Comparison of Escitalopram Combination in Adult Patients With Major Depressive Disorder

Forest Laboratories

Status and phase

Completed

Phase 3

Conditions

Major Depressive Disorder

Treatments

Drug: Escitalopram

Study type

Interventional

Funder types

Industry

Identifiers

NCT00109044

SCT-MD-35

Details and patient eligibility

About

Escitalopram is the S-enantiomer of citalopram. Both escitalopram and citalopram are selective serotonin reuptake inhibitors (SSRIs) and are used to treat depression in adults. This study is designed to evaluate the efficacy and safety of a fixed-dose escitalopram combination relative to its component monotherapies and to placebo in patients with major depressive disorder.

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Patients must meet Diagnostic and Statistical Manual, Fourth Edition (DSM-IV) diagnostic criteria for Major Depressive Disorder.
The patient's current depressive episode must be at least 12 weeks in duration.

Exclusion criteria

Women who are pregnant, women who will be breastfeeding during the study, and women of childbearing potential who are not practicing a reliable method of birth control.
Patients who currently meet DSM-IV criteria for: a. bipolar disorder; b. schizophrenia or any psychotic disorder; c. obsessive-compulsive disorder; d. mental retardation or any pervasive developmental disorder or cognitive disorder.
Patients who are considered a suicide risk.
Patients with a history of seizure disorder, or any history of seizure, stroke, significant head injury, or any other condition that predisposes toward risk of seizure.