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

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. Identifier: NCT00107120
Recruitment Status : Completed
First Posted : April 6, 2005
Results First Posted : November 4, 2009
Last Update Posted : April 6, 2012
Information provided by (Responsible Party):
Forest Laboratories

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

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
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

  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

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