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The Safety and Efficacy of Escitalopram in Pediatric Patients 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: NCT00107120
Recruitment Status : Completed
First Posted : April 6, 2005
Results First Posted : November 4, 2009
Last Update Posted : April 6, 2012
Sponsor:
Information provided by (Responsible Party):
Forest Laboratories

Tracking Information
First Submitted Date  ICMJE April 5, 2005
First Posted Date  ICMJE April 6, 2005
Results First Submitted Date  ICMJE April 21, 2009
Results First Posted Date  ICMJE November 4, 2009
Last Update Posted Date April 6, 2012
Study Start Date  ICMJE March 2005
Actual Primary Completion Date May 2007   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 25, 2009)
Change in Children's Depression Rating Scale - Revised (CDRS-R) Total Score [ Time Frame: Baseline to end of week 8 ]
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.
Original Primary Outcome Measures  ICMJE
 (submitted: June 23, 2005)
Children's Depression Rating Scale - Revised
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 3, 2009)
Clinical Global Impressions - Improvement [ Time Frame: CGI-I score at the end of Week 8 ]
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).
Original Secondary Outcome Measures  ICMJE
 (submitted: June 23, 2005)
  • Clinical Global Impression Scales (Severity and Improvement)
  • Children's Global assessment Scale
Current Other Pre-specified Outcome Measures
 (submitted: September 25, 2009)
Children's Global Assessment Scale [ Time Frame: At baseline and end of week 8 ]
Change from baseline to week 8 in CGAS score which rates the patient's general level of functioning for the past 14 days on a scale of 1 (most impaired) to 100 (healthiest).
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The Safety and Efficacy of Escitalopram in Pediatric Patients With Major Depressive Disorder
Official Title  ICMJE A Double-blind Flexible Dose Study of Escitalopram in Pediatric Patients With Major Depressive Disorder
Brief Summary 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Major Depressive Disorder
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • 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
Publications * 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):721-729. doi: 10.1097/CHI.0b013e3181a2b304.

*   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: September 25, 2009)
312
Original Enrollment  ICMJE
 (submitted: June 23, 2005)
300
Study Completion Date  ICMJE Not Provided
Actual Primary Completion Date May 2007   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 12 Years to 17 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 NCT00107120
Other Study ID Numbers  ICMJE SCT-MD-32
Has Data Monitoring Committee Not Provided
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 Director: Daniel Ventura, PhD Forest Research Institute, a subsidiary of Forest Laboratories, Inc.
PRS Account Forest Laboratories
Verification Date April 2012

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