Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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
  Hide Participant Flow

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
  Hide Baseline Characteristics

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  
Number of Participants  
[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
  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
  Hide Serious Adverse Events

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
  Hide Limitations and Caveats

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