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

Last updated: April 4, 2012
Sponsor: Forest Laboratories
Overall Status: Completed

Phase

3

Condition

Depression

Depression (Major/severe)

Mood Disorders

Treatment

N/A

Clinical Study ID

NCT00107120
SCT-MD-32
  • Ages 12-17
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

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 allclinic visits.

Exclusion

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 havemade a suicide attempt, or who have ever been hospitalized because of a suicideattempt.

Study Design

Total Participants: 312
Study Start date:
March 01, 2005
Estimated Completion Date:

Connect with a study center

  • University of California at Davis, MIND Institute, Health Services

    Sacramento, California 95817
    United States

    Site Not Available

  • PCSD - Feighner Research

    San Diego, California 92111
    United States

    Site Not Available

  • UCSD Outpatient Psychiatry Services

    San Diego, California 92103
    United States

    Site Not Available

  • Children's National Medical Center

    Washington, District of Columbia 20010
    United States

    Site Not Available

  • University of Florida - Child Study Program

    Gainesville, Florida 32610
    United States

    Site Not Available

  • Clinical Neuroscience Solutions, Inc.

    Jacksonville, Florida 32216
    United States

    Site Not Available

  • Janus Center for Psychiatric Research

    West Palm Beach, Florida 33407
    United States

    Site Not Available

  • Kolin Research Group

    Winter Park, Florida 32789
    United States

    Site Not Available

  • Capstone Clinical Research

    Libertyville, Illinois 60048
    United States

    Site Not Available

  • Clinco

    Terre Haute, Indiana 47802
    United States

    Site Not Available

  • Psychiatric Associates

    Overland, Kansas 66211
    United States

    Site Not Available

  • Pharmasite Research, Inc.

    Baltimore, Maryland 21208
    United States

    Site Not Available

  • Capitol Clinical Research Associates

    Rockville, Maryland 20852
    United States

    Site Not Available

  • St. Charles Psychiatric Associates

    St. Charles, Missouri 63301
    United States

    Site Not Available

  • Creighton University Medical School, Department of Psychiatry

    Omaha, Nebraska 68131
    United States

    Site Not Available

  • CNS Research Institute

    Clementon, New Jersey 08021
    United States

    Site Not Available

  • Pulmonary and Allergy Associates, P. A.

    Summit, New Jersey 07901
    United States

    Site Not Available

  • North Carolina Neuropsychiatry, PA

    Chapel Hill, North Carolina 27514
    United States

    Site Not Available

  • University of Cincinnati College of Medicine, Children's Hospital Medical Center

    Cincinnati, Ohio 45229
    United States

    Site Not Available

  • University Hospitals of Cleveland, Division of Child & Adolescent Psychiatry

    Cleveland, Ohio 44106
    United States

    Site Not Available

  • IPS Research Company

    Oklahoma City, Oklahoma 73103
    United States

    Site Not Available

  • Drexel University College of Medicine, Friends Hospital

    Philadelphia, Pennsylvania 19124
    United States

    Site Not Available

  • University of Pennsylvania, Department of Psychiatry, Mood & Anxiety Disorders Section

    Philadelphia, Pennsylvania 19104
    United States

    Site Not Available

  • Clinical Neuroscience Solutions

    Memphis, Tennessee 38119
    United States

    Site Not Available

  • University of Texas Southwestern Medical Center, Center for Pediatric Psychiatry

    Dallas, Texas 75235
    United States

    Site Not Available

  • University of Texas Medical Branch, Department of Psychiatry & Behavioral Sciences

    Galveston, Texas 77555
    United States

    Site Not Available

  • Brighton Research Group, LLC

    Virginia Beach, Virginia 23452
    United States

    Site Not Available

  • Northwest Clinical Research Center

    Bellevue, Washington 98004
    United States

    Site Not Available

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