The Safety and Efficacy of Escitalopram in Pediatric Patients With Major Depressive Disorder
A Double-blind Flexible Dose Study of Escitalopram in Pediatric Patients With Major Depressive Disorder
1 other identifier
interventional
312
1 country
28
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3 major-depressive-disorder
28 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2005
CompletedFirst Submitted
Initial submission to the registry
April 5, 2005
CompletedFirst Posted
Study publicly available on registry
April 6, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2007
CompletedResults Posted
Study results publicly available
November 4, 2009
CompletedApril 6, 2012
April 1, 2012
2.2 years
April 5, 2005
April 21, 2009
April 4, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in Children's Depression Rating Scale - Revised (CDRS-R) Total Score
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.
Baseline to end of week 8
Secondary Outcomes (1)
Clinical Global Impressions - Improvement
CGI-I score at the end of Week 8
Other Outcomes (1)
Children's Global Assessment Scale
At baseline and end of week 8
Study Arms (2)
Escitalopram
EXPERIMENTALEscitalopram 10mg once daily for three weeks, 10-20mg once daily for up to the remaining 5 weeks
2
PLACEBO COMPARATORPlacebo once daily for up to 8 weeks
Interventions
Escitalopram 10mg per day for three weeks, 10-20mg per day for up to the remaining 5 weeks
Eligibility Criteria
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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (28)
University of California at Davis, MIND Institute, Health Services
Sacramento, California, 95817, United States
UCSD Outpatient Psychiatry Services
San Diego, California, 92103, United States
PCSD - Feighner Research
San Diego, California, 92111, United States
Children's National Medical Center
Washington D.C., 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
Saint 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
University of Pennsylvania, Department of Psychiatry, Mood & Anxiety Disorders Section
Philadelphia, Pennsylvania, 19104, United States
Drexel University College of Medicine, Friends Hospital
Philadelphia, Pennsylvania, 19124, 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
Related Publications (1)
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.
PMID: 19465881RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Daniel Ventura, PhD
- Organization
- Forest Research Institute, a subsidiary of Forest Laboratories, Inc.
Study Officials
- STUDY DIRECTOR
Daniel Ventura, PhD
Forest Research Institute, a subsidiary of Forest Laboratories, Inc.
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 5, 2005
First Posted
April 6, 2005
Study Start
March 1, 2005
Primary Completion
May 1, 2007
Last Updated
April 6, 2012
Results First Posted
November 4, 2009
Record last verified: 2012-04