Escitalopram and Sleep Architecture in Patients With Major Depressive Disorder

Phase 4

• Conditions: Major Depressive Disorder

• Registration Number: NCT00442481
• Lead Sponsor: Sheba Medical Center

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 Timeline

• Study Start: 2007-02
• Status Verified: 2007-03
• Study First Submitted: 2007-03-01
• Study First Submitted QC: 2007-03-01
• Last Update Submitted: 2007-03-01
• Study First Posted: 2007-03-02
• Last Update Posted: 2007-03-02

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Change in latency of the first REM episode of the night.

Secondary Outcome Measures

Name	Time	Method
Density of rapid eye movements
Changes of total percentage of REM sleep
Changes in deep slow wave sleep (SWS)
Number of night awakenings

Trial Locations

Locations (1)

Sheba Medical Center, Department of psychiatry; 🇮🇱 Tel Hashomer, Israel