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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Forest Laboratories
ClinicalTrials.gov Identifier:
NCT00107120
First received: April 5, 2005
Last updated: April 4, 2012
Last verified: April 2012
  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 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Double-blind Flexible Dose Study of Escitalopram in Pediatric Patients With Major Depressive Disorder

Resource links provided by NLM:


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 ]
    Change from baseline to week 8 in Children's Depression Rating Scale total score. The scale measures 17 depressive symptoms, of which 3 are rated 1-5 and 14 are rated 1-7 (1 = no symptom difficulties; 5 or 7 = severe clinically significant difficulties) for a total score range of 17-113.


Secondary Outcome Measures:
  • Clinical Global Impressions - Improvement [ Time Frame: CGI-I score at the end of Week 8 ] [ Designated as safety issue: No ]
    Clinical Global Impressions - Improvement score at the end of week 8. The scale rates improvement or worsening of patient mental health relative to baseline on a scale from 1 (very much improved) to 7 (very much worse).


Enrollment: 312
Study Start Date: March 2005
Primary Completion Date: May 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Escitalopram
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
Other Name: Lexapro (TM)
Placebo Comparator: 2
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

  Hide Study Locations
Locations
United States, California
University of California at Davis, MIND Institute, Health Services
Sacramento, California, United States, 95817
UCSD Outpatient Psychiatry Services
San Diego, California, United States, 92103
PCSD - Feighner Research
San Diego, California, United States, 92111
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
Clinical Neuroscience Solutions, Inc.
Jacksonville, Florida, United States, 32216
Janus Center for Psychiatric Research
West Palm Beach, Florida, United States, 33407
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
Pharmasite Research, Inc.
Baltimore, Maryland, United States, 21208
Capitol Clinical Research Associates
Rockville, Maryland, United States, 20852
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 of Cincinnati College of Medicine, Children's Hospital Medical Center
Cincinnati, Ohio, United States, 45229
University Hospitals of Cleveland, Division of Child & Adolescent Psychiatry
Cleveland, Ohio, United States, 44106
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 Southwestern Medical Center, Center for Pediatric Psychiatry
Dallas, Texas, United States, 75235
University of Texas Medical Branch, Department of Psychiatry & Behavioral Sciences
Galveston, Texas, United States, 77555
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

Publications:
Responsible Party: Forest Laboratories
ClinicalTrials.gov Identifier: NCT00107120     History of Changes
Other Study ID Numbers: SCT-MD-32
Study First Received: April 5, 2005
Results First Received: April 21, 2009
Last Updated: April 4, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Forest Laboratories:
Major Depressive Disorder
Depression
Adolescents
Escitalopram
Pediatrics

Additional relevant MeSH terms:
Depression
Depressive Disorder
Depressive Disorder, Major
Disease
Behavioral Symptoms
Mental Disorders
Mood Disorders
Pathologic Processes
Citalopram
Dexetimide
Anti-Dyskinesia Agents
Antidepressive Agents
Antidepressive Agents, Second-Generation
Antiparkinson Agents
Autonomic Agents
Central Nervous System Agents
Cholinergic Agents
Cholinergic Antagonists
Molecular Mechanisms of Pharmacological Action
Muscarinic Antagonists
Neurotransmitter Agents
Neurotransmitter Uptake Inhibitors
Parasympatholytics
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Psychotropic Drugs
Serotonin Agents
Serotonin Uptake Inhibitors
Therapeutic Uses

ClinicalTrials.gov processed this record on October 20, 2014