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Trial record 28 of 468 for:    ESCITALOPRAM AND Cholinergic

Safety Study of Escitalopram in Children 7 to 11 Years of Age 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.
 
ClinicalTrials.gov Identifier: NCT01198795
Recruitment Status : Completed
First Posted : September 10, 2010
Results First Posted : March 14, 2014
Last Update Posted : March 14, 2014
Sponsor:
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
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
Hide 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
Arm/Group Title Escitalopram
Hide 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
Hide 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)
1.Primary Outcome
Title Patients With Any Treatment Emergent Adverse Events (TEAEs)
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Escitalopram
Hide 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
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
Hide 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   --/-- 
Show Serious Adverse Events Hide 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)
Show Other (Not Including Serious) Adverse Events Hide 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)
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
Layout table for Results Point of Contact information
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
Layout table for additonal information
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