Escitalopram and Sleep Architecture in Patients With Major Depressive Disorder

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2007 by Sheba Medical Center.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Lundbeck Israel
Information provided by:
Sheba Medical Center
ClinicalTrials.gov Identifier:
NCT00442481
First received: March 1, 2007
Last updated: NA
Last verified: March 2007
History: No changes posted
  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 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Escitalopram and Sleep Architecture in Patients With Major Depressive Disorder

Resource links provided by NLM:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Keywords provided by Sheba Medical Center:
MDD
Escitalopram
Cipralex
Sleep
REM
SWS
Polysomnography

Additional relevant MeSH terms:
Depression
Depressive Disorder
Depressive Disorder, Major
Disease
Behavioral Symptoms
Mental Disorders
Mood Disorders
Pathologic Processes
Citalopram
Dexetimide
Anti-Dyskinesia Agents
Antidepressive Agents
Antidepressive Agents, Second-Generation
Antiparkinson Agents
Autonomic Agents
Central Nervous System Agents
Cholinergic Agents
Cholinergic Antagonists
Molecular Mechanisms of Pharmacological Action
Muscarinic Antagonists
Neurotransmitter Agents
Neurotransmitter Uptake Inhibitors
Parasympatholytics
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Psychotropic Drugs
Serotonin Agents
Serotonin Uptake Inhibitors
Therapeutic Uses

ClinicalTrials.gov processed this record on October 20, 2014