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Safety Study of Escitalopram in Children 7 to 11 Years of Age With Major Depressive Disorder

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01198795
Recruitment Status : Completed
First Posted : September 10, 2010
Results First Posted : March 14, 2014
Last Update Posted : March 14, 2014
Sponsor:
Information provided by (Responsible Party):
Forest Laboratories

Tracking Information
First Submitted Date  ICMJE September 9, 2010
First Posted Date  ICMJE September 10, 2010
Results First Submitted Date  ICMJE January 31, 2014
Results First Posted Date  ICMJE March 14, 2014
Last Update Posted Date March 14, 2014
Study Start Date  ICMJE September 2010
Actual Primary Completion Date January 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 31, 2014)
Patients With Any Treatment Emergent Adverse Events (TEAEs) [ Time Frame: From Baseline (Week 0) to Week 26 ]
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,
Original Primary Outcome Measures  ICMJE
 (submitted: September 9, 2010)
Safety Measures [ Time Frame: 26 weeks ]
Adverse event recording Clinical laboratory measures Vital sign parameters Electrocardiographic parameters Physical examination findings Columbia-Suicide Severity Rating Scale (C-SSRS) assessments
Change History Complete list of historical versions of study NCT01198795 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE
 (submitted: September 9, 2010)
Efficacy Measures [ Time Frame: 24 weeks ]
Change from baseline in Children's Depression Rating Scale-Revised (CDRS-R) total score Change from baseline in Clinical Global Impressions-Severity (CGI-S) score Clinical Global Impressions-Improvement (CGI-I)
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Safety Study of Escitalopram in Children 7 to 11 Years of Age With Major Depressive Disorder
Official Title  ICMJE An Open-label Long-term Study of Escitalopram in Children 7 to 11 Years of Age With Major Depressive Disorder
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).
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Major Depressive Disorder
Intervention  ICMJE Drug: Escitalopram
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 Name: Lexapro
Study Arms  ICMJE Experimental: 1
Flexible-dose 10mg-20mg once-daily oral (10mg tablets) dose of escitalopram
Intervention: Drug: Escitalopram
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 31, 2014)
162
Original Estimated Enrollment  ICMJE
 (submitted: September 9, 2010)
120
Actual Study Completion Date  ICMJE April 2013
Actual Primary Completion Date January 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 7 Years to 11 Years   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01198795
Other Study ID Numbers  ICMJE SCT-MD-55
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Forest Laboratories
Study Sponsor  ICMJE Forest Laboratories
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Suneeta Ahuja, PhD Forest Laboratories
PRS Account Forest Laboratories
Verification Date January 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP