Overview

Escitalopram in Adult Patients With Major Depressive Disorder

Status:
Completed
Trial end date:
1969-12-31
Target enrollment:
0
Participant gender:
All
Summary
This is a short-term study to evaluate the efficacy, safety, and tolerability of escitalopram in adult patients (18 to 65 years of age) with moderate to severe depression. Patients completing the study may be eligible to enter a long-term open-label extension study with escitalopram.
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, Text Revision
(DSM-IV-TR) diagnostic criteria for Major Depressive Disorder.

- The patient's current depressive episode must be at least 8 weeks in duration.

Exclusion Criteria:

- Women who are pregnant, women who will be breastfeeding during the study, and women
with childbearing potential who are not practicing a reliable method of birth control.

- Patients with a history of meeting DSM-IV-TR criteria for: a. any manic or hypomanic
episode; b. schizophrenia or any other psychotic disorder; c. obsessive-compulsive
disorder.

- Patients who are considered a suicide risk

- Patients with a history of seizures (including seizure disorder), stroke, significant
head injury, central nervous system tumors, or any other condition that predisposes
patients to a risk for seizure.