Escitalopram in Adult Patients With Major Depressive Disorder

This study has been completed.
Sponsor:
Information provided by:
Forest Laboratories
ClinicalTrials.gov Identifier:
NCT00668525
First received: April 28, 2008
Last updated: May 7, 2010
Last verified: May 2010
  Purpose

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.


Condition Intervention Phase
Major Depressive Disorder
Drug: Escitalopram
Drug: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Double-blind, Fixed-dose Study of Escitalopram in Adult Patients With Major Depressive Disorder

Resource links provided by NLM:


Further study details as provided by Forest Laboratories:

Primary Outcome Measures:
  • Change From Baseline in Total Montgomery Asberg Depression Rating Scale (MADRS) at 8 Weeks. [ Time Frame: Change from baseline in MADRS total score at week 8 ] [ Designated as safety issue: No ]
    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).


Secondary Outcome Measures:
  • Change From Baseline in Hamiltion Rating Scale for Depression (HAM-D) at Week 8 [ Time Frame: Change from baseline in HAM-D at week 8 ] [ Designated as safety issue: No ]
    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).


Enrollment: 877
Study Start Date: April 2008
Primary Completion Date: February 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 2
Escitalopram low dose
Drug: Escitalopram
Escitalopram low dose, oral administration, once daily dosing for 8 weeks.
Experimental: 3
Escitalopram high dose
Drug: Escitalopram
Escitalopram high dose, oral administration, once daily dosing for 8 weeks
Placebo Comparator: 1
Placebo
Drug: Placebo
Placebo, oral administration, once daily dosing for 8 weeks

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00668525

  Hide Study Locations
Locations
United States, Arizona
Forest Investigative Site
Phoenix, Arizona, United States, 85016
United States, California
Forest Investigative Site
Arcadia, California, United States, 91007
Forest Investigative Site
Encino, California, United States, 91316
Forest Investigative Site
Garden Grove, California, United States, 92845
Forest Investigative Site
Irvine, California, United States, 92618
Forest Investigative Site
Los Alamitos, California, United States, 90720
United States, Colorado
Forest Investigative Site
Denver, Colorado, United States, 80212
United States, District of Columbia
Forest Investigative Site
Washington, District of Columbia, United States, 20016
United States, Florida
Forest Investigative Site
Bradenton, Florida, United States, 34208
Forest Investigative Site
Jacksonville, Florida, United States, 32216
Forest Investigative Site
Orlando, Florida, United States, 32806
Forest Investigative Site
West Palm Beach, Florida, United States, 33407
United States, Georgia
Forest Investigative Site
Atlanta, Georgia, United States, 30328
United States, Kansas
Forest Investigative Site
Newton, Kansas, United States, 67114
Forest Investigative Site
Overland, Kansas, United States, 66221
United States, Maryland
Forest Investigative Site
Baltimore, Maryland, United States, 21208
Forest Investigative Site
Glen Burnie, Maryland, United States, 21061
Forest Investigative Site
Rockville, Maryland, United States, 20852
United States, Michigan
Forest Investigative Site
Okemos, Michigan, United States, 48864
United States, Missouri
Forest Investigative Site
St. Louis, Missouri, United States, 63044
United States, Nebraska
Forest Investigative Site
Omaha, Nebraska, United States, 68131
Forest Investigative Site
Omaha, Nebraska, United States, 68198
United States, New Jersey
Forest Investigative Site
Cherry Hill, New Jersey, United States, 08002
Forest Investigative Site
Clementon, New Jersey, United States, 08021
United States, New York
Forest Investigative Site
Bronx, New York, United States, 10467
Forest Investigative Site
Brooklyn, New York, United States, 11235
Forest Investigative Site
New York, New York, United States, 10024
Forest Investigative Site
New York, New York, United States, 10021
Forest Investigative Site
Staten Island, New York, United States, 10312
United States, Ohio
Forest Investigative Site
Canton, Ohio, United States, 44708
Forest Investigative Site
Dayton, Ohio, United States, 45408
United States, Oregon
Forest Investigative Site
Portland, Oregon, United States, 97210
United States, Pennsylvania
Forest Investigative Site
Media, Pennsylvania, United States, 19063
Forest Investigative Site
Philadelphia, Pennsylvania, United States, 19107
United States, South Carolina
Forest Investigative Site
Charleston, South Carolina, United States, 29405
United States, Tennessee
Forest Investigative Site
Memphis, Tennessee, United States, 38119
Forest Investigative Site
Memphis, Tennessee, United States, 38117
United States, Texas
Forest Investigative Site
Austin, Texas, United States, 78756
Forest Investigative Site
Houston, Texas, United States, 77008
Forest Investigative Site
San Antonio, Texas, United States, 78229
United States, Utah
Forest Investigative Site
Salt Lake City, Utah, United States, 84107
United States, Vermont
Forest Investigative Site
Woodstock, Vermont, United States, 05091
United States, Virginia
Forest Investigative Site
Richmond, Virginia, United States, 23230
United States, Washington
Forest Investigative Site
Bellevue, Washington, United States, 98004
Forest Investigative Site
Seattle, Washington, United States, 98104
Sponsors and Collaborators
Forest Laboratories
Investigators
Study Director: Carl Gommoll, MS Forest Laboratories
  More Information

No publications provided

Responsible Party: Carl Gommoll, Study Director, Forest Laboratories
ClinicalTrials.gov Identifier: NCT00668525     History of Changes
Other Study ID Numbers: SCT-MD-49
Study First Received: April 28, 2008
Results First Received: March 22, 2010
Last Updated: May 7, 2010
Health Authority: United States: Food and Drug Administration

Keywords provided by Forest Laboratories:
Depression
Major Depressive Disorder
Escitalopram

Additional relevant MeSH terms:
Depressive Disorder
Depression
Depressive Disorder, Major
Mood Disorders
Mental Disorders
Behavioral Symptoms
Dexetimide
Citalopram
Antiparkinson Agents
Anti-Dyskinesia Agents
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Parasympatholytics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Muscarinic Antagonists
Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Serotonin Agents

ClinicalTrials.gov processed this record on April 17, 2014