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

Primary Purpose

Major Depressive Disorder

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Escitalopram
Placebo
Sponsored by
Forest Laboratories
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Major Depressive Disorder focused on measuring Major Depressive Disorder, Depression, Adolescents, Escitalopram, Pediatrics

Eligibility Criteria

12 Years - 17 Years (Child)All SexesDoes not accept healthy volunteers

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: 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.

Sites / Locations

  • University of California at Davis, MIND Institute, Health Services
  • UCSD Outpatient Psychiatry Services
  • PCSD - Feighner Research
  • Children's National Medical Center
  • University of Florida - Child Study Program
  • Clinical Neuroscience Solutions, Inc.
  • Janus Center for Psychiatric Research
  • Kolin Research Group
  • Capstone Clinical Research
  • Clinco
  • Psychiatric Associates
  • Pharmasite Research, Inc.
  • Capitol Clinical Research Associates
  • St. Charles Psychiatric Associates
  • Creighton University Medical School, Department of Psychiatry
  • CNS Research Institute
  • Pulmonary and Allergy Associates, P. A.
  • North Carolina Neuropsychiatry, PA
  • University of Cincinnati College of Medicine, Children's Hospital Medical Center
  • University Hospitals of Cleveland, Division of Child & Adolescent Psychiatry
  • IPS Research Company
  • University of Pennsylvania, Department of Psychiatry, Mood & Anxiety Disorders Section
  • Drexel University College of Medicine, Friends Hospital
  • Clinical Neuroscience Solutions
  • University of Texas Southwestern Medical Center, Center for Pediatric Psychiatry
  • University of Texas Medical Branch, Department of Psychiatry & Behavioral Sciences
  • Brighton Research Group, LLC
  • Northwest Clinical Research Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Escitalopram

2

Arm Description

Escitalopram 10mg once daily for three weeks, 10-20mg once daily for up to the remaining 5 weeks

Placebo once daily for up to 8 weeks

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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).

Full Information

First Posted
April 5, 2005
Last Updated
April 4, 2012
Sponsor
Forest Laboratories
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1. Study Identification

Unique Protocol Identification Number
NCT00107120
Brief Title
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

2. Study Status

Record Verification Date
April 2012
Overall Recruitment Status
Completed
Study Start Date
March 2005 (undefined)
Primary Completion Date
May 2007 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Forest Laboratories

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Major Depressive Disorder
Keywords
Major Depressive Disorder, Depression, Adolescents, Escitalopram, Pediatrics

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
312 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Escitalopram
Arm Type
Experimental
Arm Description
Escitalopram 10mg once daily for three weeks, 10-20mg once daily for up to the remaining 5 weeks
Arm Title
2
Arm Type
Placebo Comparator
Arm Description
Placebo once daily for up to 8 weeks
Intervention Type
Drug
Intervention Name(s)
Escitalopram
Other Intervention Name(s)
Lexapro (TM)
Intervention Description
Escitalopram 10mg per day for three weeks, 10-20mg per day for up to the remaining 5 weeks
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo once daily for up to 8 weeks
Primary Outcome Measure Information:
Title
Change in Children's Depression Rating Scale - Revised (CDRS-R) Total Score
Description
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.
Time Frame
Baseline to end of week 8
Secondary Outcome Measure Information:
Title
Clinical Global Impressions - Improvement
Description
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).
Time Frame
CGI-I score at the end of Week 8
Other Pre-specified Outcome Measures:
Title
Children's Global Assessment Scale
Description
Change from baseline to week 8 in CGAS score which rates the patient's general level of functioning for the past 14 days on a scale of 1 (most impaired) to 100 (healthiest).
Time Frame
At baseline and end of week 8

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
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: 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Daniel Ventura, PhD
Organizational Affiliation
Forest Research Institute, a subsidiary of Forest Laboratories, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
University of California at Davis, MIND Institute, Health Services
City
Sacramento
State/Province
California
ZIP/Postal Code
95817
Country
United States
Facility Name
UCSD Outpatient Psychiatry Services
City
San Diego
State/Province
California
ZIP/Postal Code
92103
Country
United States
Facility Name
PCSD - Feighner Research
City
San Diego
State/Province
California
ZIP/Postal Code
92111
Country
United States
Facility Name
Children's National Medical Center
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20010
Country
United States
Facility Name
University of Florida - Child Study Program
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32610
Country
United States
Facility Name
Clinical Neuroscience Solutions, Inc.
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32216
Country
United States
Facility Name
Janus Center for Psychiatric Research
City
West Palm Beach
State/Province
Florida
ZIP/Postal Code
33407
Country
United States
Facility Name
Kolin Research Group
City
Winter Park
State/Province
Florida
ZIP/Postal Code
32789
Country
United States
Facility Name
Capstone Clinical Research
City
Libertyville
State/Province
Illinois
ZIP/Postal Code
60048
Country
United States
Facility Name
Clinco
City
Terre Haute
State/Province
Indiana
ZIP/Postal Code
47802
Country
United States
Facility Name
Psychiatric Associates
City
Overland
State/Province
Kansas
ZIP/Postal Code
66211
Country
United States
Facility Name
Pharmasite Research, Inc.
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21208
Country
United States
Facility Name
Capitol Clinical Research Associates
City
Rockville
State/Province
Maryland
ZIP/Postal Code
20852
Country
United States
Facility Name
St. Charles Psychiatric Associates
City
St. Charles
State/Province
Missouri
ZIP/Postal Code
63301
Country
United States
Facility Name
Creighton University Medical School, Department of Psychiatry
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68131
Country
United States
Facility Name
CNS Research Institute
City
Clementon
State/Province
New Jersey
ZIP/Postal Code
08021
Country
United States
Facility Name
Pulmonary and Allergy Associates, P. A.
City
Summit
State/Province
New Jersey
ZIP/Postal Code
07901
Country
United States
Facility Name
North Carolina Neuropsychiatry, PA
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27514
Country
United States
Facility Name
University of Cincinnati College of Medicine, Children's Hospital Medical Center
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45229
Country
United States
Facility Name
University Hospitals of Cleveland, Division of Child & Adolescent Psychiatry
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106
Country
United States
Facility Name
IPS Research Company
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73103
Country
United States
Facility Name
University of Pennsylvania, Department of Psychiatry, Mood & Anxiety Disorders Section
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
Drexel University College of Medicine, Friends Hospital
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19124
Country
United States
Facility Name
Clinical Neuroscience Solutions
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38119
Country
United States
Facility Name
University of Texas Southwestern Medical Center, Center for Pediatric Psychiatry
City
Dallas
State/Province
Texas
ZIP/Postal Code
75235
Country
United States
Facility Name
University of Texas Medical Branch, Department of Psychiatry & Behavioral Sciences
City
Galveston
State/Province
Texas
ZIP/Postal Code
77555
Country
United States
Facility Name
Brighton Research Group, LLC
City
Virginia Beach
State/Province
Virginia
ZIP/Postal Code
23452
Country
United States
Facility Name
Northwest Clinical Research Center
City
Bellevue
State/Province
Washington
ZIP/Postal Code
98004
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
19465881
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.
Results Reference
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The Safety and Efficacy of Escitalopram in Pediatric Patients With Major Depressive Disorder

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