Overview

Study of Escitalopram in Adult Patients With Major Depressive Disorder

Status:
Completed
Trial end date:
2006-07-01
Target enrollment:
0
Participant gender:
All
Summary
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, safety, and pharmacoeconomics of escitalopram and an active comparator in patients with major depressive disorder.
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Forest Laboratories
Treatments:
Citalopram
Dexetimide
Criteria
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.