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

This study has been completed.
Information provided by (Responsible Party):
Forest Laboratories Identifier:
First received: April 5, 2005
Last updated: April 4, 2012
Last verified: April 2012
Results First Received: April 21, 2009  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Major Depressive Disorder
Interventions: Drug: Escitalopram
Drug: Placebo

  Participant Flow

  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups
Escitalopram Once daily oral administration of escitalopram tablets - 1 tablet (10mg) for the first three weeks, then 1 tablet (10mg or 20mg) depending on therapeutic response and tolerability.
Placebo Once daily oral administration of placebo tablets
Total Total of all reporting groups

Baseline Measures
    Escitalopram   Placebo   Total
Overall Participants 
[units: participants]
 155   157   312 
[units: participants]
<=18 years   155   157   312 
Between 18 and 65 years   0   0   0 
>=65 years   0   0   0 
[units: years]
Mean (Standard Deviation)
 14.7  (1.6)   14.5  (1.5)   14.6  (1.6) 
[units: participants]
Female   92   92   184 
Male   63   65   128 
Region of Enrollment 
[units: participants]
United States   155   157   312 

  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Change in Children's Depression Rating Scale - Revised (CDRS-R) Total Score   [ Time Frame: Baseline to end of week 8 ]

2.  Secondary:   Clinical Global Impressions - Improvement   [ Time Frame: CGI-I score at the end of Week 8 ]

3.  Other Pre-specified:   Children's Global Assessment Scale   [ Time Frame: At baseline and end of week 8 ]

  Serious Adverse Events

  Other Adverse Events

  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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