Prior failure to respond to escitalopram therapy for depression.Any abnormal pre-study laboratory values that require clinical intervention.Use of prescription and non-prescription sedative drugs given for the purpose of sleep induction or to relieve jet lag.Currently using a benzodiazepine or SSRI or more than 2 days of use within the 28 days preceding randomization.History of mania, manic episode or bipolar disease.History of a suicide attempt or suicidal ideation.

Severity of depressive episode had been rated as 'severe' or 'severe with psychotic features.'.Subject must be stabilized on all ongoing long-term medication therapy for at least 28 days prior to screening visit.Women must use a medically acceptable form of contraception (steroidal contraceptive, double-barrier, or intra-uterine device) during the entire study period, or: be surgically sterilized, post-menopausal, agree to use double-barrier contraception throughout the study period, or must have a negative urine pregnancy test prior to randomization.Must be either newly diagnosed or show symptoms of relapse/recurrence of depression while not on medication.Must have QIDS-SR16 score between 6 and 15.Must meet the diagnostic requirements for Major Depressive Disorder.Must experience sleep disturbances at least 3 nights/week, based on historical data.Why Should I Register and Submit Results?.

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