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Sponsors and Collaborators: |
Sheba Medical Center Lundbeck Israel |
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Information provided by: | Sheba Medical Center |
ClinicalTrials.gov Identifier: | NCT00442481 |
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 |
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Major Depressive Disorder |
Drug: Escitalopram Procedure: A baseline overnight polysomnography (oPSG) |
Phase IV |
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 |
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.
Ages Eligible for Study: | 18 Years to 65 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
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 |
Study ID Numbers: | SHEBA-06-4205-JL-CTIL |
Study First Received: | March 1, 2007 |
Last Updated: | March 1, 2007 |
ClinicalTrials.gov Identifier: | NCT00442481 History of Changes |
Health Authority: | Israel: Israeli Health Ministry Pharmaceutical Administration |
MDD Escitalopram Cipralex Sleep |
REM SWS Polysomnography |
Neurotransmitter Agents Depression Cholinergic Antagonists Psychotropic Drugs Depressive Disorder, Major Depressive Disorder Cholinergic Agents Serotonin Uptake Inhibitors Citalopram |
Serotonin Behavioral Symptoms Muscarinic Antagonists Mental Disorders Mood Disorders Peripheral Nervous System Agents Antidepressive Agents, Second-Generation Dexetimide Antidepressive Agents |
Parasympatholytics Neurotransmitter Uptake Inhibitors Neurotransmitter Agents Cholinergic Antagonists Molecular Mechanisms of Pharmacological Action Anti-Dyskinesia Agents Physiological Effects of Drugs Psychotropic Drugs Antiparkinson Agents Depressive Disorder, Major Cholinergic Agents Pathologic Processes Mental Disorders Therapeutic Uses Dexetimide |
Antidepressive Agents, Second-Generation Antidepressive Agents Disease Depression Depressive Disorder Serotonin Uptake Inhibitors Citalopram Pharmacologic Actions Behavioral Symptoms Muscarinic Antagonists Serotonin Agents Autonomic Agents Mood Disorders Peripheral Nervous System Agents Central Nervous System Agents |