The Safety and Efficacy of Escitalopram in Pediatric Patients With Major Depressive Disorder

Completed · Phase 3 · Has a placebo group

Conditions studied: Major Depressive Disorder

In brief

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.

Key facts

Study ID

NCT00107120

Run by

Forest Laboratories

People needed

312

Starts

2005-03-01

Last updated by the study team

2012-04-06

Who can join

Age: 12 and older, up to 17. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• Patients who currently meet DSM-IV criteria for:
• attention deficit-hyperactivity disorder
• obsessive-compulsive disorder
• posttraumatic stress disorder
• bipolar disorder
• pervasive developmental disorder
• mental retardation
• conduct disorder
• 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.

Where it is running

• 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

Full record on ClinicalTrials.gov

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