Safety Study of Escitalopram in Children 7 to 11 Years of Age With Major Depressive Disorder

• Sponsor: Forest Laboratories
• Information provided by (Responsible Party): Forest Laboratories

Study Type	Interventional
Study Design	Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment
Condition	Major Depressive Disorder
Intervention	Drug: Escitalopram
Enrollment	162

Participant Flow

Recruitment Details	Patient recruitment occurred at 16 studies sites located in the US from October of 2010 to August of 2012.
Pre-assignment Details	All patients completed a 1-week no-drug screening period before beginning treatment with study drug.

Arm/Group Title	Escitalopram
Arm/Group Description	Flexible-dose 10mg-20mg once-daily oral (10mg tablets) dose of escitalopram for 24-weeks, with a 2-week downtaper period.
Period Title: Overall Study
Started	162
Completed	80
Not Completed	82
Reason Not Completed
Did not meet InclusionExclusion criteria	30
Withdrawal by Subject	17
Lost to Follow-up	15
Adverse Event	9
Lack of Efficacy	5
Protocol Violation	2
Other Reason	4

Baseline Characteristics

Arm/Group Title		Escitalopram
Arm/Group Description		Flexible-dose 10mg-20mg once-daily oral (10mg tablets) dose of escitalopram for 24-weeks, with a 2-week downtaper period.
Overall Number of Baseline Participants		118
Baseline Analysis Population Description		A total of 162 unique patients were enrolled in the study. Of these, 118 patients received at least 1 dose of investigational product to comprise the Safety Population. All 118 patients in the Safety Population also had at least 1 postbaseline efficacy assessment, and comprise the Intent To Treat (ITT) Population.
Age, Continuous; Mean (Standard Deviation); Unit of measure: Years
	Number Analyzed	118 participants
		9.4 (1.2)
Age, Customized; Measure Type: Number; Unit of measure: Participants	Number Analyzed	118 participants
Ages 7 Years to 8 Years		31
Ages 9 Years to 10 Years		62
Age 11 Years		25
Sex: Female, Male; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	118 participants
	Female	53 44.9%
	Male	65 55.1%
Race/Ethnicity, Customized; Measure Type: Number; Unit of measure: Participants	Number Analyzed	118 participants
White		85
Black		26
Asian		1
American Indian or Alaska Native		1
Native Hawaiian or Other Pacific Islander		1
Other		4
Race/Ethnicity, Customized; Measure Type: Number; Unit of measure: Participants	Number Analyzed	118 participants
Hispanic or Latino		16
Not Hispanic or Latino		102
Region of Enrollment; Measure Type: Number; Unit of measure: Participants
United States	Number Analyzed	118 participants
		118
Weight, mean; Mean (Standard Deviation); Unit of measure: Kg
	Number Analyzed	118 participants
		42.71 (16.67)
Height, mean; Mean (Standard Deviation); Unit of measure: Cm
	Number Analyzed	118 participants
		141.27 (10.22)
BMI(Body Mass Index), mean; Mean (Standard Deviation); Unit of measure: Kg/m2
	Number Analyzed	118 participants
		20.86 (5.83)

Outcome Measures

1. Primary Outcome

Title	Patients With Any Treatment Emergent Adverse Events (TEAEs)
Description	The number of patients who experienced one or more TEAE during the 24-week open-label treatment period or the 2-week down-taper period,
Time Frame	From Baseline (Week 0) to Week 26

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Escitalopram
Arm/Group Description:	Flexible-dose 10mg-20mg once-daily oral (10mg tablets) dose of escitalopram for 24-weeks, with a 2-week downtaper period.
Overall Number of Participants Analyzed	118
Measure Type: Number; Unit of Measure: participants
	89

Adverse Events

Time Frame	Adverse event data was collected during a 28 month period from October 2010 to February 2013.
Adverse Event Reporting Description	[Not Specified]
Arm/Group Title	Escitalopram
Arm/Group Description	Flexible-dose 10mg-20mg once-daily oral (10mg tablets) dose of escitalopram for 24-weeks, with a 2-week downtaper period.
All-Cause Mortality
	Escitalopram
	Affected / at Risk (%)
Total	--/--
Serious Adverse Events
	Escitalopram
	Affected / at Risk (%)
Total	2/118 (1.69%)
Psychiatric disorders
Mania † 1	1/118 (0.85%)
Suicidal Ideation † 1	1/118 (0.85%)
† Indicates events were collected by systematic assessment; 1 Term from vocabulary, MedDRA (15.1)
Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events	5%
	Escitalopram
	Affected / at Risk (%)
Total	59/118 (50.00%)
Gastrointestinal disorders
Abdominal pain upper † 1	13/118 (11.02%)
Diarrhea † 1	9/118 (7.63%)
General disorders
Nausea † 1	6/118 (5.08%)
Vomiting † 1	7/118 (5.93%)
Infections and infestations
Nasopharyngitis † 1	9/118 (7.63%)
Metabolism and nutrition disorders
Increased appetite † 1	7/118 (5.93%)
Nervous system disorders
Dizziness † 1	9/118 (7.63%)
Headache † 1	20/118 (16.95%)
Psychiatric disorders
Insomnia † 1	10/118 (8.47%)
Respiratory, thoracic and mediastinal disorders
Nasal congestion † 1	7/118 (5.93%)
† Indicates events were collected by systematic assessment; 1 Term from vocabulary, MedDRA (15.1)

Limitations and Caveats

[Not Specified]

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.

All data generated in this study will be the property of Forest Research Institute, Inc. An integrated clinical and statistical report will be prepared at the completion of the study.

Publication of the results by the Investigator will be subject to mutual agreement between the Investigator and Forest Research Institute, Inc.

Results Point of Contact

Name/Title: Carl Gommoll, MS, Sr. Dir. Clinical Development Psychiatry

Organization: Forest Research Institute

Phone: 201-427-8000 ext 58124

EMail: carl.gommoll@frx.com

Responsible Party:	Forest Laboratories
ClinicalTrials.gov Identifier:	NCT01198795 History of Changes
Other Study ID Numbers:	SCT-MD-55
First Submitted:	September 9, 2010
First Posted:	September 10, 2010
Results First Submitted:	January 31, 2014
Results First Posted:	March 14, 2014
Last Update Posted:	March 14, 2014