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

Condition(s) targeted: Major Depressive Disorder

Intervention: Escitalopram (Drug); Placebo (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Forest Laboratories

Official(s) and/or principal investigator(s):
Daniel Ventura, PhD, Study Director, Affiliation: Forest Research Institute, a subsidiary of Forest Laboratories, Inc.

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.

Official title: A Double-blind Flexible Dose Study of Escitalopram in Pediatric Patients With Major Depressive Disorder

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: Change in Children's Depression Rating Scale - Revised (CDRS-R) Total Score

Secondary outcome: Clinical Global Impressions - Improvement

Minimum age: 12 Years. Maximum age: 17 Years. Gender(s): Both.

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.

University of California at Davis, MIND Institute, Health Services, Sacramento, California 95817, United States

PCSD - Feighner Research, San Diego, California 92111, United States

UCSD Outpatient Psychiatry Services, San Diego, California 92103, United States

Children's National Medical Center, Washington, District of Columbia 20010, United States

University of Florida - Child Study Program, Gainesville, Florida 32610, United States

Clinical Neuroscience Solutions, Inc., Jacksonville, Florida 32216, United States

Janus Center for Psychiatric Research, West Palm Beach, Florida 33407, United States

Kolin Research Group, Winter Park, Florida 32789, United States

Capstone Clinical Research, Libertyville, Illinois 60048, United States

Clinco, Terre Haute, Indiana 47802, United States

Psychiatric Associates, Overland, Kansas 66211, United States

Pharmasite Research, Inc., Baltimore, Maryland 21208, United States

Capitol Clinical Research Associates, Rockville, Maryland 20852, United States

St. Charles Psychiatric Associates, St. Charles, Missouri 63301, United States

Creighton University Medical School, Department of Psychiatry, Omaha, Nebraska 68131, United States

CNS Research Institute, Clementon, New Jersey 08021, United States

Pulmonary and Allergy Associates, P. A., Summit, New Jersey 07901, United States

North Carolina Neuropsychiatry, PA, Chapel Hill, North Carolina 27514, United States

University of Cincinnati College of Medicine, Children's Hospital Medical Center, Cincinnati, Ohio 45229, United States

University Hospitals of Cleveland, Division of Child & Adolescent Psychiatry, Cleveland, Ohio 44106, United States

IPS Research Company, Oklahoma City, Oklahoma 73103, United States

Drexel University College of Medicine, Friends Hospital, Philadelphia, Pennsylvania 19124, United States

University of Pennsylvania, Department of Psychiatry, Mood & Anxiety Disorders Section, Philadelphia, Pennsylvania 19104, United States

Clinical Neuroscience Solutions, Memphis, Tennessee 38119, United States

University of Texas Southwestern Medical Center, Center for Pediatric Psychiatry, Dallas, Texas 75235, United States

University of Texas Medical Branch, Department of Psychiatry & Behavioral Sciences, Galveston, Texas 77555, United States

Brighton Research Group, LLC, Virginia Beach, Virginia 23452, United States

Northwest Clinical Research Center, Bellevue, Washington 98004, United States

Starting date: March 2005
Last updated: April 4, 2012