Overview

Escitalopram and Sleep Architecture in Patients With Major Depressive Disorder

Status:
Unknown status
Trial end date:
1969-12-31
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 4
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Sheba Medical Center
Collaborator:
Lundbeck Israel
Treatments:
Citalopram
Dexetimide
Criteria
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.