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Escitalopram and Sleep Architecture in Patients With Major Depressive Disorder

Primary Purpose

Major Depressive Disorder

Status
Unknown status
Phase
Phase 4
Locations
Israel
Study Type
Interventional
Intervention
Escitalopram
A baseline overnight polysomnography (oPSG)
Sponsored by
Sheba Medical Center
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Major Depressive Disorder focused on measuring MDD, Escitalopram, Cipralex, Sleep, REM, SWS, Polysomnography

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Sheba Medical Center, Department of psychiatryRecruiting

Outcomes

Primary Outcome Measures

Change in latency of the first REM episode of the night.

Secondary Outcome Measures

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

Full Information

First Posted
March 1, 2007
Last Updated
March 1, 2007
Sponsor
Sheba Medical Center
Collaborators
Lundbeck Israel
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1. Study Identification

Unique Protocol Identification Number
NCT00442481
Brief Title
Escitalopram and Sleep Architecture in Patients With Major Depressive Disorder
Official Title
Escitalopram and Sleep Architecture in Patients With Major Depressive Disorder
Study Type
Interventional

2. Study Status

Record Verification Date
March 2007
Overall Recruitment Status
Unknown status
Study Start Date
February 2007 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Sheba Medical Center
Collaborators
Lundbeck Israel

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Major Depressive Disorder
Keywords
MDD, Escitalopram, Cipralex, Sleep, REM, SWS, Polysomnography

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
25 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Escitalopram
Intervention Type
Procedure
Intervention Name(s)
A baseline overnight polysomnography (oPSG)
Primary Outcome Measure Information:
Title
Change in latency of the first REM episode of the night.
Secondary Outcome Measure Information:
Title
Density of rapid eye movements
Title
Changes of total percentage of REM sleep
Title
Changes in deep slow wave sleep (SWS)
Title
Number of night awakenings

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jordan Lewinski, Dr.
Phone
03-5303765
Email
jordan@extopia.co.il
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jordan Lewinski, Dr.
Organizational Affiliation
Sheba Medical Center, Department of psychiatry
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Mark Weiser, Dr.
Organizational Affiliation
Sheba Medical Center, Department of psychiatry
Official's Role
Study Chair
Facility Information:
Facility Name
Sheba Medical Center, Department of psychiatry
City
Tel Hashomer
Country
Israel
Individual Site Status
Recruiting

12. IPD Sharing Statement

Citations:
PubMed Identifier
1386215
Citation
Benca RM, Obermeyer WH, Thisted RA, Gillin JC. Sleep and psychiatric disorders. A meta-analysis. Arch Gen Psychiatry. 1992 Aug;49(8):651-68; discussion 669-70. doi: 10.1001/archpsyc.1992.01820080059010.
Results Reference
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PubMed Identifier
15912558
Citation
Lader M, Andersen HF, Baekdal T. The effect of escitalopram on sleep problems in depressed patients. Hum Psychopharmacol. 2005 Jul;20(5):349-54. doi: 10.1002/hup.694.
Results Reference
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Escitalopram and Sleep Architecture in Patients With Major Depressive Disorder

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