Escitalopram in Adult Patients With Major Depressive Disorder
A Double-blind, Fixed-dose Study of Escitalopram in Adult Patients With Major Depressive Disorder
1 other identifier
interventional
877
1 country
45
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3 major-depressive-disorder
45 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2008
CompletedFirst Submitted
Initial submission to the registry
April 28, 2008
CompletedFirst Posted
Study publicly available on registry
April 29, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2009
CompletedResults Posted
Study results publicly available
May 6, 2010
CompletedMay 11, 2010
May 1, 2010
10 months
April 28, 2008
March 22, 2010
May 7, 2010
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Secondary Outcomes (1)
Change From Baseline in Hamiltion Rating Scale for Depression (HAM-D) at Week 8
Change from baseline in HAM-D at week 8
Study Arms (3)
2
ACTIVE COMPARATOREscitalopram low dose
3
EXPERIMENTALEscitalopram high dose
1
PLACEBO COMPARATORPlacebo
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (45)
Forest Investigative Site
Phoenix, Arizona, 85016, United States
Forest Investigative Site
Arcadia, California, 91007, United States
Forest Investigative Site
Encino, California, 91316, United States
Forest Investigative Site
Garden Grove, California, 92845, United States
Forest Investigative Site
Irvine, California, 92618, United States
Forest Investigative Site
Los Alamitos, California, 90720, United States
Forest Investigative Site
Denver, Colorado, 80212, United States
Forest Investigative Site
Washington D.C., District of Columbia, 20016, United States
Forest Investigative Site
Bradenton, Florida, 34208, United States
Forest Investigative Site
Jacksonville, Florida, 32216, United States
Forest Investigative Site
Orlando, Florida, 32806, United States
Forest Investigative Site
West Palm Beach, Florida, 33407, United States
Forest Investigative Site
Atlanta, Georgia, 30328, United States
Forest Investigative Site
Newton, Kansas, 67114, United States
Forest Investigative Site
Overland, Kansas, 66221, United States
Forest Investigative Site
Baltimore, Maryland, 21208, United States
Forest Investigative Site
Glen Burnie, Maryland, 21061, United States
Forest Investigative Site
Rockville, Maryland, 20852, United States
Forest Investigative Site
Okemos, Michigan, 48864, United States
Forest Investigative Site
St Louis, Missouri, 63044, United States
Forest Investigative Site
Omaha, Nebraska, 68131, United States
Forest Investigative Site
Omaha, Nebraska, 68198, United States
Forest Investigative Site
Cherry Hill, New Jersey, 08002, United States
Forest Investigative Site
Clementon, New Jersey, 08021, United States
Forest Investigative Site
Brooklyn, New York, 11235, United States
Forest Investigative Site
New York, New York, 10021, United States
Forest Investigative Site
New York, New York, 10024, United States
Forest Investigative Site
Staten Island, New York, 10312, United States
Forest Investigative Site
The Bronx, New York, 10467, United States
Forest Investigative Site
Canton, Ohio, 44708, United States
Forest Investigative Site
Dayton, Ohio, 45408, United States
Forest Investigative Site
Portland, Oregon, 97210, United States
Forest Investigative Site
Media, Pennsylvania, 19063, United States
Forest Investigative Site
Philadelphia, Pennsylvania, 19107, United States
Forest Investigative Site
Charleston, South Carolina, 29405, United States
Forest Investigative Site
Memphis, Tennessee, 38117, United States
Forest Investigative Site
Memphis, Tennessee, 38119, United States
Forest Investigative Site
Austin, Texas, 78756, United States
Forest Investigative Site
Houston, Texas, 77008, United States
Forest Investigative Site
San Antonio, Texas, 78229, United States
Forest Investigative Site
Salt Lake City, Utah, 84107, United States
Forest Investigative Site
Woodstock, Vermont, 05091, United States
Forest Investigative Site
Richmond, Virginia, 23230, United States
Forest Investigative Site
Bellevue, Washington, 98004, United States
Forest Investigative Site
Seattle, Washington, 98104, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Carl Gommoll, MS
- Organization
- Forest Research Institute, a subsidiary of Forest Laboratories, Inc.
Study Officials
- STUDY DIRECTOR
Carl Gommoll, MS
Forest Laboratories
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
April 28, 2008
First Posted
April 29, 2008
Study Start
April 1, 2008
Primary Completion
February 1, 2009
Last Updated
May 11, 2010
Results First Posted
May 6, 2010
Record last verified: 2010-05