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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Forest Laboratories
ClinicalTrials.gov Identifier:
NCT01198795
First received: September 9, 2010
Last updated: January 31, 2014
Last verified: January 2014

September 9, 2010
January 31, 2014
September 2010
January 2013   (final data collection date for primary outcome measure)
Patients With Any Treatment Emergent Adverse Events (TEAEs) [ Time Frame: From Baseline (Week 0) to Week 26 ] [ Designated as safety issue: Yes ]
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,
Safety Measures [ Time Frame: 26 weeks ] [ Designated as safety issue: Yes ]
Adverse event recording Clinical laboratory measures Vital sign parameters Electrocardiographic parameters Physical examination findings Columbia-Suicide Severity Rating Scale (C-SSRS) assessments
Complete list of historical versions of study NCT01198795 on ClinicalTrials.gov Archive Site
Not Provided
Efficacy Measures [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
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)
Not Provided
Not Provided
 
Safety Study of Escitalopram in Children 7 to 11 Years of Age With Major Depressive Disorder
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).

Not Provided
Interventional
Phase 4
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Major Depressive Disorder
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
Experimental: 1
Flexible-dose 10mg-20mg once-daily oral (10mg tablets) dose of escitalopram
Intervention: Drug: Escitalopram
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
162
April 2013
January 2013   (final data collection date for primary outcome measure)

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)
Both
7 Years to 11 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01198795
SCT-MD-55
No
Forest Laboratories
Forest Laboratories
Not Provided
Study Chair: Suneeta Ahuja, PhD Forest Laboratories
Forest Laboratories
January 2014

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