The Safety and Efficacy of Escitalopram in Pediatric Patients With Major Depressive Disorder
NCT ID: NCT00107120
Last Updated: 2012-04-06
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
312 participants
INTERVENTIONAL
2005-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Escitalopram
Escitalopram 10mg once daily for three weeks, 10-20mg once daily for up to the remaining 5 weeks
Escitalopram
Escitalopram 10mg per day for three weeks, 10-20mg per day for up to the remaining 5 weeks
2
Placebo once daily for up to 8 weeks
Placebo
Placebo once daily for up to 8 weeks
Interventions
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Escitalopram
Escitalopram 10mg per day for three weeks, 10-20mg per day for up to the remaining 5 weeks
Placebo
Placebo once daily for up to 8 weeks
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
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.
12 Years
17 Years
ALL
No
Sponsors
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Forest Laboratories
INDUSTRY
Responsible Party
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Principal Investigators
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Daniel Ventura, PhD
Role: STUDY_DIRECTOR
Forest Research Institute, a subsidiary of Forest Laboratories, Inc.
Locations
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University of California at Davis, MIND Institute, Health Services
Sacramento, California, United States
UCSD Outpatient Psychiatry Services
San Diego, California, United States
PCSD - Feighner Research
San Diego, California, United States
Children's National Medical Center
Washington D.C., District of Columbia, United States
University of Florida - Child Study Program
Gainesville, Florida, United States
Clinical Neuroscience Solutions, Inc.
Jacksonville, Florida, United States
Janus Center for Psychiatric Research
West Palm Beach, Florida, United States
Kolin Research Group
Winter Park, Florida, United States
Capstone Clinical Research
Libertyville, Illinois, United States
Clinco
Terre Haute, Indiana, United States
Psychiatric Associates
Overland, Kansas, United States
Pharmasite Research, Inc.
Baltimore, Maryland, United States
Capitol Clinical Research Associates
Rockville, Maryland, United States
St. Charles Psychiatric Associates
Saint Charles, Missouri, United States
Creighton University Medical School, Department of Psychiatry
Omaha, Nebraska, United States
CNS Research Institute
Clementon, New Jersey, United States
Pulmonary and Allergy Associates, P. A.
Summit, New Jersey, United States
North Carolina Neuropsychiatry, PA
Chapel Hill, North Carolina, United States
University of Cincinnati College of Medicine, Children's Hospital Medical Center
Cincinnati, Ohio, United States
University Hospitals of Cleveland, Division of Child & Adolescent Psychiatry
Cleveland, Ohio, United States
IPS Research Company
Oklahoma City, Oklahoma, United States
University of Pennsylvania, Department of Psychiatry, Mood & Anxiety Disorders Section
Philadelphia, Pennsylvania, United States
Drexel University College of Medicine, Friends Hospital
Philadelphia, Pennsylvania, United States
Clinical Neuroscience Solutions
Memphis, Tennessee, United States
University of Texas Southwestern Medical Center, Center for Pediatric Psychiatry
Dallas, Texas, United States
University of Texas Medical Branch, Department of Psychiatry & Behavioral Sciences
Galveston, Texas, United States
Brighton Research Group, LLC
Virginia Beach, Virginia, United States
Northwest Clinical Research Center
Bellevue, Washington, United States
Countries
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References
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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):721-729. doi: 10.1097/CHI.0b013e3181a2b304.
Other Identifiers
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SCT-MD-32
Identifier Type: -
Identifier Source: org_study_id
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