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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
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
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Recruitment period was from April 1, 2005 through March, 2007 at 40 centers in the US.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
2 week screening with one-week single-blind placebo. Patients meeting selection criteria at baseline were randomized to once daily escitalopram 10-20mg/day or placebo (1:1).

Reporting Groups
  Description
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

Participant Flow:   Overall Study
    Escitalopram   Placebo
STARTED   155 [1]   157 [1] 
COMPLETED   126   133 
NOT COMPLETED   29   24 
Adverse Event                4                1 
Lack of Efficacy                5                5 
Protocol Violation                3                0 
Withdrawal by Subject                8                9 
Lost to Follow-up                8                6 
Pregnancy                0                1 
moving away from site                1                1 
death of parent                0                1 
[1] Safety Population defined as all patients who took at least one dose of double-blind study drug



  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.
No text entered.

Reporting Groups
  Description
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 Analyzed 
[Units: Participants]
 155   157   312 
Age 
[Units: Participants]
     
<=18 years   155   157   312 
Between 18 and 65 years   0   0   0 
>=65 years   0   0   0 
Age 
[Units: Years]
Mean (Standard Deviation)
 14.7  (1.6)   14.5  (1.5)   14.6  (1.6) 
Gender 
[Units: Participants]
     
Female   92   92   184 
Male   63   65   128 
Region of Enrollment 
[Units: Participants]
     
United States   155   157   312 


  Outcome Measures
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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
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Time Frame No text entered.
Additional Description No text entered.

Reporting Groups
  Description
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

Serious Adverse Events
    Escitalopram   Placebo
Total, serious adverse events     
# participants affected / at risk   4/155 (2.58%)   2/157 (1.27%) 
General disorders     
Inflicted Injury * 1     
# participants affected / at risk   2/155 (1.29%)   0/157 (0.00%) 
Psychiatric disorders     
Irritability * 1     
# participants affected / at risk   1/155 (0.65%)   0/157 (0.00%) 
Suicidal Tendency * 1     
# participants affected / at risk   1/155 (0.65%)   1/157 (0.64%) 
Depression Aggravated * 1     
# participants affected / at risk   0/155 (0.00%)   1/157 (0.64%) 
* Events were collected by non-systematic assessment
1 Term from vocabulary, WHOART v.1998/04




  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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  More Information