Escitalopram and Sleep Architecture in Patients With Major Depressive Disorder

Major Depressive Disorder Clinical Trial

Official title:

Escitalopram and Sleep Architecture in Patients With Major Depressive Disorder

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00442481
• Other study ID #: SHEBA-06-4205-JL-CTIL
• Status: Recruiting
• Phase: Phase 4
• First received: March 1, 2007
• Last updated: March 1, 2007
• Start date: February 2007

Study information

• Verified date: March 2007
• Source: Sheba Medical Center
• Contact: Jordan Lewinski, Dr.
• Phone: 03-5303765
• Email: jordan[@]extopia.co.il
• Is FDA regulated: No
• Health authority: Israel: Israeli Health Ministry Pharmaceutical Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 25
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Depressive Disorder, Major
• Major Depressive Disorder

Intervention

Drug:
• Escitalopram

Procedure:
• A baseline overnight polysomnography (oPSG)

Locations

Country	Name	City	State
Israel	Sheba Medical Center, Department of psychiatry	Tel Hashomer

Sponsors (2)

Lead Sponsor	Collaborator
Sheba Medical Center	Lundbeck Israel

Country where clinical trial is conducted

Israel, 

References & 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in latency of the first REM episode of the night.
Secondary	Density of rapid eye movements
Secondary	Changes of total percentage of REM sleep
Secondary	Changes in deep slow wave sleep (SWS)
Secondary	Number of night awakenings