Safety Study of Escitalopram in Children 7 to 11 Years of Age With Major Depressive Disorder
Primary Purpose
Major Depressive Disorder
Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Escitalopram
Sponsored by
About this trial
This is an interventional treatment trial for Major Depressive Disorder focused on measuring depression, major depressive disorder, escitalopram, Lexapro, pediatric
Eligibility Criteria
Inclusion Criteria:
- Male or female outpatients 7 to 11 years of age, inclusive
- Current diagnosis of MDD based on DSM-IV-TR (Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision) criteria as confirmed by K-SADS-PL (Kiddie Schedule for Affective Disorders and Schizophrenia-Present and Lifetime) with a minimum duration of 6 weeks
- Patient's parent(s), guardian(s), or LAR(s) is capable of providing information about his or her condition, provides informed consent, and agrees to accompany the patient to all study visits. (Preferably the same parent, guardian, or LAR will accompany the patient to all study visits)
- Patient's family is sufficiently organized and stable to guarantee adequate safety monitoring
Exclusion Criteria:
- Current principal DSM-IV-TR-based diagnosis of an axis I disorder other than MDD that was the primary focus of treatment
- Patients with a diagnosis of conduct disorder will not be allowed to participate in this study
- Current diagnosis of mental retardation, dementia, or amnestic or other cognitive disorders based on DSM-IV-TR criteria
- History of allergy, intolerance, or hypersensitivity to escitalopram, citalopram, or other drugs of the same class
- Imminent risk of injuring self or others or causing significant damage to property, as judged by the PI
Suicide risk as determined by meeting any of the following criteria:
- Any suicide attempt
- Significant risk, as judged by the PI, based on the psychiatric interview or information collected in the Columbia-Suicide Severity Rating Scale (C-SSRS)
Sites / Locations
- Forest Investigative Site 001
- Forest Investigative Site 006
- Forest Investigative Site 018
- Forest Investigative Site 008
- Forest Investigative Site 013
- Forest Investigative Site 017
- Forest Investigative Site 004
- Forest Investigative Site 011
- Forest Investigative Site 007
- Forest Investigative Site 002
- Forest Investigative Site 012
- Forest Investigative Site 003
- Forest Investigative Site 010
- Forest Investigative Site 014
- Forest Investigative Site 005
- Forest Investigative Site 015
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
1
Arm Description
Flexible-dose 10mg-20mg once-daily oral (10mg tablets) dose of escitalopram
Outcomes
Primary Outcome Measures
Patients With Any Treatment Emergent Adverse Events (TEAEs)
The number of patients who experienced one or more TEAE during the 24-week open-label treatment period or the 2-week down-taper period,
Secondary Outcome Measures
Full Information
NCT ID
NCT01198795
First Posted
September 9, 2010
Last Updated
January 31, 2014
Sponsor
Forest Laboratories
1. Study Identification
Unique Protocol Identification Number
NCT01198795
Brief Title
Safety Study of Escitalopram in Children 7 to 11 Years of Age With Major Depressive Disorder
Official Title
An Open-label Long-term Study of Escitalopram in Children 7 to 11 Years of Age With Major Depressive Disorder
Study Type
Interventional
2. Study Status
Record Verification Date
January 2014
Overall Recruitment Status
Completed
Study Start Date
September 2010 (undefined)
Primary Completion Date
January 2013 (Actual)
Study Completion Date
April 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Forest Laboratories
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
This study will evaluate the long-term safety and tolerability of escitalopram (Lexapro) in children 7 to 11 years of age with major depressive disorder (MDD).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Major Depressive Disorder
Keywords
depression, major depressive disorder, escitalopram, Lexapro, pediatric
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
162 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
Flexible-dose 10mg-20mg once-daily oral (10mg tablets) dose of escitalopram
Intervention Type
Drug
Intervention Name(s)
Escitalopram
Other Intervention Name(s)
Lexapro
Intervention Description
Patients who meet eligibility criteria will receive open-label escitalopram. 10-20mg oral administration (10mg tablets) once daily for 24-weeks with a 2-week downtaper period.
Primary Outcome Measure Information:
Title
Patients With Any Treatment Emergent Adverse Events (TEAEs)
Description
The number of patients who experienced one or more TEAE during the 24-week open-label treatment period or the 2-week down-taper period,
Time Frame
From Baseline (Week 0) to Week 26
10. Eligibility
Sex
All
Minimum Age & Unit of Time
7 Years
Maximum Age & Unit of Time
11 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Male or female outpatients 7 to 11 years of age, inclusive
Current diagnosis of MDD based on DSM-IV-TR (Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision) criteria as confirmed by K-SADS-PL (Kiddie Schedule for Affective Disorders and Schizophrenia-Present and Lifetime) with a minimum duration of 6 weeks
Patient's parent(s), guardian(s), or LAR(s) is capable of providing information about his or her condition, provides informed consent, and agrees to accompany the patient to all study visits. (Preferably the same parent, guardian, or LAR will accompany the patient to all study visits)
Patient's family is sufficiently organized and stable to guarantee adequate safety monitoring
Exclusion Criteria:
Current principal DSM-IV-TR-based diagnosis of an axis I disorder other than MDD that was the primary focus of treatment
Patients with a diagnosis of conduct disorder will not be allowed to participate in this study
Current diagnosis of mental retardation, dementia, or amnestic or other cognitive disorders based on DSM-IV-TR criteria
History of allergy, intolerance, or hypersensitivity to escitalopram, citalopram, or other drugs of the same class
Imminent risk of injuring self or others or causing significant damage to property, as judged by the PI
Suicide risk as determined by meeting any of the following criteria:
Any suicide attempt
Significant risk, as judged by the PI, based on the psychiatric interview or information collected in the Columbia-Suicide Severity Rating Scale (C-SSRS)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Suneeta Ahuja, PhD
Organizational Affiliation
Forest Laboratories
Official's Role
Study Chair
Facility Information:
Facility Name
Forest Investigative Site 001
City
Dothan
State/Province
Alabama
ZIP/Postal Code
36303
Country
United States
Facility Name
Forest Investigative Site 006
City
San Diego
State/Province
California
ZIP/Postal Code
92108
Country
United States
Facility Name
Forest Investigative Site 018
City
Santa Ana
State/Province
California
ZIP/Postal Code
92701
Country
United States
Facility Name
Forest Investigative Site 008
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20010-2970
Country
United States
Facility Name
Forest Investigative Site 013
City
Jacksonville Beach
State/Province
Florida
ZIP/Postal Code
32250
Country
United States
Facility Name
Forest Investigative Site 017
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30308
Country
United States
Facility Name
Forest Investigative Site 004
City
Overland Park
State/Province
Kansas
ZIP/Postal Code
66211
Country
United States
Facility Name
Forest Investigative Site 011
City
Creve Coeur
State/Province
Missouri
ZIP/Postal Code
63141
Country
United States
Facility Name
Forest Investigative Site 007
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68131
Country
United States
Facility Name
Forest Investigative Site 002
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106
Country
United States
Facility Name
Forest Investigative Site 012
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73116
Country
United States
Facility Name
Forest Investigative Site 003
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19139
Country
United States
Facility Name
Forest Investigative Site 010
City
Dallas
State/Province
Texas
ZIP/Postal Code
75235
Country
United States
Facility Name
Forest Investigative Site 014
City
Clinton
State/Province
Utah
ZIP/Postal Code
84015
Country
United States
Facility Name
Forest Investigative Site 005
City
Bellevue
State/Province
Washington
ZIP/Postal Code
98007
Country
United States
Facility Name
Forest Investigative Site 015
City
Kirkland
State/Province
Washington
ZIP/Postal Code
98033
Country
United States
12. IPD Sharing Statement
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Safety Study of Escitalopram in Children 7 to 11 Years of Age With Major Depressive Disorder
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