Trial Outcomes & Findings for Safety Study of Escitalopram in Children 7 to 11 Years of Age With Major Depressive Disorder (NCT NCT01198795)

NCT ID: NCT01198795

Last Updated: 2014-03-14

Results Overview

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,

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 162 participants
• Primary outcome timeframe: From Baseline (Week 0) to Week 26
• Results posted on: 2014-03-14

Participant Flow

Patient recruitment occurred at 16 studies sites located in the US from October of 2010 to August of 2012.

All patients completed a 1-week no-drug screening period before beginning treatment with study drug.

Participant milestones

Measure	Escitalopram Flexible-dose 10mg-20mg once-daily oral (10mg tablets) dose of escitalopram for 24-weeks, with a 2-week downtaper period.
Overall Study STARTED	162
Overall Study COMPLETED	80
Overall Study NOT COMPLETED	82

Reasons for withdrawal

Measure	Escitalopram Flexible-dose 10mg-20mg once-daily oral (10mg tablets) dose of escitalopram for 24-weeks, with a 2-week downtaper period.
Overall Study Did not meet InclusionExclusion criteria	30
Overall Study Withdrawal by Subject	17
Overall Study Lost to Follow-up	15
Overall Study Adverse Event	9
Overall Study Lack of Efficacy	5
Overall Study Protocol Violation	2
Overall Study Other Reason	4

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	Escitalopram n=118 Participants Flexible-dose 10mg-20mg once-daily oral (10mg tablets) dose of escitalopram for 24-weeks, with a 2-week downtaper period.
Age, Continuous	9.4 Years STANDARD_DEVIATION 1.2 • n=5 Participants
Age, Customized Ages 7 Years to 8 Years	31 participants n=5 Participants
Age, Customized Ages 9 Years to 10 Years	62 participants n=5 Participants
Age, Customized Age 11 Years	25 participants n=5 Participants
Sex: Female, Male Female	53 Participants n=5 Participants
Sex: Female, Male Male	65 Participants n=5 Participants
Race/Ethnicity, Customized White	85 participants n=5 Participants
Race/Ethnicity, Customized Black	26 participants n=5 Participants
Race/Ethnicity, Customized Asian	1 participants n=5 Participants
Race/Ethnicity, Customized American Indian or Alaska Native	1 participants n=5 Participants
Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander	1 participants n=5 Participants
Race/Ethnicity, Customized Other	4 participants n=5 Participants
Race/Ethnicity, Customized Hispanic or Latino	16 participants n=5 Participants
Race/Ethnicity, Customized Not Hispanic or Latino	102 participants n=5 Participants
Region of Enrollment United States	118 participants n=5 Participants
Weight, mean	42.71 kg STANDARD_DEVIATION 16.67 • n=5 Participants
Height, mean	141.27 cm STANDARD_DEVIATION 10.22 • n=5 Participants
BMI(Body Mass Index), mean	20.86 kg/m2 STANDARD_DEVIATION 5.83 • n=5 Participants

PRIMARY outcome

Timeframe: From Baseline (Week 0) to Week 26

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,

Outcome measures

Measure	Escitalopram n=118 Participants Flexible-dose 10mg-20mg once-daily oral (10mg tablets) dose of escitalopram for 24-weeks, with a 2-week downtaper period.
Patients With Any Treatment Emergent Adverse Events (TEAEs)	89 participants

Adverse Events

Escitalopram

Serious events: 2 serious events

Other events: 59 other events

Deaths: 0 deaths

Serious adverse events

Measure	Escitalopram n=118 participants at risk Flexible-dose 10mg-20mg once-daily oral (10mg tablets) dose of escitalopram for 24-weeks, with a 2-week downtaper period.
Psychiatric disorders Mania	0.85% 1/118 • Adverse event data was collected during a 28 month period from October 2010 to February 2013.
Psychiatric disorders Suicidal Ideation	0.85% 1/118 • Adverse event data was collected during a 28 month period from October 2010 to February 2013.

Other adverse events

Measure	Escitalopram n=118 participants at risk Flexible-dose 10mg-20mg once-daily oral (10mg tablets) dose of escitalopram for 24-weeks, with a 2-week downtaper period.
Gastrointestinal disorders Abdominal pain upper	11.0% 13/118 • Adverse event data was collected during a 28 month period from October 2010 to February 2013.
Gastrointestinal disorders Diarrhea	7.6% 9/118 • Adverse event data was collected during a 28 month period from October 2010 to February 2013.
General disorders Nausea	5.1% 6/118 • Adverse event data was collected during a 28 month period from October 2010 to February 2013.
General disorders Vomiting	5.9% 7/118 • Adverse event data was collected during a 28 month period from October 2010 to February 2013.
Infections and infestations Nasopharyngitis	7.6% 9/118 • Adverse event data was collected during a 28 month period from October 2010 to February 2013.
Metabolism and nutrition disorders Increased appetite	5.9% 7/118 • Adverse event data was collected during a 28 month period from October 2010 to February 2013.
Nervous system disorders Dizziness	7.6% 9/118 • Adverse event data was collected during a 28 month period from October 2010 to February 2013.
Nervous system disorders Headache	16.9% 20/118 • Adverse event data was collected during a 28 month period from October 2010 to February 2013.
Psychiatric disorders Insomnia	8.5% 10/118 • Adverse event data was collected during a 28 month period from October 2010 to February 2013.
Respiratory, thoracic and mediastinal disorders Nasal congestion	5.9% 7/118 • Adverse event data was collected during a 28 month period from October 2010 to February 2013.

Additional Information

Carl Gommoll, MS, Sr. Dir. Clinical Development Psychiatry

Forest Research Institute

Phone: 201-427-8000

Email: carl.gommoll@frx.com

Results disclosure agreements

• Principal investigator is a sponsor employee 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.
• Publication restrictions are in place

Restriction type: OTHER