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

This study has been completed.

Study NCT00107120 Information provided by Forest Laboratories

First Received: April 5, 2005 Last Updated: September 25, 2009 History of Changes

Study Type:	Interventional
Study Design:	Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment
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

	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

[1]	Safety Population defined as all patients who took at least one dose of double-blind study drug
[2]	Safety Population defined as all patients who took at least one dose of double-blind study drug

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

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

1. Primary:

Change in Children's Depression Rating Scale - Revised (CDRS-R) Total Score [ Baseline to end of week 8 ]

Show Outcome Measure 1

2. Secondary:

Clinical Global Impressions - Improvement [ At end of weeks 1-8 ]

Show Outcome Measure 2

3. Other Pre-specified:

Children's Global Assessment Scale [ At baseline and end of week 8 ]

Show Outcome Measure 3