Viewing Study NCT00442481



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Study NCT ID: NCT00442481
Status: UNKNOWN
Last Update Posted: 2007-03-02
First Post: 2007-03-01

Brief Title: Escitalopram and Sleep Architecture in Patients With Major Depressive Disorder
Sponsor: Sheba Medical Center
Organization: Sheba Medical Center

Study Overview

Official Title: Escitalopram and Sleep Architecture in Patients With Major Depressive Disorder
Status: UNKNOWN
Status Verified Date: 2007-03
Last Known Status: RECRUITING
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
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 have responded clinically to treatment
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 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

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: None
Is a FDA Regulated Device?: None
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None