Text Size

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
History of Changes
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
  Show Participant Flow


  Baseline Characteristics
  Hide Baseline Characteristics

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 ]
  Show Outcome Measure 1

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

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


  Serious Adverse Events
  Show Serious Adverse Events


  Other Adverse Events
  Show Other Adverse Events


  More Information
  Hide More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


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.  


Results Point of Contact:  
Name/Title: Daniel Ventura, PhD
Organization: Forest Research Institute, a subsidiary of Forest Laboratories, Inc.
phone: 201-427-8252
e-mail: daniel.ventura@frx.com


Publications of Results:


Responsible Party: Forest Laboratories
ClinicalTrials.gov Identifier: NCT00107120     History of Changes
Other Study ID Numbers: SCT-MD-32
Study First Received: April 5, 2005
Results First Received: April 21, 2009
Last Updated: April 4, 2012
Health Authority: United States: Food and Drug Administration