Escitalopram in Adult Patients With Major Depressive Disorder

Major Depressive Disorder Clinical Trial

Official title:

A Double-blind, Fixed-dose Study of Escitalopram in Adult Patients With Major Depressive Disorder

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00668525
• Other study ID #: SCT-MD-49
• Status: Completed
• Phase: Phase 3
• First received: April 28, 2008
• Last updated: May 7, 2010
• Start date: April 2008

Study information

• Verified date: May 2010
• Source: Forest Laboratories
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 877
• Est. primary completion date: February 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Depressive Disorder, Major
• Major Depressive Disorder

Intervention

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

Locations

Country	Name	City	State
United States	Forest Investigative Site	Arcadia	California
United States	Forest Investigative Site	Atlanta	Georgia
United States	Forest Investigative Site	Austin	Texas
United States	Forest Investigative Site	Baltimore	Maryland
United States	Forest Investigative Site	Bellevue	Washington
United States	Forest Investigative Site	Bradenton	Florida
United States	Forest Investigative Site	Bronx	New York
United States	Forest Investigative Site	Brooklyn	New York
United States	Forest Investigative Site	Canton	Ohio
United States	Forest Investigative Site	Charleston	South Carolina
United States	Forest Investigative Site	Cherry Hill	New Jersey
United States	Forest Investigative Site	Clementon	New Jersey
United States	Forest Investigative Site	Dayton	Ohio
United States	Forest Investigative Site	Denver	Colorado
United States	Forest Investigative Site	Encino	California
United States	Forest Investigative Site	Garden Grove	California
United States	Forest Investigative Site	Glen Burnie	Maryland
United States	Forest Investigative Site	Houston	Texas
United States	Forest Investigative Site	Irvine	California
United States	Forest Investigative Site	Jacksonville	Florida
United States	Forest Investigative Site	Los Alamitos	California
United States	Forest Investigative Site	Media	Pennsylvania
United States	Forest Investigative Site	Memphis	Tennessee
United States	Forest Investigative Site	Memphis	Tennessee
United States	Forest Investigative Site	New York	New York
United States	Forest Investigative Site	New York	New York
United States	Forest Investigative Site	Newton	Kansas
United States	Forest Investigative Site	Okemos	Michigan
United States	Forest Investigative Site	Omaha	Nebraska
United States	Forest Investigative Site	Omaha	Nebraska
United States	Forest Investigative Site	Orlando	Florida
United States	Forest Investigative Site	Overland	Kansas
United States	Forest Investigative Site	Philadelphia	Pennsylvania
United States	Forest Investigative Site	Phoenix	Arizona
United States	Forest Investigative Site	Portland	Oregon
United States	Forest Investigative Site	Richmond	Virginia
United States	Forest Investigative Site	Rockville	Maryland
United States	Forest Investigative Site	Salt Lake City	Utah
United States	Forest Investigative Site	San Antonio	Texas
United States	Forest Investigative Site	Seattle	Washington
United States	Forest Investigative Site	St. Louis	Missouri
United States	Forest Investigative Site	Staten Island	New York
United States	Forest Investigative Site	Washington	District of Columbia
United States	Forest Investigative Site	West Palm Beach	Florida
United States	Forest Investigative Site	Woodstock	Vermont

Sponsors (1)

Lead Sponsor	Collaborator
Forest Laboratories

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change From Baseline in Total Montgomery Asberg Depression Rating Scale (MADRS) at 8 Weeks.	The MADRS is a 10-item clinician-rated scale that was used to assess depressive symptomatology over the patient's prior week. Patients were rated on 10 items designed to assess feelings of sadness, lassitude, pessimism, inner tension, suicidality, reduced sleep or appetite, difficulty concentrating, and lack of interest. Each item was scored on a 7-point Likert scale; a score of 0 indicated the absence of symptoms, and a score of 6 indicated symptoms of maximum severity. The total score range is 0 to 60 (higher score indicates a greater severity of symptoms).	Change from baseline in MADRS total score at week 8	No
Secondary	Change From Baseline in Hamiltion Rating Scale for Depression (HAM-D) at Week 8	The HAMD is a clinician-rated 24-item scale was used to rate the patient's depressive state. It was also used to identify obsessive-compulsive, genital, and somatic symptoms, as well as diurnal variation in the presence of symptoms. Each item was scored on a 3, 4 or 5-point Likert scale. A score of 0 indicated the absence of symptoms, and a score of 2, 3 or 4 indicated symptoms of maximum severity. The total score range is 0 to 74 (higher score indicates a greater depressive state).	Change from baseline in HAM-D at week 8	No