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

Major Depressive Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00107120
• Other study ID #: SCT-MD-32
• Status: Completed
• Phase: Phase 3
• First received: April 5, 2005
• Last updated: April 4, 2012
• Start date: March 2005

Study information

• Verified date: April 2012
• Source: Forest Laboratories
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 312
• Est. primary completion date: May 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 12 Years to 17 Years

Eligibility

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.

Study Design

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

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Depressive Disorder, Major
• Major Depressive Disorder

Intervention

Drug:
• Escitalopram
Escitalopram 10mg per day for three weeks, 10-20mg per day for up to the remaining 5 weeks
• Placebo
Placebo once daily for up to 8 weeks

Locations

Country	Name	City	State
United States	Pharmasite Research, Inc.	Baltimore	Maryland
United States	Northwest Clinical Research Center	Bellevue	Washington
United States	North Carolina Neuropsychiatry, PA	Chapel Hill	North Carolina
United States	University of Cincinnati College of Medicine, Children's Hospital Medical Center	Cincinnati	Ohio
United States	CNS Research Institute	Clementon	New Jersey
United States	University Hospitals of Cleveland, Division of Child & Adolescent Psychiatry	Cleveland	Ohio
United States	University of Texas Southwestern Medical Center, Center for Pediatric Psychiatry	Dallas	Texas
United States	University of Florida - Child Study Program	Gainesville	Florida
United States	University of Texas Medical Branch, Department of Psychiatry & Behavioral Sciences	Galveston	Texas
United States	Clinical Neuroscience Solutions, Inc.	Jacksonville	Florida
United States	Capstone Clinical Research	Libertyville	Illinois
United States	Clinical Neuroscience Solutions	Memphis	Tennessee
United States	IPS Research Company	Oklahoma City	Oklahoma
United States	Creighton University Medical School, Department of Psychiatry	Omaha	Nebraska
United States	Psychiatric Associates	Overland	Kansas
United States	Drexel University College of Medicine, Friends Hospital	Philadelphia	Pennsylvania
United States	University of Pennsylvania, Department of Psychiatry, Mood & Anxiety Disorders Section	Philadelphia	Pennsylvania
United States	Capitol Clinical Research Associates	Rockville	Maryland
United States	University of California at Davis, MIND Institute, Health Services	Sacramento	California
United States	PCSD - Feighner Research	San Diego	California
United States	UCSD Outpatient Psychiatry Services	San Diego	California
United States	St. Charles Psychiatric Associates	St. Charles	Missouri
United States	Pulmonary and Allergy Associates, P. A.	Summit	New Jersey
United States	Clinco	Terre Haute	Indiana
United States	Brighton Research Group, LLC	Virginia Beach	Virginia
United States	Children's National Medical Center	Washington	District of Columbia
United States	Janus Center for Psychiatric Research	West Palm Beach	Florida
United States	Kolin Research Group	Winter Park	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Forest Laboratories

Country where clinical trial is conducted

United States, 

References & 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):721-9. doi: 10.1097/CHI.0b013e3181a2b304. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Clinical Global Impressions - Improvement	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).	CGI-I score at the end of Week 8	No