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

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

	Escitalopram	Placebo
STARTED	155^[1]	157^[2]
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
[2]	Safety Population defined as all patients who took at least one dose of double-blind study drug

Baseline Characteristics

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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

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1. Primary:

Change in Children's Depression Rating Scale - Revised (CDRS-R) Total Score [ 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
Safety Issue	No

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
Number of 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
Method ^[2]	ANCOVA
P Value ^[3]	0.022
Least Square Means Difference ^[4]	-3.4
Standard Error of the mean	± 1.458
95% Confidence Interval	( -6.2 to -0.5 )

[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]	Other relevant information, such as adjustments or degrees of freedom:
	The model included study center and treatment as factors and baseline core as covariate
[3]	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
[4]	Other relevant estimation information:
	Differences are Escitalopram-Placebo

2. Secondary:

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

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3. Other Pre-specified:

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

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Serious Adverse Events

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Other Adverse Events

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More Information

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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:

	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.
	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.
	Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed. Restriction Description: Sponsor can review results communications prior to public release & can embargo communications re: results for 90 days from time submitted to sponsor for review. PI shall not disclose sponsor’s confidential info. Upon sponsor’s request, PI shall delete any proprietary info & shall not include raw data in pub. On sponsor’s request, PI shall delay submission for any pub while sponsor files patent apps. If trial is multi-center, PI agrees that first publication shall be a multi-center pub.

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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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

No publications provided by Forest Laboratories

Publications automatically indexed to this study:

Emslie GJ, Ventura D, Korotzer A, Tourkodimitris S. Escitalopram in the treatment of adolescent depression: a randomized placebo-controlled multisite trial. J Am Acad Child Adolesc Psychiatry. 2009 Jul;48(7):721-9.

Responsible Party:	Forest Research Institute, a subsidiary of Forest Laboratories, Inc. ( Anjana Bose, PhD )
Study ID Numbers:	SCT-MD-32
Study First Received:	April 5, 2005
Results First Received:	April 21, 2009
Last Updated:	September 25, 2009
ClinicalTrials.gov Identifier:	NCT00107120 History of Changes
Health Authority:	United States: Food and Drug Administration