Escitalopram and Sleep Architecture in Patients With Major Depressive Disorder

Study Overview
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Brief Summary
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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
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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.

Official Title
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Escitalopram and Sleep Architecture in Patients With Major Depressive Disorder

Conditions
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Major Depressive Disorder

Intervention / Treatment
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* Drug: Escitalopram
* Procedure: A baseline overnight polysomnography (oPSG)


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Escitalopram|nan|
|Procedure: A baseline overnight polysomnography (oPSG)|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in latency of the first REM episode of the night. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Density of rapid eye movements |  |  | 
| Changes of total percentage of REM sleep |  |  | 
| Changes in deep slow wave sleep (SWS) |  |  | 
| Number of night awakenings |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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REM, MDD, Escitalopram, Cipralex, Sleep, SWS, Polysomnography