- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01198795
Safety Study of Escitalopram in Children 7 to 11 Years of Age With Major Depressive Disorder
January 31, 2014 updated by: Forest Laboratories
An Open-label Long-term Study of Escitalopram in Children 7 to 11 Years of Age With Major Depressive Disorder
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).
Study Overview
Study Type
Interventional
Enrollment (Actual)
162
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Alabama
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Dothan, Alabama, United States, 36303
- Forest Investigative Site 001
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California
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San Diego, California, United States, 92108
- Forest Investigative Site 006
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Santa Ana, California, United States, 92701
- Forest Investigative Site 018
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District of Columbia
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Washington, District of Columbia, United States, 20010-2970
- Forest Investigative Site 008
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Florida
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Jacksonville Beach, Florida, United States, 32250
- Forest Investigative Site 013
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Georgia
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Atlanta, Georgia, United States, 30308
- Forest Investigative Site 017
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Kansas
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Overland Park, Kansas, United States, 66211
- Forest Investigative Site 004
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Missouri
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Creve Coeur, Missouri, United States, 63141
- Forest Investigative Site 011
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Nebraska
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Omaha, Nebraska, United States, 68131
- Forest Investigative Site 007
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Ohio
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Cleveland, Ohio, United States, 44106
- Forest Investigative Site 002
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Oklahoma
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Oklahoma City, Oklahoma, United States, 73116
- Forest Investigative Site 012
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Pennsylvania
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Philadelphia, Pennsylvania, United States, 19139
- Forest Investigative Site 003
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Texas
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Dallas, Texas, United States, 75235
- Forest Investigative Site 010
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Utah
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Clinton, Utah, United States, 84015
- Forest Investigative Site 014
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Washington
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Bellevue, Washington, United States, 98007
- Forest Investigative Site 005
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Kirkland, Washington, United States, 98033
- Forest Investigative Site 015
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
7 years to 11 years (Child)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: 1
Flexible-dose 10mg-20mg once-daily oral (10mg tablets) dose of escitalopram
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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.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Patients With Any Treatment Emergent Adverse Events (TEAEs)
Time Frame: From Baseline (Week 0) to Week 26
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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,
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From Baseline (Week 0) to Week 26
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Chair: Suneeta Ahuja, PhD, Forest Laboratories
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2010
Primary Completion (Actual)
January 1, 2013
Study Completion (Actual)
April 1, 2013
Study Registration Dates
First Submitted
September 9, 2010
First Submitted That Met QC Criteria
September 9, 2010
First Posted (Estimate)
September 10, 2010
Study Record Updates
Last Update Posted (Estimate)
March 14, 2014
Last Update Submitted That Met QC Criteria
January 31, 2014
Last Verified
January 1, 2014
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Behavioral Symptoms
- Mental Disorders
- Pathologic Processes
- Mood Disorders
- Depression
- Depressive Disorder
- Disease
- Depressive Disorder, Major
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Psychotropic Drugs
- Serotonin Uptake Inhibitors
- Neurotransmitter Uptake Inhibitors
- Membrane Transport Modulators
- Serotonin Agents
- Antidepressive Agents
- Antidepressive Agents, Second-Generation
- Citalopram
Other Study ID Numbers
- SCT-MD-55
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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