Clinical trial NCT00107120: The Safety and Efficacy of Escitalopram in Pediatric Patients With Major Depressive Disorder
Official title: A Double-blind Flexible Dose Study of Escitalopram in Pediatric Patients With Major Depressive Disorder
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Major Depressive Disorder
Keywords: Major Depressive Disorder
Depression
Adolescents
Escitalopram
Pediatrics
Lead sponsor: Forest Laboratories
Sponsor class: INDUSTRY
First posted: 2005-04-06
Enrollment: 312
Sex: ALL
Minimum age (years): 12
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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.

Primary outcomes:
measure: Change in Children's Depression Rating Scale - Revised (CDRS-R) Total Score
timeFrame: Baseline to end of week 8
Secondary outcomes:
measure: Clinical Global Impressions - Improvement
timeFrame: CGI-I score at the end of Week 8
Other outcomes:
measure: Children's Global Assessment Scale
timeFrame: At baseline and end of week 8
Locations:
city: Sacramento
country: United States
facility: University of California at Davis, MIND Institute, Health Services
state: California
city: San Diego
country: United States
facility: UCSD Outpatient Psychiatry Services
state: California
city: San Diego
country: United States
facility: PCSD - Feighner Research
state: California
city: Washington
country: United States
facility: Children's National Medical Center
state: District of Columbia
city: Gainesville
country: United States
facility: University of Florida - Child Study Program
state: Florida
city: Jacksonville
country: United States
facility: Clinical Neuroscience Solutions, Inc.
state: Florida
city: West Palm Beach
country: United States
facility: Janus Center for Psychiatric Research
state: Florida
city: Winter Park
country: United States
facility: Kolin Research Group
state: Florida
city: Libertyville
country: United States
facility: Capstone Clinical Research
state: Illinois
city: Terre Haute
country: United States
facility: Clinco
state: Indiana
city: Overland
country: United States
facility: Psychiatric Associates
state: Kansas
city: Baltimore
country: United States
facility: Pharmasite Research, Inc.
state: Maryland
city: Rockville
country: United States
facility: Capitol Clinical Research Associates
state: Maryland
city: St. Charles
country: United States
facility: St. Charles Psychiatric Associates
state: Missouri
city: Omaha
country: United States
facility: Creighton University Medical School, Department of Psychiatry
state: Nebraska
city: Clementon
country: United States
facility: CNS Research Institute
state: New Jersey
city: Summit
country: United States
facility: Pulmonary and Allergy Associates, P. A.
state: New Jersey
city: Chapel Hill
country: United States
facility: North Carolina Neuropsychiatry, PA
state: North Carolina
city: Cincinnati
country: United States
facility: University of Cincinnati College of Medicine, Children's Hospital Medical Center
state: Ohio
city: Cleveland
country: United States
facility: University Hospitals of Cleveland, Division of Child & Adolescent Psychiatry
state: Ohio
city: Oklahoma City
country: United States
facility: IPS Research Company
state: Oklahoma
city: Philadelphia
country: United States
facility: University of Pennsylvania, Department of Psychiatry, Mood & Anxiety Disorders Section
state: Pennsylvania
city: Philadelphia
country: United States
facility: Drexel University College of Medicine, Friends Hospital
state: Pennsylvania
city: Memphis
country: United States
facility: Clinical Neuroscience Solutions
state: Tennessee
city: Dallas
country: United States
facility: University of Texas Southwestern Medical Center, Center for Pediatric Psychiatry
state: Texas
city: Galveston
country: United States
facility: University of Texas Medical Branch, Department of Psychiatry & Behavioral Sciences
state: Texas
city: Virginia Beach
country: United States
facility: Brighton Research Group, LLC
state: Virginia
city: Bellevue
country: United States
facility: Northwest Clinical Research Center
state: Washington
Study officials:
affiliation: Forest Research Institute, a subsidiary of Forest Laboratories, Inc.
name: Daniel Ventura, PhD
role: STUDY_DIRECTOR
References:
citation: 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.