Major Depressive Disorder
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|ClinicalTrials.gov Identifier: NCT00442481|
Recruitment Status : Unknown
Verified March 2007 by Sheba Medical Center.
Recruitment status was: Recruiting
First Posted : March 2, 2007
Last Update Posted : March 2, 2007
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.
|Condition or disease||Intervention/treatment||Phase|
|Major Depressive Disorder||Drug: Escitalopram Procedure: A baseline overnight polysomnography (oPSG)||Phase 4|
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.
Escitalopram will improve REM latency in patients with MDD that have responded clinically to treatment.
|Study Type :||Interventional (Clinical Trial)|
|Enrollment :||25 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Escitalopram and Sleep Architecture in Patients With Major Depressive Disorder|
|Study Start Date :||February 2007|
- Change in latency of the first REM episode of the night.
- Density of rapid eye movements
- Changes of total percentage of REM sleep
- Changes in deep slow wave sleep (SWS)
- Number of night awakenings
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00442481
|Contact: Jordan Lewinski, Dr.||firstname.lastname@example.org|
|Sheba Medical Center, Department of psychiatry||Recruiting|
|Tel Hashomer, Israel|
|Principal Investigator:||Jordan Lewinski, Dr.||Sheba Medical Center, Department of psychiatry|
|Study Chair:||Mark Weiser, Dr.||Sheba Medical Center, Department of psychiatry|