Official Title: “A Double-Blind, Fixed-Dose Study of Escitalopram in Adult Patients With Major Depressive Disorder”

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.

Study Type: Interventional

Study Design: Treatment, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study

Study Primary Completion Date: April 2009

Intervention(s) in this Clinical Trial

• Drug: Escitalopram
  • Escitalopram low dose, oral administration, once daily dosing for 8 weeks.
• Drug: Placebo
  • Placebo, oral administration, once daily dosing for 8 weeks
• Drug: Escitalopram
  • Escitalopram high dose, oral administration, once daily dosing for 8 weeks

Arms, Groups and Cohorts in this Clinical Trial

• Active Comparator: 2
  • Escitalopram low dose
• Experimental: 3
  • Escitalopram high dose
• Placebo Comparator: 1
  • Placebo

Primary Measures

• Montgomery Asberg Depression Rating Scale (MADRS)
  • Time Frame: Week 8
    Safety Issue?: No

Secondary Measures

• Hamiltion Rating Scale for Depression (HAM-D)
  • Time Frame: Week 8
    Safety Issue?: No

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.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 65 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Forest Laboratories

Overall Clinical Trial Officials and Contacts

Carl Gommoll, MS Study Director Forest Laboratories  

Information obtained from ClinicalTrials.gov on July 02, 2009

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00668525

Study ID Number: SCT-MD-49

ClinicalTrials.gov Identifier: NCT00668525

Health Authority: United States: Food and Drug Administration