Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

The Safety and Efficacy of Escitalopram in Pediatric Patients 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: NCT00107120
Recruitment Status : Completed
First Posted : April 6, 2005
Results First Posted : November 4, 2009
Last Update Posted : April 6, 2012
Sponsor:
Information provided by (Responsible Party):
Forest Laboratories

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Major Depressive Disorder
Interventions Drug: Escitalopram
Drug: Placebo
Enrollment 312
Recruitment Details Recruitment period was from April 1, 2005 through March, 2007 at 40 centers in the US.
Pre-assignment Details 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).
Arm/Group Title Escitalopram Placebo
Hide Arm/Group Description 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. Once daily oral administration of placebo tablets
Period Title: Overall Study
Started 155 [1] 157 [1]
Completed 126 133
Not Completed 29 24
Reason Not Completed
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
Arm/Group Title Escitalopram Placebo Total
Hide Arm/Group Description 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. Once daily oral administration of placebo tablets Total of all reporting groups
Overall Number of Baseline Participants 155 157 312
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 155 participants 157 participants 312 participants
<=18 years
155
 100.0%
157
 100.0%
312
 100.0%
Between 18 and 65 years
0
   0.0%
0
   0.0%
0
   0.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 155 participants 157 participants 312 participants
14.7  (1.6) 14.5  (1.5) 14.6  (1.6)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 155 participants 157 participants 312 participants
Female
92
  59.4%
92
  58.6%
184
  59.0%
Male
63
  40.6%
65
  41.4%
128
  41.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 155 participants 157 participants 312 participants
155 157 312
1.Primary Outcome
Title Change in Children's Depression Rating Scale - Revised (CDRS-R) Total Score
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Escitalopram Placebo
Hide Arm/Group Description:
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.
Once daily oral administration of placebo tablets
Overall Number of Participants Analyzed 154 157
Mean (Standard Error)
Unit of Measure: Change in total score at endpoint
-22.4  (1.1) -18.4  (1.1)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Escitalopram, Placebo
Comments 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.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.022
Comments Two-sided at 5% level of significance p < 0.05 considered significant
Method ANCOVA
Comments The model included study center and treatment as factors and baseline core as covariate
Method of Estimation Estimation Parameter Least Square Means Difference
Estimated Value -3.4
Confidence Interval 95%
-6.2 to -0.5
Parameter Dispersion
Type: Standard Error of the mean
Value: 1.458
Estimation Comments Differences are Escitalopram-Placebo
2.Secondary Outcome
Title Clinical Global Impressions - Improvement
Hide Description Clinical Global Impressions - Improvement score at the end of week 8. The scale rates improvement or worsening of patient mental health relative to baseline on a scale from 1 (very much improved) to 7 (very much worse).
Time Frame CGI-I score at the end of Week 8
Hide Outcome Measure Data
Hide Analysis Population Description
The Intent-To-Treat Population was used. The Last Observation Carried Forward (LOCF) technique was used to impute missing data.
Arm/Group Title Escitalopram Placebo
Hide Arm/Group Description:
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.
Once daily oral administration of placebo tablets
Overall Number of Participants Analyzed 154 157
Mean (Standard Error)
Unit of Measure: Score on scale
2.2  (0.1) 2.5  (0.1)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Escitalopram, Placebo
Comments Missing values were imputed using the LOCF approach.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.008
Comments Two-sided at 5% level of significance
Method ANCOVA
Comments The model included treatment and center as factors and baseline CGI-Severity score as covariate.
Method of Estimation Estimation Parameter Least Square Means Difference
Estimated Value -0.344
Confidence Interval 95%
-0.595 to 0.092
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.1128
Estimation Comments Differences are Escitalopram-Placebo
3.Other Pre-specified Outcome
Title Children's Global Assessment Scale
Hide Description Change from baseline to week 8 in CGAS score which rates the patient's general level of functioning for the past 14 days on a scale of 1 (most impaired) to 100 (healthiest).
Time Frame At baseline and end of week 8
Hide Outcome Measure Data
Hide Analysis Population Description
The Intent-To-Treat Population was used. The Last Observation Carried Forward (LOCF) technique was used to impute missing data.
Arm/Group Title Escitalopram Placebo
Hide Arm/Group Description:
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.
Once daily oral administration of placebo tablets
Overall Number of Participants Analyzed 154 157
Mean (Standard Error)
Unit of Measure: Change in score
14.7  (1.0) 12.4  (1.0)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Escitalopram, Placebo
Comments ANCOVA on the Change from Baseline to Week 8 in CGAS score. The model included treatment and center as factors and baseline score as covariate. Missing values were imputed using the LOCF approach.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.103
Comments Two-sided at 5% level of significance
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Least Square Means Difference
Estimated Value 2.169
Confidence Interval 95%
-0.439 to 4.777
Parameter Dispersion
Type: Standard Error of the mean
Value: 1.324
Estimation Comments Differences are Escitalopram-Placebo
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Escitalopram Placebo
Hide Arm/Group Description 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. Once daily oral administration of placebo tablets
All-Cause Mortality
Escitalopram Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Escitalopram Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   4/155 (2.58%)   2/157 (1.27%) 
General disorders     
Inflicted Injury * 1  2/155 (1.29%)  0/157 (0.00%) 
Psychiatric disorders     
Irritability * 1  1/155 (0.65%)  0/157 (0.00%) 
Suicidal Tendency * 1  1/155 (0.65%)  1/157 (0.64%) 
Depression Aggravated * 1  0/155 (0.00%)  1/157 (0.64%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, WHOART v.1998/04
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Escitalopram Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   121/155 (78.06%)   118/157 (75.16%) 
Gastrointestinal disorders     
Nausea * 1  16/155 (10.32%)  13/157 (8.28%) 
Abdominal Pain * 1  14/155 (9.03%)  11/157 (7.01%) 
Vomiting * 1  10/155 (6.45%)  9/157 (5.73%) 
Diarrhoea * 1  8/155 (5.16%)  5/157 (3.18%) 
General disorders     
Inflicted Injury * 1  14/155 (9.03%)  21/157 (13.38%) 
Fatigue * 1  12/155 (7.74%)  13/157 (8.28%) 
Influenza-like Symptoms * 1  11/155 (7.10%)  5/157 (3.18%) 
Nervous system disorders     
Headache * 1  39/155 (25.16%)  40/157 (25.48%) 
Psychiatric disorders     
Insomnia * 1  16/155 (10.32%)  10/157 (6.37%) 
Reproductive system and breast disorders     
Menstrual Cramps * 1  10/155 (6.45%)  14/157 (8.92%) 
Respiratory, thoracic and mediastinal disorders     
Pharyngitis * 1  13/155 (8.39%)  15/157 (9.55%) 
Rhinitis * 1  11/155 (7.10%)  14/157 (8.92%) 
Upper Respiratory Tract Infections * 1  8/155 (5.16%)  12/157 (7.64%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, WHOART v.1998/04
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.
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.
Results Point of Contact
Name/Title: Daniel Ventura, PhD
Organization: Forest Research Institute, a subsidiary of Forest Laboratories, Inc.
Phone: 201-427-8252
Responsible Party: Forest Laboratories
ClinicalTrials.gov Identifier: NCT00107120     History of Changes
Other Study ID Numbers: SCT-MD-32
First Submitted: April 5, 2005
First Posted: April 6, 2005
Results First Submitted: April 21, 2009
Results First Posted: November 4, 2009
Last Update Posted: April 6, 2012