Trial Outcomes & Findings for The Safety and Efficacy of Escitalopram in Pediatric Patients With Major Depressive Disorder (NCT NCT00107120)
NCT ID: NCT00107120
Last Updated: 2012-04-06
Results Overview
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.
COMPLETED
PHASE3
312 participants
Baseline to end of week 8
2012-04-06
Participant Flow
Recruitment period was from April 1, 2005 through March, 2007 at 40 centers in the US.
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).
Participant milestones
| Measure |
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
|
|---|---|---|
|
Overall Study
STARTED
|
155
|
157
|
|
Overall Study
COMPLETED
|
126
|
133
|
|
Overall Study
NOT COMPLETED
|
29
|
24
|
Reasons for withdrawal
| Measure |
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
|
|---|---|---|
|
Overall Study
Adverse Event
|
4
|
1
|
|
Overall Study
Lack of Efficacy
|
5
|
5
|
|
Overall Study
Protocol Violation
|
3
|
0
|
|
Overall Study
Withdrawal by Subject
|
8
|
9
|
|
Overall Study
Lost to Follow-up
|
8
|
6
|
|
Overall Study
Pregnancy
|
0
|
1
|
|
Overall Study
moving away from site
|
1
|
1
|
|
Overall Study
death of parent
|
0
|
1
|
Baseline Characteristics
The Safety and Efficacy of Escitalopram in Pediatric Patients With Major Depressive Disorder
Baseline characteristics by cohort
| Measure |
Escitalopram
n=155 Participants
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
n=157 Participants
Once daily oral administration of placebo tablets
|
Total
n=312 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
155 Participants
n=5 Participants
|
157 Participants
n=7 Participants
|
312 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age Continuous
|
14.7 years
STANDARD_DEVIATION 1.6 • n=5 Participants
|
14.5 years
STANDARD_DEVIATION 1.5 • n=7 Participants
|
14.6 years
STANDARD_DEVIATION 1.6 • n=5 Participants
|
|
Sex: Female, Male
Female
|
92 Participants
n=5 Participants
|
92 Participants
n=7 Participants
|
184 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
63 Participants
n=5 Participants
|
65 Participants
n=7 Participants
|
128 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
155 participants
n=5 Participants
|
157 participants
n=7 Participants
|
312 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline to end of week 8Population: 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.
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.
Outcome measures
| Measure |
Escitalopram
n=154 Participants
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
n=157 Participants
Once daily oral administration of placebo tablets
|
|---|---|---|
|
Change in Children's Depression Rating Scale - Revised (CDRS-R) Total Score
|
-22.4 Change in total score at endpoint
Standard Error 1.1
|
-18.4 Change in total score at endpoint
Standard Error 1.1
|
SECONDARY outcome
Timeframe: CGI-I score at the end of Week 8Population: The Intent-To-Treat Population was used. The Last Observation Carried Forward (LOCF) technique was used to impute missing data.
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).
Outcome measures
| Measure |
Escitalopram
n=154 Participants
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
n=157 Participants
Once daily oral administration of placebo tablets
|
|---|---|---|
|
Clinical Global Impressions - Improvement
|
2.2 Score on scale
Standard Error 0.1
|
2.5 Score on scale
Standard Error 0.1
|
OTHER_PRE_SPECIFIED outcome
Timeframe: At baseline and end of week 8Population: The Intent-To-Treat Population was used. The Last Observation Carried Forward (LOCF) technique was used to impute missing data.
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).
Outcome measures
| Measure |
Escitalopram
n=154 Participants
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
n=157 Participants
Once daily oral administration of placebo tablets
|
|---|---|---|
|
Children's Global Assessment Scale
|
14.7 Change in score
Standard Error 1.0
|
12.4 Change in score
Standard Error 1.0
|
Adverse Events
Escitalopram
Placebo
Serious adverse events
| Measure |
Escitalopram
n=155 participants at risk
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
n=157 participants at risk
Once daily oral administration of placebo tablets
|
|---|---|---|
|
General disorders
Inflicted Injury
|
1.3%
2/155
|
0.00%
0/157
|
|
Psychiatric disorders
Irritability
|
0.65%
1/155
|
0.00%
0/157
|
|
Psychiatric disorders
Suicidal Tendency
|
0.65%
1/155
|
0.64%
1/157
|
|
Psychiatric disorders
Depression Aggravated
|
0.00%
0/155
|
0.64%
1/157
|
Other adverse events
| Measure |
Escitalopram
n=155 participants at risk
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
n=157 participants at risk
Once daily oral administration of placebo tablets
|
|---|---|---|
|
Nervous system disorders
Headache
|
25.2%
39/155
|
25.5%
40/157
|
|
Psychiatric disorders
Insomnia
|
10.3%
16/155
|
6.4%
10/157
|
|
Gastrointestinal disorders
Nausea
|
10.3%
16/155
|
8.3%
13/157
|
|
Gastrointestinal disorders
Abdominal Pain
|
9.0%
14/155
|
7.0%
11/157
|
|
General disorders
Inflicted Injury
|
9.0%
14/155
|
13.4%
21/157
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngitis
|
8.4%
13/155
|
9.6%
15/157
|
|
General disorders
Fatigue
|
7.7%
12/155
|
8.3%
13/157
|
|
General disorders
Influenza-like Symptoms
|
7.1%
11/155
|
3.2%
5/157
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis
|
7.1%
11/155
|
8.9%
14/157
|
|
Reproductive system and breast disorders
Menstrual Cramps
|
6.5%
10/155
|
8.9%
14/157
|
|
Gastrointestinal disorders
Vomiting
|
6.5%
10/155
|
5.7%
9/157
|
|
Gastrointestinal disorders
Diarrhoea
|
5.2%
8/155
|
3.2%
5/157
|
|
Respiratory, thoracic and mediastinal disorders
Upper Respiratory Tract Infections
|
5.2%
8/155
|
7.6%
12/157
|
Additional Information
Daniel Ventura, PhD
Forest Research Institute, a subsidiary of Forest Laboratories, Inc.
Results disclosure agreements
- Principal investigator is a sponsor employee 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.
- Publication restrictions are in place
Restriction type: OTHER