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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Forest Laboratories
ClinicalTrials.gov Identifier:
NCT00107120
First received: April 5, 2005
Last updated: April 4, 2012
Last verified: April 2012

April 5, 2005
April 4, 2012
March 2005
May 2007   (final data collection date for primary outcome measure)
Change in Children's Depression Rating Scale - Revised (CDRS-R) Total Score [ Time Frame: Baseline to end of week 8 ] [ Designated as safety issue: No ]
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.
Children's Depression Rating Scale - Revised
Complete list of historical versions of study NCT00107120 on ClinicalTrials.gov Archive Site
Clinical Global Impressions - Improvement [ Time Frame: CGI-I score at the end of Week 8 ] [ Designated as safety issue: No ]
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).
  • Clinical Global Impression Scales (Severity and Improvement)
  • Children's Global assessment Scale
Not Provided
Not Provided
 
The Safety and Efficacy of Escitalopram in Pediatric Patients With Major Depressive Disorder
A Double-blind Flexible Dose Study of Escitalopram in Pediatric Patients With Major Depressive Disorder

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.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Major Depressive Disorder
  • Drug: Escitalopram
    Escitalopram 10mg per day for three weeks, 10-20mg per day for up to the remaining 5 weeks
    Other Name: Lexapro (TM)
  • Drug: Placebo
    Placebo once daily for up to 8 weeks
  • Experimental: Escitalopram
    Escitalopram 10mg once daily for three weeks, 10-20mg once daily for up to the remaining 5 weeks
    Intervention: Drug: Escitalopram
  • Placebo Comparator: 2
    Placebo once daily for up to 8 weeks
    Intervention: Drug: Placebo
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):721-9.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
312
Not Provided
May 2007   (final data collection date for primary outcome measure)

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:

    1. attention deficit-hyperactivity disorder
    2. obsessive-compulsive disorder
    3. posttraumatic stress disorder
    4. bipolar disorder
    5. pervasive developmental disorder
    6. mental retardation
    7. conduct disorder
    8. 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.
Both
12 Years to 17 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00107120
SCT-MD-32
Not Provided
Forest Laboratories
Forest Laboratories
Not Provided
Study Director: Daniel Ventura, PhD Forest Research Institute, a subsidiary of Forest Laboratories, Inc.
Forest Laboratories
April 2012

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