Escitalopram and Sleep Architecture in Patients With Major Depressive Disorder
Recruitment status was Recruiting
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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 |
- Change in latency of the first REM episode of the night.
- 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 |
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 |
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| Contact: Jordan Lewinski, Dr. | 03-5303765 | jordan@extopia.co.il |
| Israel | |
| Sheba Medical Center, Department of psychiatry | Recruiting |
| Tel Hashomer, Israel | |
| 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:
|
Depressive Disorder Depression Depressive Disorder, Major Mood Disorders Mental Disorders Behavioral Symptoms Dexetimide Citalopram Antiparkinson Agents Anti-Dyskinesia Agents Central Nervous System Agents Therapeutic Uses Pharmacologic Actions Parasympatholytics |
Autonomic Agents Peripheral Nervous System Agents Physiological Effects of Drugs Muscarinic Antagonists Cholinergic Antagonists Cholinergic Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Antidepressive Agents, Second-Generation Antidepressive Agents Psychotropic Drugs Serotonin Uptake Inhibitors Neurotransmitter Uptake Inhibitors Serotonin Agents |
ClinicalTrials.gov processed this record on May 16, 2013