Major Depressive Disorder
Conditions
Keywords
MDD, Escitalopram, Cipralex, Sleep, REM, SWS, Polysomnography
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.
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.
Interventions
DRUGEscitalopram
PROCEDUREA baseline overnight polysomnography (oPSG)
Sponsors
Lundbeck Israel
Sheba Medical Center
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in latency of the first REM episode of the night. | — |
Secondary
| Measure | Time frame |
|---|---|
| Density of rapid eye movements | — |
| Changes of total percentage of REM sleep | — |
| Changes in deep slow wave sleep (SWS) | — |
| Number of night awakenings | — |
Countries
Israel
Contacts
Primary ContactJordan Lewinski, Dr.
Outcome results
None listed