Escitalopram and Sleep Architecture in Patients With Major Depressive Disorder

NCT00442481 | Unknown Phase 4

• 1 other identifier: SHEBA-06-4205-JL-CTIL
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

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.

Conditions

Major Depressive Disorder

Keywords

MDD; Escitalopram; Cipralex; Sleep; REM; SWS; Polysomnography

Outcome Measures

Primary Outcomes (1)

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

Secondary Outcomes (4)

• Density of rapid eye movements

• Changes of total percentage of REM sleep

• Changes in deep slow wave sleep (SWS)

• Number of night awakenings

Interventions

Escitalopram DRUG

A baseline overnight polysomnography (oPSG) PROCEDURE

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sheba Medical Center: lead
• Lundbeck Israel: collaborator

Study Sites (1)

Sheba Medical Center, Department of psychiatry

Tel Litwinsky, Israel

RECRUITING

Related Publications (2)

• 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.

  PMID: 1386215 BACKGROUND

• 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.

  PMID: 15912558 BACKGROUND

MeSH Terms

Conditions

Depressive Disorder, Major

Interventions

Escitalopram

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Propylamines; Amines; Organic Chemicals; Nitriles; Benzofurans; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Jordan Lewinski, Dr.

  Sheba Medical Center, Department of psychiatry

  PRINCIPAL INVESTIGATOR

• Mark Weiser, Dr.

  Sheba Medical Center, Department of psychiatry

  STUDY CHAIR

Central Study Contacts

Jordan Lewinski, Dr.

CONTACT

03-5303765; jordan@extopia.co.il

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV

Study Record Dates

• First Submitted: March 1, 2007
• First Posted: March 2, 2007
• Study Start: February 1, 2007
• Last Updated: March 2, 2007

Record last verified: 2007-03

Locations

IL (1)