Escitalopram in Adult Patients With Major Depressive Disorder

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 Overview

• Status: Completed
• Conditions: Major Depressive Disorder
• Intervention / Treatment: Drug: Escitalopram; Drug: Escitalopram; Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 877
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Phoenix, Arizona, United States, 85016
      • Forest Investigative Site
  • California
    • 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
      • Forest Investigative Site
  • Colorado
    • Denver, Colorado, United States, 80212
      • Forest Investigative Site
  • District of Columbia
    • Washington, District of Columbia, United States, 20016
      • Forest Investigative Site
  • Florida
    • 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
      • Forest Investigative Site
  • Georgia
    • Atlanta, Georgia, United States, 30328
      • Forest Investigative Site
  • Kansas
    • Newton, Kansas, United States, 67114
      • Forest Investigative Site
    • Overland, Kansas, United States, 66221
      • Forest Investigative Site
  • Maryland
    • Baltimore, Maryland, United States, 21208
      • Forest Investigative Site
    • Glen Burnie, Maryland, United States, 21061
      • Forest Investigative Site
    • Rockville, Maryland, United States, 20852
      • Forest Investigative Site
  • Michigan
    • Okemos, Michigan, United States, 48864
      • Forest Investigative Site
  • Missouri
    • St. Louis, Missouri, United States, 63044
      • Forest Investigative Site
  • Nebraska
    • Omaha, Nebraska, United States, 68131
      • Forest Investigative Site
    • Omaha, Nebraska, United States, 68198
      • Forest Investigative Site
  • New Jersey
    • Cherry Hill, New Jersey, United States, 08002
      • Forest Investigative Site
    • Clementon, New Jersey, United States, 08021
      • Forest Investigative Site
  • New York
    • Bronx, New York, United States, 10467
      • Forest Investigative Site
    • Brooklyn, New York, United States, 11235
      • Forest Investigative Site
    • New York, New York, United States, 10021
      • Forest Investigative Site
    • New York, New York, United States, 10024
      • Forest Investigative Site
    • Staten Island, New York, United States, 10312
      • Forest Investigative Site
  • Ohio
    • Canton, Ohio, United States, 44708
      • Forest Investigative Site
    • Dayton, Ohio, United States, 45408
      • Forest Investigative Site
  • Oregon
    • Portland, Oregon, United States, 97210
      • Forest Investigative Site
  • Pennsylvania
    • Media, Pennsylvania, United States, 19063
      • Forest Investigative Site
    • Philadelphia, Pennsylvania, United States, 19107
      • Forest Investigative Site
  • South Carolina
    • Charleston, South Carolina, United States, 29405
      • Forest Investigative Site
  • Tennessee
    • Memphis, Tennessee, United States, 38119
      • Forest Investigative Site
    • Memphis, Tennessee, United States, 38117
      • Forest Investigative Site
  • Texas
    • Austin, Texas, United States, 78756
      • Forest Investigative Site
    • Houston, Texas, United States, 77008
      • Forest Investigative Site
    • San Antonio, Texas, United States, 78229
      • Forest Investigative Site
  • Utah
    • Salt Lake City, Utah, United States, 84107
      • Forest Investigative Site
  • Vermont
    • Woodstock, Vermont, United States, 05091
      • Forest Investigative Site
  • Virginia
    • Richmond, Virginia, United States, 23230
      • Forest Investigative Site
  • Washington
    • Bellevue, Washington, United States, 98004
      • Forest Investigative Site
    • Seattle, Washington, United States, 98104
      • Forest Investigative Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: TRIPLE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
PLACEBO_COMPARATOR: 1; Placebo	Drug: Placebo; Placebo, oral administration, once daily dosing for 8 weeks
ACTIVE_COMPARATOR: 2; Escitalopram low dose	Drug: Escitalopram; Escitalopram low dose, oral administration, once daily dosing for 8 weeks.; Drug: Escitalopram; Escitalopram high dose, oral administration, once daily dosing for 8 weeks
EXPERIMENTAL: 3; Escitalopram high dose	Drug: Escitalopram; Escitalopram low dose, oral administration, once daily dosing for 8 weeks.; Drug: Escitalopram; Escitalopram high dose, oral administration, once daily dosing for 8 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Forest Laboratories

Study record dates

Study Major Dates

• Study Start: April 1, 2008
• Primary Completion (ACTUAL): February 1, 2009

Study Registration Dates

• First Submitted: April 28, 2008
• First Submitted That Met QC Criteria: April 28, 2008
• First Posted (ESTIMATE): April 29, 2008

Study Record Updates

• Last Update Posted (ESTIMATE): May 11, 2010
• Last Update Submitted That Met QC Criteria: May 7, 2010
• Last Verified: May 1, 2010

More Information

Terms related to this study

• Keywords: Depression; Major Depressive Disorder; Escitalopram
• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Pathologic Processes; Mood Disorders; Depression; Depressive Disorder; Disease; Depressive Disorder, Major; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Parasympatholytics; Autonomic Agents; Peripheral Nervous System Agents; Muscarinic Antagonists; Cholinergic Antagonists; Cholinergic Agents; Psychotropic Drugs; Serotonin Uptake Inhibitors; Neurotransmitter Uptake Inhibitors; Membrane Transport Modulators; Serotonin Agents; Antidepressive Agents; Antidepressive Agents, Second-Generation; Antiparkinson Agents; Anti-Dyskinesia Agents; Citalopram; Dexetimide
• Other Study ID Numbers: SCT-MD-49