Comparison of Escitalopram Combination in Adult Patients With Major Depressive Disorder

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Forest Laboratories
ClinicalTrials.gov Identifier:
NCT00109044
First received: April 22, 2005
Last updated: March 1, 2012
Last verified: March 2012
  Purpose

Escitalopram is the S-enantiomer of citalopram. Both escitalopram and citalopram are selective serotonin reuptake inhibitors (SSRIs) and are used to treat depression in adults. This study is designed to evaluate the efficacy and safety of a fixed-dose escitalopram combination relative to its component monotherapies and to placebo in patients with major depressive disorder.


Condition Intervention Phase
Major Depressive Disorder
Drug: Escitalopram
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: Fixed Dose Comparison of Escitalopram Combination in Adult Patients With Major Depressive Disorder

Resource links provided by NLM:


Further study details as provided by Forest Laboratories:

Primary Outcome Measures:
  • Montgomery Asberg Depression Rating Scale (MADRS)

Secondary Outcome Measures:
  • Hamilton Depression Rating Scale (HAMD)

Estimated Enrollment: 540
Study Start Date: March 2005
Study Completion Date: May 2006
Primary Completion Date: May 2006 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients must meet Diagnostic and Statistical Manual, Fourth Edition (DSM-IV) diagnostic criteria for Major Depressive Disorder.
  • The patient's current depressive episode must be at least 12 weeks in duration.

Exclusion Criteria:

  • Women who are pregnant, women who will be breastfeeding during the study, and women of childbearing potential who are not practicing a reliable method of birth control.
  • Patients who currently meet DSM-IV criteria for: a. bipolar disorder; b. schizophrenia or any psychotic disorder; c. obsessive-compulsive disorder; d. mental retardation or any pervasive developmental disorder or cognitive disorder.
  • Patients who are considered a suicide risk.
  • Patients with a history of seizure disorder, or any history of seizure, stroke, significant head injury, or any other condition that predisposes toward risk of seizure.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00109044

Locations
United States, Arizona
Southwest Health, Ltd
Phoenix, Arizona, United States, 85016
United States, Colorado
Alpine Clinical Research
Boulder, Colorado, United States, 80304
Radiant Research, Inc.
Denver, Colorado, United States, 80212
United States, Florida
Clinical Neuroscience Solutions, Inc.
Orlando, Florida, United States, 32806
United States, Illinois
Cunningham Clinical Research, LLC
Edwardsville, Illinois, United States, 62025
Midwest Center for Neurobiological Medicine
Oakbrook Terrace, Illinois, United States, 60181
United States, Maryland
Capital Clinical Research Associates
Rockville, Maryland, United States, 20852
United States, Michigan
Summit Research Network (Michigan), Inc.
Okemos, Michigan, United States, 48864
United States, New Jersey
CNS Research Institute
Clementon, New Jersey, United States, 08021
Center for Emotional Fitness
Moorestown, New Jersey, United States, 08057
United States, New York
Eastside Comprehensive Medical Center
New York, New York, United States, 10021
United States, North Carolina
Piedmont Medical Research Associates, Inc.
Winston-Salem, North Carolina, United States, 27103
United States, Tennessee
Clinical Neuroscience Solutions, Inc.
Memphis, Tennessee, United States, 38119
United States, Texas
Claghorn-Lesem Research Clinic
Bellaire, Texas, United States, 77401
Croft Group Research Center
San Antonio, Texas, United States, 78229
United States, Virginia
Dominion Clinical Research
Midlothian, Virginia, United States, 23112-3989
United States, Washington
Northwest Clinical Research Center
Bellevue, Washington, United States, 98004
Summit Research Network (Seattle), LLC
Seattle, Washington, United States, 98104
Sponsors and Collaborators
Forest Laboratories
  More Information

No publications provided

Responsible Party: Forest Laboratories
ClinicalTrials.gov Identifier: NCT00109044     History of Changes
Other Study ID Numbers: SCT-MD-35
Study First Received: April 22, 2005
Last Updated: March 1, 2012
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
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Serotonin Agents
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs

ClinicalTrials.gov processed this record on August 28, 2014