The Safety and Efficacy of Escitalopram in Pediatric Patients With Major Depressive Disorder - Full Text View

Sponsor:	Forest Laboratories
Information provided by:	Forest Laboratories
ClinicalTrials.gov Identifier:	NCT00107120

Purpose

Depression affects approximately 2.5% of children and 8% of adolescents. 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 provide a systematic evaluation of the safety and efficacy of escitalopram in the treatment of depressed pediatric patients, 12 to 17 years of age. Patients completing the study will be eligible to enter an open-label extension study.

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

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	A Double-blind Flexible Dose Study of Escitalopram in Pediatric Patients With Major Depressive Disorder

Resource links provided by NLM:

MedlinePlus related topics: Depression

Drug Information available for: Benzetimide Dexetimide Citalopram hydrobromide Citalopram Escitalopram Escitalopram oxalate

U.S. FDA Resources

Further study details as provided by Forest Laboratories:

Primary Outcome Measures:

Change in Children's Depression Rating Scale - Revised (CDRS-R) Total Score [ Time Frame: Baseline to end of week 8 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Clinical Global Impressions - Improvement [ Time Frame: At end of weeks 1-8 ] [ Designated as safety issue: No ]

Enrollment:	312
Study Start Date:	March 2005
Primary Completion Date:	May 2007 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Escitalopram: Experimental Escitalopram 10mg once daily for three weeks, 10-20mg once daily for up to the remaining 5 weeks	Drug: Escitalopram Escitalopram 10mg per day for three weeks, 10-20mg per day for up to the remaining 5 weeks
2: Placebo Comparator Placebo once daily for up to 8 weeks	Drug: Placebo Placebo once daily for up to 8 weeks

Eligibility

Ages Eligible for Study:	12 Years to 17 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Patient must meet Diagnostic and Statistical Manual, Fourth Edition (DSM-IV) diagnostic criteria for Major Depressive Disorder.
Patient's current depressive episode must be at least 12 weeks in duration
Patient must have a parent or caregiver who must agree to accompany the patient to all clinic visits.

Exclusion Criteria:

Patients who currently meet DSM-IV criteria for:
1. attention deficit-hyperactivity disorder
2. obsessive-compulsive disorder
3. posttraumatic stress disorder
4. bipolar disorder
5. pervasive developmental disorder
6. mental retardation
7. conduct disorder
8. oppositional defiant disorder
Patients who are considered a suicide risk (have active suicidal ideation), who have made a suicide attempt, or who have ever been hospitalized because of a suicide attempt.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00107120

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Locations

United States, California
PCSD - Feighner Research
San Diego, California, United States, 92111
University of California at Davis, MIND Institute, Health Services
Sacramento, California, United States, 95817
UCSD Outpatient Psychiatry Services
San Diego, California, United States, 92103
United States, District of Columbia
Children's National Medical Center
Washington, District of Columbia, United States, 20010
United States, Florida
University of Florida - Child Study Program
Gainesville, Florida, United States, 32610
Janus Center for Psychiatric Research
West Palm Beach, Florida, United States, 33407
Clinical Neuroscience Solutions, Inc.
Jacksonville, Florida, United States, 32216
Kolin Research Group
Winter Park, Florida, United States, 32789
United States, Illinois
Capstone Clinical Research
Libertyville, Illinois, United States, 60048
United States, Indiana
Clinco
Terre Haute, Indiana, United States, 47802
United States, Kansas
Psychiatric Associates
Overland, Kansas, United States, 66211
United States, Maryland
Capitol Clinical Research Associates
Rockville, Maryland, United States, 20852
Pharmasite Research, Inc.
Baltimore, Maryland, United States, 21208
United States, Missouri
St. Charles Psychiatric Associates
St. Charles, Missouri, United States, 63301
United States, Nebraska
Creighton University Medical School, Department of Psychiatry
Omaha, Nebraska, United States, 68131
United States, New Jersey
CNS Research Institute
Clementon, New Jersey, United States, 08021
Pulmonary and Allergy Associates, P. A.
Summit, New Jersey, United States, 07901
United States, North Carolina
North Carolina Neuropsychiatry, PA
Chapel Hill, North Carolina, United States, 27514
United States, Ohio
University Hospitals of Cleveland, Division of Child & Adolescent Psychiatry
Cleveland, Ohio, United States, 44106
University of Cincinnati College of Medicine, Children's Hospital Medical Center
Cincinnati, Ohio, United States, 45229
United States, Oklahoma
IPS Research Company
Oklahoma City, Oklahoma, United States, 73103
United States, Pennsylvania
Drexel University College of Medicine, Friends Hospital
Philadelphia, Pennsylvania, United States, 19124
University of Pennsylvania, Department of Psychiatry, Mood & Anxiety Disorders Section
Philadelphia, Pennsylvania, United States, 19104
United States, Tennessee
Clinical Neuroscience Solutions
Memphis, Tennessee, United States, 38119
United States, Texas
University of Texas Medical Branch, Department of Psychiatry & Behavioral Sciences
Galveston, Texas, United States, 77555
University of Texas Southwestern Medical Center, Center for Pediatric Psychiatry
Dallas, Texas, United States, 75235
United States, Virginia
Brighton Research Group, LLC
Virginia Beach, Virginia, United States, 23452
United States, Washington
Northwest Clinical Research Center
Bellevue, Washington, United States, 98004

Sponsors and Collaborators

Forest Laboratories

Investigators

Study Director:

Daniel Ventura, PhD

Forest Research Institute, a subsidiary of Forest Laboratories, Inc.

More Information

No publications provided by Forest Laboratories

Additional publications automatically indexed to this study by National Clinical Trials Identifier (NCT ID):

Emslie GJ, Ventura D, Korotzer A, Tourkodimitris S. Escitalopram in the treatment of adolescent depression: a randomized placebo-controlled multisite trial. J Am Acad Child Adolesc Psychiatry. 2009 Jul;48(7):721-9.

Responsible Party:	Forest Research Institute, a subsidiary of Forest Laboratories, Inc. ( Anjana Bose, PhD )
Study ID Numbers:	SCT-MD-32
Study First Received:	April 5, 2005
Results First Received:	April 21, 2009
Last Updated:	September 25, 2009
ClinicalTrials.gov Identifier:	NCT00107120 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Forest Laboratories:

Major Depressive Disorder
Depression
Adolescents
Escitalopram
Pediatrics

Additional relevant MeSH terms:

Parasympatholytics
Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Cholinergic Antagonists
Molecular Mechanisms of Pharmacological Action
Anti-Dyskinesia Agents
Physiological Effects of Drugs
Psychotropic Drugs
Antiparkinson Agents
Depressive Disorder, Major
Cholinergic Agents
Pathologic Processes
Mental Disorders
Therapeutic Uses
Dexetimide

Antidepressive Agents, Second-Generation
Antidepressive Agents
Disease
Depression
Depressive Disorder
Serotonin Uptake Inhibitors
Citalopram
Pharmacologic Actions
Behavioral Symptoms
Muscarinic Antagonists
Serotonin Agents
Autonomic Agents
Mood Disorders
Peripheral Nervous System Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on November 25, 2009