Escitalopram and Sleep Architecture in Patients With Major Depressive Disorder - Full Text View

Sponsors and Collaborators:	Sheba Medical Center Lundbeck Israel
Information provided by:	Sheba Medical Center
ClinicalTrials.gov Identifier:	NCT00442481

Purpose

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	Intervention	Phase
Major Depressive Disorder	Drug: Escitalopram Procedure: A baseline overnight polysomnography (oPSG)	Phase IV

MedlinePlus related topics: Depression

Drug Information available for: Escitalopram Benzetimide Citalopram Citalopram hydrobromide Dexetimide Escitalopram oxalate BaseLine

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study
Official Title:	Escitalopram and Sleep Architecture in Patients With Major Depressive Disorder

Further study details as provided by Sheba Medical Center:

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

Estimated Enrollment:	25
Study Start Date:	February 2007

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.

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00442481

Contacts

Contact: Jordan Lewinski, Dr.

03-5303765

jordan@extopia.co.il

Locations

Israel
Sheba Medical Center, Department of psychiatry	Recruiting
Tel Hashomer, Israel

Sponsors and Collaborators

Sheba Medical Center

Lundbeck Israel

Investigators

Principal Investigator:	Jordan Lewinski, Dr.	Sheba Medical Center, Department of psychiatry
Study Chair:	Mark Weiser, Dr.	Sheba Medical Center, Department of psychiatry

More Information

Publications:

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.

Lader M, Andersen HF, Baekdal T. The effect of escitalopram on sleep problems in depressed patients. Hum Psychopharmacol. 2005 Jul;20(5):349-54.

Study ID Numbers:	SHEBA-06-4205-JL-CTIL
Study First Received:	March 1, 2007
Last Updated:	March 1, 2007
ClinicalTrials.gov Identifier:	NCT00442481
Health Authority:	Israel: Israeli Health Ministry Pharmaceutical Administration

Keywords provided by Sheba Medical Center:

MDD
Escitalopram
Cipralex
Sleep

REM
SWS
Polysomnography

Study placed in the following topic categories:

Depression
Mental Disorders
Mood Disorders
Depressive Disorder, Major
Dexetimide

Depressive Disorder
Citalopram
Serotonin
Behavioral Symptoms

Additional relevant MeSH terms:

Parasympatholytics
Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Disease
Molecular Mechanisms of Pharmacological Action
Cholinergic Antagonists
Anti-Dyskinesia Agents
Physiological Effects of Drugs
Psychotropic Drugs
Antiparkinson Agents
Cholinergic Agents

Serotonin Uptake Inhibitors
Pharmacologic Actions
Muscarinic Antagonists
Serotonin Agents
Pathologic Processes
Autonomic Agents
Therapeutic Uses
Peripheral Nervous System Agents
Antidepressive Agents, Second-Generation
Central Nervous System Agents
Antidepressive Agents

ClinicalTrials.gov processed this record on January 16, 2009