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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00107120
First Posted: April 6, 2005
Last Update Posted: April 6, 2012
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.
Information provided by (Responsible Party):
Forest Laboratories
Results First Submitted: April 21, 2009  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, 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 ]
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Measure Type Primary
Measure Title Change in Children's Depression Rating Scale - Revised (CDRS-R) Total Score
Measure Description 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.
Time Frame Baseline to end of week 8  

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.
Efficacy analyses used Intent-To-Treat Population, which consisted of all patients who received at least 1 dose of double-blind study drug & who had at least 1 post-baseline assessment of the CDRS-R. LOCF technique was used to impute missing data. 1 escitalopram pt. did not have a post-baseline CDRS-R total score.

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

Measured Values
   Escitalopram   Placebo 
Participants Analyzed 
[Units: Participants]
 154   157 
Change in Children's Depression Rating Scale - Revised (CDRS-R) Total Score 
[Units: Change in total score at endpoint]
Mean (Standard Error)
 -22.4  (1.1)   -18.4  (1.1) 


Statistical Analysis 1 for Change in Children's Depression Rating Scale - Revised (CDRS-R) Total Score
Groups [1] All groups
Statistical Test Type [2] Superiority or Other
Statistical Method [3] ANCOVA
P Value [4] 0.022
Least Square Means Difference [5] -3.4
95% Confidence Interval -6.2 to -0.5
Standard Error of the mean (1.458)
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  The null hypothesis is that there is no difference in the Change from Baseline to Week 8 in CDRS-R total score between treatment groups. The power calculation was based on the change from baseline to Week 8 in CDRS-R total score (LOCF approach). Assuming an effect size (treatment group difference relative to standard deviation) of 0.325, a sample size of approximately 150 patients per treatment group was used to provide at least 80% power at a significance level of 0.05 using a two-sided test.
[2] Details of power calculation, definition of non-inferiority margin, and other key parameters:
  No text entered.
[3] Other relevant method information, such as adjustments or degrees of freedom:
  The model included study center and treatment as factors and baseline core as covariate
[4] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  Two-sided at 5% level of significance p < 0.05 considered significant
[5] Other relevant estimation information:
  Differences are Escitalopram-Placebo



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
No text entered.


  More Information