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Trial record 16 of 27 for:    Edivoxetine OR LY2216684

A Study of Pediatric Participants With Attention Deficit/Hyperactivity 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: NCT00965419
Recruitment Status : Terminated (Terminated due to low 5 year completer number and not meeting primary objective.)
First Posted : August 25, 2009
Results First Posted : April 27, 2018
Last Update Posted : April 27, 2018
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Attention Deficit Hyperactivity Disorder
Intervention Drug: Edivoxetine
Enrollment 267
Recruitment Details  
Pre-assignment Details All enrolled participants that received edivoxetine during the open-label treatment phase for up to 5 years and follow-up phase.
Arm/Group Title Edivoxetine
Hide Arm/Group Description Edivoxetine: 0.1 milligram (mg)/kilogram (kg)/day or participant specific known stable dose, rollover participants (LNBJ [No NCT number]) and (LNBF [NCT00922636]), up to 0.3 mg/kg/day, oral, daily for up to 5 years.
Period Title: Open Label Treatment for Responders
Started 267
Not Lost to f/u at First Post-baseline 264
Completed 20
Not Completed 247
Reason Not Completed
Adverse Event             33
Entry Criteria Not Met             1
Protocol Violation             21
Withdrawal by Subject             27
Physician Decision             6
Sponsor Decision             5
Parent/Caregiver Decision             41
Lack of Efficacy             67
Lost to Follow-up             46
Period Title: Follow-up Phase
Started [1] 80
Completed 18
Not Completed 62
Reason Not Completed
Adverse Event             9
Protocol Violation             4
Withdrawal by Subject             8
Physician Decision             4
Parent/Caregiver Decision             9
Lack of Efficacy             28
[1]
Participants who dropped out of treatment period early had the option to enter follow-up period.
Arm/Group Title All Participants
Hide Arm/Group Description Edivoxetine: 0.1 mg/kg/day or participant specific known stable dose (rollover participants) up to 0.3 mg/kg/day, oral, daily for up to 5 years.
Overall Number of Baseline Participants 267
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 267 participants
11.64  (2.99)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 267 participants
Female
79
  29.6%
Male
188
  70.4%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 267 participants
Hispanic or Latino
65
  24.3%
Not Hispanic or Latino
202
  75.7%
Unknown or Not Reported
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 267 participants
American Indian or Alaska Native
2
   0.7%
Asian
11
   4.1%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
60
  22.5%
White
180
  67.4%
More than one race
14
   5.2%
Unknown or Not Reported
0
   0.0%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 267 participants
Canada
9
   3.4%
Puerto Rico
11
   4.1%
United States
235
  88.0%
Taiwan
10
   3.7%
Mexico
2
   0.7%
1.Primary Outcome
Title Percentage of Participants With At Least One Serious Adverse Events (SAE) Over the Duration of the Study
Hide Description Percentage of Participants experienced at least one SAE during the study. A summary of other nonserious AEs, and all SAE's, regardless of causality, is located in the Reported Adverse Events section.
Time Frame Baseline Through Week 252
Hide Outcome Measure Data
Hide Analysis Population Description
All enrolled participants who did not discontinue from the study for the reason 'Lost to follow up' at the first post-baseline observation and who had baseline and at least one post-baseline SAE assessment.
Arm/Group Title Edivoxetine
Hide Arm/Group Description:
Edivoxetine: 0.1 mg/kg/day or participant specific known stable dose (rollover participants) up to 0.3 mg/kg/day, oral, daily for up to 5 years.
Overall Number of Participants Analyzed 264
Measure Type: Number
Unit of Measure: percentage of participants
2.65
2.Primary Outcome
Title Number of Participants With At Least One SAE
Hide Description Number of Participants experienced at least one SAE during the study. A summary of other nonserious AEs, and all SAE's, regardless of causality, is located in the Reported Adverse Events section.
Time Frame Baseline Through Week 252
Hide Outcome Measure Data
Hide Analysis Population Description
All enrolled participants who did not discontinue from the study for the reason 'Lost to follow up' at the first post-baseline observation and who had baseline and at least one post-baseline SAE assessment.
Arm/Group Title Edivoxetine
Hide Arm/Group Description:
Edivoxetine: 0.1 mg/kg/day or participant specific known stable dose (rollover participants) up to 0.3 mg/kg/day, oral, daily for up to 5 years.
Overall Number of Participants Analyzed 264
Measure Type: Count of Participants
Unit of Measure: Participants
7
3.Secondary Outcome
Title Percentage of Participants With Treatment-emergent Adverse Events (TEAEs)
Hide Description Percentage of Participants had at least one TEAE during the study. A summary of other nonserious AEs, and all SAE's, regardless of causality, is located in the Reported Adverse Events section.
Time Frame Baseline Through Week 252
Hide Outcome Measure Data
Hide Analysis Population Description
All enrolled participants who did not discontinue from the study for the reason 'Lost to follow up' at the first post-baseline observation and who had baseline and at least one post-baseline TEAE assessment.
Arm/Group Title Edivoxetine
Hide Arm/Group Description:
Edivoxetine: 0.1 mg/kg/day or participant specific known stable dose (rollover participants) up to 0.3 mg/kg/day, oral, daily for up to 5 years.
Overall Number of Participants Analyzed 264
Measure Type: Number
Unit of Measure: percentage of participants
76.89
4.Secondary Outcome
Title Number of Participants With At Least One TEAE
Hide Description Number of participants had at least one TEAE during the study. A summary of other nonserious AEs, and all SAE's, regardless of causality, is located in the Reported Adverse Events section.
Time Frame Baseline Through Week 252
Hide Outcome Measure Data
Hide Analysis Population Description
All enrolled participants who did not discontinue from the study for the reason 'Lost to follow up' at the first post-baseline observation and who had baseline and at least one post-baseline TEAE assessment.
Arm/Group Title Edivoxetine
Hide Arm/Group Description:
Edivoxetine: 0.1 mg/kg/day or participant specific known stable dose (rollover participants) up to 0.3 mg/kg/day, oral, daily for up to 5 years.
Overall Number of Participants Analyzed 264
Measure Type: Count of Participants
Unit of Measure: Participants
203
5.Secondary Outcome
Title Percentage of Participants With Discontinuation Due to Adverse Events (DCAEs)
Hide Description [Not Specified]
Time Frame Baseline Through Week 252
Hide Outcome Measure Data
Hide Analysis Population Description
All enrolled participants who did not discontinue from the study for the reason 'Lost to follow up' at the first post-baseline observation.
Arm/Group Title Edivoxetine
Hide Arm/Group Description:
Edivoxetine: 0.1 mg/kg/day or participant specific known stable dose (rollover participants) up to 0.3 mg/kg/day, oral, daily for up to 5 years.
Overall Number of Participants Analyzed 264
Measure Type: Number
Unit of Measure: percentage of participants
12.50
6.Secondary Outcome
Title Number of Participants With At Least One DCAEs
Hide Description [Not Specified]
Time Frame Baseline Through Week 252
Hide Outcome Measure Data
Hide Analysis Population Description
All enrolled participants who did not discontinue from the study for the reason 'Lost to follow up' at the first post-baseline observation and who had baseline and at least one post-baseline DCAE assessment.
Arm/Group Title Edivoxetine
Hide Arm/Group Description:
Edivoxetine: 0.1 mg/kg/day or participant specific known stable dose (rollover participants) up to 0.3 mg/kg/day, oral, daily for up to 5 years.
Overall Number of Participants Analyzed 264
Measure Type: Count of Participants
Unit of Measure: Participants
33
7.Secondary Outcome
Title Percentage of Participants Who Discontinued Due to Any Reason
Hide Description [Not Specified]
Time Frame Baseline Through Week 252
Hide Outcome Measure Data
Hide Analysis Population Description
All enrolled participants who had evaluable discontinuation data.
Arm/Group Title Edivoxetine
Hide Arm/Group Description:
Edivoxetine: 0.1 mg/kg/day or participant specific known stable dose (rollover participants) up to 0.3 mg/kg/day, oral, daily for up to 5 years.
Overall Number of Participants Analyzed 267
Measure Type: Number
Unit of Measure: Percentage of participants
92.51
8.Secondary Outcome
Title Number of Participants Who Discontinued Due to Any Reason
Hide Description [Not Specified]
Time Frame Baseline Through Week 252
Hide Outcome Measure Data
Hide Analysis Population Description
All enrolled participants who had evaluable discontinuation data.
Arm/Group Title Edivoxetine
Hide Arm/Group Description:
Edivoxetine: 0.1 mg/kg/day or participant specific known stable dose (rollover participants) up to 0.3 mg/kg/day, oral, daily for up to 5 years.
Overall Number of Participants Analyzed 267
Measure Type: Count of Participants
Unit of Measure: Participants
247
9.Secondary Outcome
Title Percentage of Participants With Columbia-Suicide Severity Rating Scale (CSSRS) for Each Category
Hide Description Percentage of Participants in each category of CSSRS captures the occurrence, severity, and frequency of suicide-related thoughts and behaviors during the assessment period. Participants with suicidal ideation were those who had yes to any of the following questions: Wish to be dead, non-specific active suicidal thoughts, active suicidal ideation with any methods (not plan) without intent to act, active suicidal ideation with some intent to act, without specific plan, and active suicidal ideation with specific plan and intent. Suicidal behavior included those who had yes to any of the following questions: Preparatory acts or behavior, Aborted attempt, Interrupted attempt, Non-fatal suicide attempt, Completed suicide.
Time Frame Baseline Through Week 252, Baseline, 1-month (mo) Follow-Up (f/u)
Hide Outcome Measure Data
Hide Analysis Population Description
All enrolled participants who did not discontinue from the study for the reason 'Lost to follow up' at the first post-baseline observation and who had baseline and at least one post-baseline CSSRS assessment.
Arm/Group Title Edivoxetine
Hide Arm/Group Description:
Edivoxetine: 0.1 mg/kg/day or participant specific known stable dose (rollover participants) up to 0.3 mg/kg/day, oral, daily for up to 5 years.
Overall Number of Participants Analyzed 264
Measure Type: Number
Unit of Measure: percentage of participants
0-5 Years (Suicidal Ideation) Number Analyzed 264 participants
5.68
0-5 Years (Suicidal Behavior) Number Analyzed 264 participants
0.00
0-5 Yrs (Non-suicidal self-injurious) Number Analyzed 264 participants
0.38
1 month f/u (Suicidal Ideation) Number Analyzed 79 participants
1.27
1 month f/u (Suicidal Behavior) Number Analyzed 79 participants
0.00
1 mo f/u (Non-suicidal self-injurious behavior) Number Analyzed 79 participants
0.00
10.Secondary Outcome
Title Mean Change From Baseline Z-scores for Height
Hide Description A z-score is the number of standard deviations a data point is from the mean. Z-scores range from -3 standard deviations (far left of the mean in normal distribution curve) up to +3 standard deviations (far right of the mean in normal distribution curve).
Time Frame Baseline, Week 60; Baseline, Week 240
Hide Outcome Measure Data
Hide Analysis Population Description
All enrolled participants who did not discontinue from the study for the reason 'Lost to follow up' at the first post-baseline observation and who had baseline and at least one post-baseline Z-score assessment.
Arm/Group Title Edivoxetine
Hide Arm/Group Description:
Edivoxetine: 0.1 mg/kg/day or participant specific known stable dose (rollover participants) up to 0.3 mg/kg/day, oral, daily for up to 5 years.
Overall Number of Participants Analyzed 264
Mean (Standard Deviation)
Unit of Measure: Z-Score
Week 60 Number Analyzed 104 participants
-0.05  (0.36)
Week 240 Number Analyzed 24 participants
-0.11  (0.53)
11.Secondary Outcome
Title Mean Change From Baseline Z-Score for Weight
Hide Description A z-score is the number of standard deviations a data point is from the mean. Z-scores range from -3 standard deviations (far left of the mean in normal distribution curve) up to +3 standard deviations (far right of the mean in normal distribution curve).
Time Frame Baseline, Week 60; Baseline, Week 240
Hide Outcome Measure Data
Hide Analysis Population Description
All enrolled participants who did not discontinue from the study for the reason 'Lost to follow up' at the first post-baseline observation and who had baseline and at least one post-baseline Z-score assessment.
Arm/Group Title Edivoxetine
Hide Arm/Group Description:
Edivoxetine: 0.1 mg/kg/day or participant specific known stable dose (rollover participants) up to 0.3 mg/kg/day, oral, daily for up to 5 years.
Overall Number of Participants Analyzed 264
Mean (Standard Deviation)
Unit of Measure: Z-Score
Week 60 Number Analyzed 104 participants
-0.17  (0.37)
Week 240 Number Analyzed 24 participants
-0.25  (0.77)
12.Secondary Outcome
Title Mean Change From Baseline Z-Score in Body Mass Index (BMI)
Hide Description [Not Specified]
Time Frame Baseline, Week 60; Baseline, Week 240
Hide Outcome Measure Data
Hide Analysis Population Description
All enrolled participants who did not discontinue from the study for the reason 'Lost to follow up' at the first post-baseline observation and who had baseline and at least one post-baseline Z-score assessment.
Arm/Group Title Edivoxetine
Hide Arm/Group Description:
Edivoxetine: 0.1 mg/kg/day or participant specific known stable dose (rollover participants) up to 0.3 mg/kg/day, oral, daily for up to 5 years.
Overall Number of Participants Analyzed 264
Mean (Standard Deviation)
Unit of Measure: Z-Score
Week 60 Number Analyzed 104 participants
-0.20  (0.40)
Week 240 Number Analyzed 24 participants
-0.32  (0.83)
13.Secondary Outcome
Title Percentage of Participants With Response Rates
Hide Description [Not Specified]
Time Frame Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Zero participants were analyzed for this outcome measure, due to all participants being roll-over from two previous edivoxetine trials (LNBJ [No NCT number]) and (LNBF [NCT00922636])This outcome measure and analysis was not applicable to roll-over participants.
Arm/Group Title Edivoxetine
Hide Arm/Group Description:
Edivoxetine: 0.1 mg/kg/day or participant specific known stable dose (rollover participants) up to 0.3 mg/kg/day, oral, daily for up to 5 years.
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
14.Secondary Outcome
Title Number of Participants With a Response Rate
Hide Description [Not Specified]
Time Frame Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Zero participants were analyzed for this outcome measure. Data was not collected for this outcome for participants due to all participants being roll-over from two previous edivoxetine trials (LNBJ [No NCT number]) and (LNBF [NCT00922636]). This outcome measure was not applicable to roll-over participants.
Arm/Group Title Edivoxetine
Hide Arm/Group Description:
Edivoxetine: 0.1 mg/kg/day or participant specific known stable dose (rollover participants) up to 0.3 mg/kg/day, oral, daily for up to 5 years.
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
15.Secondary Outcome
Title Survival Curve Time to Response
Hide Description [Not Specified]
Time Frame Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Zero participants were analyzed for this outcome measure. Data was not collected for this outcome for participants due to all participants being roll-over from two previous edivoxetine trials (LNBJ [No NCT number]) and (LNBF [NCT00922636]). This outcome measure was not applicable to roll-over participants.
Arm/Group Title Edivoxetine
Hide Arm/Group Description:
Edivoxetine: 0.1 mg/kg/day or participant specific known stable dose (rollover participants) up to 0.3 mg/kg/day, oral, daily for up to 5 years.
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
16.Secondary Outcome
Title Percentage of Participants in Sexual Maturation on Tanners Scale
Hide Description Participant's stage of sexual maturation were assessed using the Tanner staging measure for determining pubertal development in male and female participants. Tanner staging includes a self-assessment of pubic hair development (both males and females), genital development (males), and breast development (females). Tanner stage (pubic) is a score of range 1-5 where 1=no development and 5=adult pubic hair. Tanner stage (breast) is a score of range 1-5 where 1=no development and 5=adult breast. Tanner stages (1-5) were used to characterize physical development in children, adolescents, and adults. The stages were based on external primary and secondary sex characteristics, such as the size of the breasts, genitalia, and development of pubic hair. Tanner stage is considered going up when the organs grow bigger.
Time Frame Baseline Up to Week 252
Hide Outcome Measure Data
Hide Analysis Population Description
All enrolled participants who did not discontinue from the study for the reason 'Lost to follow up' at the first post-baseline observation and who had baseline and at least one post-baseline Tanners scale assessment.
Arm/Group Title Edivoxetine
Hide Arm/Group Description:
Edivoxetine: 0.1 mg/kg/day or participant specific known stable dose (rollover participants) up to 0.3 mg/kg/day, oral, daily for up to 5 years.
Overall Number of Participants Analyzed 264
Measure Type: Number
Unit of Measure: percentage of participants
Pubic Hair Male Tanner I Number Analyzed 100 participants
25.00
Pubic Hair Male Tanner II Number Analyzed 100 participants
11.00
Pubic Hair Male Tanner III Number Analyzed 100 participants
10.00
Pubic Hair Male Tanner IV Number Analyzed 100 participants
23.00
Pubic Hair Male Tanner V Number Analyzed 100 participants
31.00
Pubic Hair Female Tanner I Number Analyzed 48 participants
12.50
Pubic Hair Female Tanner II Number Analyzed 48 participants
14.58
Pubic Hair Female Tanner III Number Analyzed 48 participants
6.25
Pubic Hair Female Tanner IV Number Analyzed 48 participants
20.83
Pubic Hair Female Tanner V Number Analyzed 48 participants
45.83
Genital Development Male Tanner I Number Analyzed 100 participants
22.00
Genital Development Male Tanner II Number Analyzed 100 participants
11.00
Genital Development Male Tanner III Number Analyzed 100 participants
18.00
Genital Development Male Tanner IV Number Analyzed 100 participants
17.00
Genital Development Male Tanner V Number Analyzed 100 participants
32.00
Breast Development Female Tanner I Number Analyzed 48 participants
16.67
Breast Development Female Tanner II Number Analyzed 48 participants
6.25
Breast Development Female Tanner III Number Analyzed 48 participants
16.67
Breast Development Female Tanner IV Number Analyzed 48 participants
22.92
Breast Development Female Tanner V Number Analyzed 48 participants
37.50
17.Secondary Outcome
Title Number of Participants in Sexual Maturation on Tanners Scale
Hide Description Participant's stage of sexual maturation were assessed using the Tanner staging measure for determining pubertal development in male and female participants. Tanner staging includes a self-assessment of pubic hair development (both males and females), genital development (males), and breast development (females). Tanner stage (pubic) is a score of range 1-5 where 1=no development and 5=adult pubic hair. Tanner stage (breast) is a score of range 1-5 where 1=no development and 5=adult breast. Tanner stages (1-5) were used to characterize physical development in children, adolescents, and adults. The stages were based on external primary and secondary sex characteristics, such as the size of the breasts, genitalia, and development of pubic hair. Tanner stage is considered going up when the organs grow bigger.
Time Frame Baseline Up to Week 252
Hide Outcome Measure Data
Hide Analysis Population Description
All enrolled participants who did not discontinue from the study for the reason 'Lost to follow up' at the first post-baseline observation and who had baseline and at least one post-baseline Tanners scale assessment.
Arm/Group Title Edivoxetine
Hide Arm/Group Description:
Edivoxetine: 0.1 mg/kg/day or participant specific known stable dose (rollover participants) up to 0.3 mg/kg/day, oral, daily for up to 5 years.
Overall Number of Participants Analyzed 264
Measure Type: Count of Participants
Unit of Measure: Participants
Pubic Hair Male Tanner I Number Analyzed 100 participants
25
Pubic Hair Male Tanner II Number Analyzed 100 participants
11
Pubic Hair Male Tanner III Number Analyzed 100 participants
10
Pubic Hair Male Tanner IV Number Analyzed 100 participants
23
Pubic Hair Male Tanner V Number Analyzed 100 participants
31
Pubic Hair Female Tanner I Number Analyzed 48 participants
6
Pubic Hair Female Tanner II Number Analyzed 48 participants
7
Pubic Hair Female Tanner III Number Analyzed 48 participants
3
Pubic Hair Female Tanner IV Number Analyzed 48 participants
10
Pubic Hair Female Tanner V Number Analyzed 48 participants
22
Genital Development Male Tanner I Number Analyzed 100 participants
22
Genital Development Male Tanner II Number Analyzed 100 participants
11
Genital Development Male Tanner III Number Analyzed 100 participants
18
Genital Development Male Tanner IV Number Analyzed 100 participants
17
Genital Development Male Tanner V Number Analyzed 100 participants
32
Breast Development Female Tanner I Number Analyzed 48 participants
8
Breast Development Female Tanner II Number Analyzed 48 participants
3
Breast Development Female Tanner III Number Analyzed 48 participants
8
Breast Development Female Tanner IV Number Analyzed 48 participants
11
Breast Development Female Tanner V Number Analyzed 48 participants
18
18.Secondary Outcome
Title Percentage of Participants With Tobacco, Alcohol and Marijuana Use
Hide Description [Not Specified]
Time Frame Week 60 through Week 252
Hide Outcome Measure Data
Hide Analysis Population Description
All enrolled participants who did not discontinue from the study for the reason 'Lost to follow up' at the first post-baseline observation and who had baseline and at least one post-baseline tobacco, alcohol, and marijuana use assessment.
Arm/Group Title Edivoxetine
Hide Arm/Group Description:
Edivoxetine: 0.1 mg/kg/day or participant specific known stable dose (rollover participants) up to 0.3 mg/kg/day, oral, daily for up to 5 years.
Overall Number of Participants Analyzed 264
Measure Type: Number
Unit of Measure: percentage of participants
Current Tobacco Use Week 60 Number Analyzed 104 participants
0
Current Alcohol Use Week 60 Number Analyzed 104 participants
0
Current Marijuana Use Week 60 Number Analyzed 104 participants
0
Current Tobacco Use Week 252 Number Analyzed 20 participants
0
Current Alcohol Use Week 252 Number Analyzed 20 participants
0
Current Marijuana Use Week 252 Number Analyzed 20 participants
0
19.Secondary Outcome
Title Number of Participants With Tobacco, Alcohol and Marijuana Use
Hide Description [Not Specified]
Time Frame Week 60 through Week 252
Hide Outcome Measure Data
Hide Analysis Population Description
All enrolled participants who did not discontinue from the study for the reason 'Lost to follow up' at the first post-baseline observation and who had baseline and at least one post-baseline tobacco, alcohol, and marijuana use assessment.
Arm/Group Title Edivoxetine
Hide Arm/Group Description:
Edivoxetine: 0.1 mg/kg/day or participant specific known stable dose (rollover participants) up to 0.3 mg/kg/day, oral, daily for up to 5 years.
Overall Number of Participants Analyzed 264
Measure Type: Count of Participants
Unit of Measure: Participants
Current Tobacco Use Week 60 Number Analyzed 104 participants
0
Current Alcohol Use Week 60 Number Analyzed 104 participants
0
Current Marijuana Use Week 60 Number Analyzed 104 participants
0
Current Tobacco Use Week 252 Number Analyzed 20 participants
0
Current Alcohol Use 252 Number Analyzed 20 participants
0
Current Marijuana Use Week 252 Number Analyzed 20 participants
0
20.Secondary Outcome
Title Mean Change From Baseline of Each Score Attention-Deficit/Hyperactivity Disorder Rating Scale-IV-Parent Version: Investigator Administered and Scored (ADHDRS-IV-Parent:Inv) (Hyperactive/Impulsive, Inattentive and Total Score)
Hide Description The ADHDRS-IV-Parent scale measures the 18 symptoms contained in the Diagnostic and Statistical Manual of Mental Disorders Fourth Edition, Text Revision (DSM-IV-TR) diagnosis of Attention-Deficit/Hyperactivity Disorder. Individual item scores range from 0 (none/never or rarely) to 3 (severe/very often). Total score is computed as the sum of the 18 items and ranges from 0 to 54. Inattention and Hyperactivity-Impulsivity subscales consisted of 9 items each, for total subscale scores ranging from 0 to 27. Higher total and subscale scores are indicative of more severe symptoms. Least-squares (LS) mean change from baseline was adjusted for repeated measure analysis included baseline score and visit time in the model.
Time Frame Baseline, Week 12; Baseline, Week 60; Baseline, Week 252
Hide Outcome Measure Data
Hide Analysis Population Description
All enrolled participants who did not discontinue from the study for the reason 'Lost to follow up' at the first post-baseline observation and who had baseline and at least one post-baseline ADHDRS-IV-Parent assessment.
Arm/Group Title Edivoxetine
Hide Arm/Group Description:
Edivoxetine: 0.1 mg/kg/day or participant specific known stable dose (rollover participants) up to 0.3 mg/kg/day, oral, daily for up to 5 years.
Overall Number of Participants Analyzed 264
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
Hyperactivity Impulsivity subscale Week 12 Number Analyzed 207 participants
-3.45  (0.33)
Hyperactivity Impulsivity subscale Week 60 Number Analyzed 102 participants
-4.27  (0.38)
Hyperactivity Impulsivity subscale Week 252 Number Analyzed 20 participants
-7.48  (0.46)
Inattention Score Week 12 Number Analyzed 207 participants
-3.91  (0.38)
Inattention Score Week 60 Number Analyzed 102 participants
-3.69  (0.45)
Inattention Score Week 252 Number Analyzed 20 participants
-5.59  (0.73)
Total Score Week 12 Number Analyzed 207 participants
-7.28  (0.65)
Total Score Week 60 Number Analyzed 102 participants
-7.83  (0.76)
Total Score Week 252 Number Analyzed 20 participants
-12.82  (1.06)
21.Secondary Outcome
Title Mean Change From Baseline of Total Score Clinical Global Impressions-Attention-Deficit/Hyperactivity Disorder-Severity (CGI-ADHD-S)
Hide Description The CGI-ADHD-S measures severity of the participants overall severity of ADHD symptoms. The score ranges from 1 to 7 (1=normal, not at all ill; 7=among the most extremely ill participants). LS mean change from baseline was adjusted for repeated measure analysis included baseline score and visit time in the model.
Time Frame Baseline, Week 12; Baseline, Week 60; Baseline, Week 252
Hide Outcome Measure Data
Hide Analysis Population Description
All enrolled participants who did not discontinue from the study for the reason 'Lost to follow up' at the first post-baseline observation and who had baseline and at least one post-baseline CGI-ADHD-S assessment.
Arm/Group Title Edivoxetine
Hide Arm/Group Description:
Edivoxetine: 0.1 mg/kg/day or participant specific known stable dose (rollover participants) up to 0.3 mg/kg/day, oral, daily for up to 5 years.
Overall Number of Participants Analyzed 264
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
Week 12 Number Analyzed 207 participants
-0.73  (0.07)
Week 60 Number Analyzed 103 participants
-0.85  (0.10)
Week 252 Number Analyzed 20 participants
-0.97  (0.17)
22.Secondary Outcome
Title Mean Change of Total Score Teacher-rated Swanson Nolan, and Pelham Rating Scale-Revised (SNAP-IV) ADHD Subscales (Hyperactive/Impulsive, Inattentive and Total Score)
Hide Description The SNAP-IV is a revision of the Swanson, Nolan, and Pelham (SNAP) Questionnaire (Swanson et al 1983). The SNAP-IV: ADHD Inattention Subscale (items 1-9) scores the intensity of each item during the last seven days on a 0 to 3 scale (0=not at all, 1=just a little, 2=pretty much, 3=very much). Possible scores range from 0-27. Lower scores indicate a lesser intensity of inattention and higher scores a greater intensity. The SNAP-IV ADHD Hyperactivity/Impulsivity Subscale (items 10-18) scores the intensity of each item in the last seven days on a 0 to 3 scale (0=not at all, 1=just a little, 2=pretty much, 3=very much). Possible scores range from 0-27. Lower scores indicate a lesser intensity of hyperactivity/impulsivity and higher scores, a greater intensity. SNAP-IV ADHD Combined Scale score (inattention + hyperactivity/impulsivity) ranges from 0-54. A low score of 0 indicates less inattention + hyperactivity/impulsivity. A high score of 54 indicates more inattention + hyperactivity.
Time Frame Baseline, Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
All enrolled participants with baseline and at least one post-baseline SNAP-IV assessment.
Arm/Group Title Edivoxetine
Hide Arm/Group Description:
Edivoxetine: 0.1 mg/kg/day or participant specific known stable dose (rollover participants) up to 0.3 mg/kg/day, oral, daily for up to 5 years.
Overall Number of Participants Analyzed 14
Mean (Standard Deviation)
Unit of Measure: units on a scale
Inattention Score 0.04  (0.42)
Hyperactivity/Impulsivity Score 0.05  (0.38)
Total Score 0.04  (0.32)
23.Secondary Outcome
Title Mean Change From Baseline of Total Score SNAP-IV Oppositional Defiant Disorder (ODD) Subscale
Hide Description The SNAP-IV ODD subscale includes items #21 to #28. Each item is scored on a 0 to 3 scale (0 = “Not At All”, 1 = “Just A Little”, 2 = “Pretty Much”, 3 = “Very Much”). Score ranges from 0-24. The lowest possible score is 0; highest is 24. Higher scores indicate a greater presence of ODD and lowers scores a lower presence of ODD.
Time Frame Baseline, Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
All enrolled participants with baseline and at least one post-baseline SNAP-IV assessment.
Arm/Group Title Edivoxetine
Hide Arm/Group Description:
Edivoxetine: 0.1 mg/kg/day or participant specific known stable dose (rollover participants) up to 0.3 mg/kg/day, oral, daily for up to 5 years.
Overall Number of Participants Analyzed 14
Mean (Standard Deviation)
Unit of Measure: units on a scale
0.02  (0.23)
24.Secondary Outcome
Title Mean Change From Baseline of Each Total Score Conners Comprehensive Behavior Rating Scales (CP-CBRS) Diagnostic and Statistical Manual of Mental Disorders, 4th Ed, Text Revision (DSM-IV-TR) for Symptom Subscales Manic Episode and Mixed Episode
Hide Description The Conners CBRS measures behaviors, emotions, and academic problems in children and adolescents. DSM-IV-TR symptom scales is included and assesses the following disorders: ADHD, conduct disorder, ODD, major depressive episode, manic episode, mixed episode, generalized anxiety disorder, separation anxiety disorder, social phobia, obsessive compulsive disorder, autistic disorder, and Asperger’s disorder. The age range suitable for this assessment is 6 to 18 years of age for parent form (203-item) and the teacher form (204-item) and 8 to18 years of age for the self-report form (179-item). The 203-item parent form of CP-CBRS was used in this study and completed by the parents/primary caregivers of the participants. Total score for each subscale is expressed as T-score based on gender/age norms: T-scores range from 0-100. Higher score indicates higher severity. Lower score indicate lower severity.
Time Frame Baseline, Week 60; Baseline, Week 252
Hide Outcome Measure Data
Hide Analysis Population Description
All enrolled participants who did not discontinue from the study for the reason 'Lost to follow up' at the first post-baseline observation and who had baseline and at least one post-baseline CP-CBRS assessment. No data was available for mixed episode due to not part of the statistical analysis plan..
Arm/Group Title Edivoxetine
Hide Arm/Group Description:
Edivoxetine: 0.1 mg/kg/day or participant specific known stable dose (rollover participants) up to 0.3 mg/kg/day, oral, daily for up to 5 years.
Overall Number of Participants Analyzed 264
Mean (Standard Deviation)
Unit of Measure: T-score
Manic Episode Week 60 Number Analyzed 102 participants
-7.09  (16.05)
Manic Episode Week 252 Number Analyzed 20 participants
-14.85  (16.04)
25.Secondary Outcome
Title Mean Change From Baseline of Each Total Score CP-CBRS (DSM-IV-TR) ADHD Symptom Subscales (Hyperactive/Impulsive and Inattentive)
Hide Description The Conners CBRS measures behaviors, emotions, and academic problems in children and adolescents. DSM-IV-TR symptom scales is included and assesses the following disorders: ADHD, conduct disorder, ODD, major depressive episode, manic episode, mixed episode, generalized anxiety disorder, separation anxiety disorder, social phobia, obsessive compulsive disorder, autistic disorder, and Asperger's disorder. The age range suitable for this assessment is 6 to 18 years of age for parent form (203-item) and the teacher form (204-item) and 8 to18 years of age for the self-report form (179-item). The 203-item parent form of CP-CBRS was used in this study and completed by the parents/primary caregivers of the participants. Total score for each subscale is expressed as T-score based on gender/age norms: T-scores range from 0-100. Higher score indicates higher severity. Lower score indicate lower severity.
Time Frame Baseline, Week 12; Baseline, Week 60; Baseline, Week 252
Hide Outcome Measure Data
Hide Analysis Population Description
All enrolled participants who did not discontinue from the study for the reason 'Lost to follow up' at the first post-baseline observation and who had baseline and at least one post-baseline CP-CBRS assessment.
Arm/Group Title Edivoxetine
Hide Arm/Group Description:
Edivoxetine: 0.1 mg/kg/day or participant specific known stable dose (rollover participants) up to 0.3 mg/kg/day, oral, daily for up to 5 years.
Overall Number of Participants Analyzed 264
Mean (Standard Deviation)
Unit of Measure: T Score
Inattentive Week 12 Number Analyzed 205 participants
-5.66  (13.44)
Inattentive Week 60 Number Analyzed 102 participants
-8.29  (14.59)
Inattentive Week 252 Number Analyzed 20 participants
-12.20  (13.32)
Hyperactivity/Impulsivity Week 12 Number Analyzed 205 participants
-6.33  (13.44)
Hyperactivity/Impulsivity Week 60 Number Analyzed 102 participants
-7.56  (14.65)
Hyperactivity/Impulsivity Week 252 Number Analyzed 20 participants
-13.80  (15.66)
26.Secondary Outcome
Title Mean Change From Baseline of Each Total Score CP-CBRS DSM-IV-TR for Oppositional Defiant Disorder (ODD), Anxiety, Conduct Disorder and Major Depressive Episode
Hide Description The Conners CBRS measures behaviors, emotions, and academic problems in children and adolescents. DSM-IV-TR symptom scales is included and assesses the following disorders: ADHD, conduct disorder, ODD, major depressive episode, manic episode, mixed episode, generalized anxiety disorder, separation anxiety disorder, social phobia, obsessive compulsive disorder, autistic disorder, and Asperger's disorder. The age range suitable for this assessment is 6 to 18 years of age for parent form (203-item) and the teacher form (204-item) and 8 to18 years of age for the self-report form (179-item). The 203-item parent form of CP-CBRS was used in this study and completed by the parents/primary caregivers of the participants. Total score for each subscale is expressed as T-score based on gender/age norms: T-scores range from 0-100. Higher score indicates higher severity. Lower score indicate lower severity.
Time Frame Baseline, Week 12; Baseline, Week 60; Baseline, Week 252
Hide Outcome Measure Data
Hide Analysis Population Description
All enrolled participants who did not discontinue from the study for the reason 'Lost to follow up' at the first post-baseline observation and who had baseline and at least one post-baseline CP-CBRS assessment.
Arm/Group Title Edivoxetine
Hide Arm/Group Description:
Edivoxetine: 0.1 mg/kg/day or participant specific known stable dose (rollover participants) up to 0.3 mg/kg/day, oral, daily for up to 5 years.
Overall Number of Participants Analyzed 264
Mean (Standard Deviation)
Unit of Measure: T-score
ODD Week 12 Number Analyzed 205 participants
-1.77  (11.17)
ODD Week 60 Number Analyzed 102 participants
-1.65  (15.03)
ODD Week 252 Number Analyzed 20 participants
-5.15  (9.41)
Anxiety Week 12 Number Analyzed 205 participants
-3.36  (11.84)
Anxiety Week 60 Number Analyzed 102 participants
-4.00  (15.71)
Anxiety Week 252 Number Analyzed 20 participants
-12.00  (12.03)
Conduct Disorder Week 12 Number Analyzed 205 participants
-2.12  (11.95)
Conduct Disorder Week 60 Number Analyzed 102 participants
-1.97  (14.35)
Conduct Disorder Week 252 Number Analyzed 20 participants
-2.65  (7.52)
Major Depressive Episode Week 12 Number Analyzed 205 participants
-3.31  (12.12)
Major Depressive Episode Week 60 Number Analyzed 102 participants
-3.43  (14.72)
Major Depressive Episode Week 252 Number Analyzed 20 participants
-9.05  (10.64)
27.Secondary Outcome
Title Mean Change From Baseline of Each Raw Score CP-CBRS Impairment Items Subscales for Schoolwork/Grades, Friendship/Relationships, and Home Life
Hide Description The Conners CBRS measures behaviors, emotions, and academic problems in children and adolescents. DSM-IV-TR symptom scales is included and assesses the following disorders: ADHD, conduct disorder, ODD, major depressive episode, manic episode, mixed episode, generalized anxiety disorder, separation anxiety disorder, social phobia, obsessive compulsive disorder, autistic disorder, and Asperger's disorder. The age range suitable for this assessment is 6 to 18 years of age for parent form (203-item) and the teacher form (204-item) and 8 to18 years of age for the self-report form (179-item). The 203-item parent form of CP-CBRS was used in this study and completed by the parents/primary caregivers of the participants. Schoolwork/grades, friendships/relationships, home life functioning scores range from 0=never to 3=very often. Raw scores are presented for each subscale with higher scores indicating higher severity and lower scores indicating lower severity.
Time Frame Baseline, Week 12; Baseline, Week 60; Baseline, Week 252
Hide Outcome Measure Data
Hide Analysis Population Description
All enrolled participants who did not discontinue from the study for the reason 'Lost to follow up' at the first post-baseline observation and who had baseline and at least one post-baseline CP-CBRS assessment.
Arm/Group Title Edivoxetine
Hide Arm/Group Description:
Edivoxetine: 0.1 mg/kg/day or participant specific known stable dose (rollover participants) up to 0.3 mg/kg/day, oral, daily for up to 5 years.
Overall Number of Participants Analyzed 264
Mean (Standard Deviation)
Unit of Measure: units on a scale
Schoolwork or Grades Week 12 Number Analyzed 205 participants
-0.35  (1.10)
Schoolwork or Grades Week 60 Number Analyzed 102 participants
-0.48  (1.17)
Schoolwork or Grades Week 252 Number Analyzed 20 participants
-0.65  (1.04)
Friendships and relationships Week 12 Number Analyzed 205 participants
-0.23  (0.91)
Friendships and relationships Week 60 Number Analyzed 102 participants
-0.26  (1.07)
Friendships and relationships Week 252 Number Analyzed 20 participants
-0.70  (0.98)
Home Life Week 12 Number Analyzed 205 participants
-0.30  (1.02)
Home Life Week 60 Number Analyzed 102 participants
-0.48  (1.12)
Home Life Week 252 Number Analyzed 20 participants
-0.80  (0.89)
28.Secondary Outcome
Title Mean Change From Baseline of Each Total Score CP-CBRS Content Subscale for Aggressive Behaviors, Academic Difficulties, Social Problems, and Violence Potential)
Hide Description CP-CBRS is a comprehensive assessment of a wide spectrum of behaviors, emotions, and academic problems in children and adolescents. It includes DSM-IV-TR symptom scales, empirical and rational scales, other clinical indicators and critical and impairment items. DSM-IV-TR symptom scales assess ADHD, conduct disorder, ODD, major depressive episode, manic episode, mixed episode, generalized anxiety disorder, separation anxiety disorder, social phobia, obsessive compulsive disorder, autistic disorder, and Asperger’s disorder. The age range is 6 to 18 years of age for parent form (203-item) and the teacher form (204-item) and 8 to18 years of age self-report form (179-item). The parent form of Conners CBRS (CP-CBRS) was used in this study and completed by the parents/primary caregivers of the participants. Total score for each subscale is expressed as T-score based on gender/age norms: T-scores range from 0-100. Higher score indicates higher severity. Lower score indicate lower severity
Time Frame Baseline, Week 12; Baseline, Week 60; Baseline, Week 252
Hide Outcome Measure Data
Hide Analysis Population Description
All enrolled participants who did not discontinue from the study for the reason 'Lost to follow up' at the first post-baseline observation and who had baseline and at least one post-baseline CP-CBRS assessment.
Arm/Group Title Edivoxetine
Hide Arm/Group Description:
Edivoxetine: 0.1 mg/kg/day or participant specific known stable dose (rollover participants) up to 0.3 mg/kg/day, oral, daily for up to 5 years.
Overall Number of Participants Analyzed 264
Mean (Standard Deviation)
Unit of Measure: T-score
Aggressive behaviors Week 12 Number Analyzed 205 participants
-1.53  (11.85)
Aggressive behaviors Week 60 Number Analyzed 102 participants
-0.80  (14.31)
Aggressive behaviors Week 252 Number Analyzed 20 participants
-5.65  (7.84)
Academic difficulties Week 12 Number Analyzed 205 participants
-4.39  (10.73)
Academic difficulties Week 60 Number Analyzed 102 participants
-4.37  (12.83)
Academic difficulties Week 252 Number Analyzed 20 participants
-8.55  (14.39)
Social problems Week 12 Number Analyzed 205 participants
-0.37  (12.21)
Social problems Week 60 Number Analyzed 102 participants
-1.12  (13.25)
Social problems Week 252 Number Analyzed 20 participants
-4.65  (13.83)
Violence Potential Week 12 Number Analyzed 205 participants
-1.25  (9.55)
Violence Potential Week 60 Number Analyzed 102 participants
-0.79  (10.72)
Violence Potential Week 252 Number Analyzed 20 participants
-3.70  (3.73)
29.Secondary Outcome
Title Mean Change From Baseline of the 5 Domain Scores Child Health and Illness Profile-Adolescent Edition (CHIP-AE) in 5 Health Outcome Domains (Satisfaction, Comfort, Resilience, Risk Avoidance and Achievement)
Hide Description CHIP-AE Child Report Form (CRF) is an adolescent rated assessment of their health status and level of functioning. The items in the 5 domains include: Achievement, Satisfaction, Comfort, Risk Avoidance, and Resilience. The majority of items assess frequency of activities or feelings using a 5-point response format (1=never, 5=always). Standard scores (T-scores) were established, with all domains and subdomains having a mean score of 50 and standard deviation of 10. Normative range is 40 to 60. Higher scores indicate better health and lower scores indicate worse health.
Time Frame Baseline, Week 12; Baseline, Week 60; Baseline, Week 156
Hide Outcome Measure Data
Hide Analysis Population Description
All enrolled participants who did not discontinue from the study for the reason 'Lost to follow up' at the first post-baseline observation and who had baseline and at least one post-baseline CHIP-AE assessment.
Arm/Group Title Edivoxetine
Hide Arm/Group Description:
Edivoxetine: 0.1 mg/kg/day or participant specific known stable dose (rollover participants) up to 0.3 mg/kg/day, oral, daily for up to 5 years.
Overall Number of Participants Analyzed 264
Mean (Standard Deviation)
Unit of Measure: T-score
Satisfaction Week 12 Number Analyzed 101 participants
1.81  (6.86)
Satisfaction Week 60 Number Analyzed 42 participants
1.01  (7.62)
Satisfaction Week 156 Number Analyzed 17 participants
3.29  (5.52)
Discomfort Week 12 Number Analyzed 100 participants
1.89  (4.88)
Discomfort Week 60 Number Analyzed 41 participants
0.07  (5.65)
Discomfort Week 156 Number Analyzed 16 participants
1.35  (7.29)
Resilience Week 12 Number Analyzed 100 participants
-1.20  (8.85)
Resilience Week 60 Number Analyzed 41 participants
-0.00  (8.69)
Resilience Week 156 Number Analyzed 17 participants
0.95  (8.26)
Risk Avoidance Week 12 Number Analyzed 100 participants
1.49  (6.26)
Risk Avoidance Week 60 Number Analyzed 42 participants
-2.04  (6.17)
Risk Avoidance Week 156 Number Analyzed 17 participants
-3.27  (5.81)
Achievement Week 12 Number Analyzed 12 participants
0.70  (5.86)
Achievement Week 60 Number Analyzed 4 participants
-2.35  (8.40)
Achievement Week 156 Number Analyzed 1 participants
7.33 [1]   (NA)
[1]
Standard deviation was not calculated due to n=1.
30.Secondary Outcome
Title Mean Change From Baseline of the 5 Domain Scores Child Health and Illness Profile-Child Edition (CHIP-CE) in 5 Health Outcome Domains (Satisfaction, Comfort, Resilience, Risk Avoidance and Achievement)
Hide Description CHIP-CE Parent Report Form (PRF) is a parent rated assessment of a child's health status/level of functioning. The achievement domain describes developmentally appropriate role functioning in school and with peers. The majority of items assess frequency of activities or feelings using a 5-point response format (1=never, 5=always). Standard scores (T-scores) were established, with all domains and subdomains having a mean score of 50 and standard deviation of 10. Normative range is 40 to 60. Higher scores indicate better health and lower scores indicate worse health.
Time Frame Baseline, Week 12; Baseline, Week 60; Baseline, Week 156
Hide Outcome Measure Data
Hide Analysis Population Description
All enrolled participants who did not discontinue from the study for the reason 'Lost to follow up' at the first post-baseline observation and who had baseline and at least one post-baseline CHIP-CE assessment.
Arm/Group Title Edivoxetine
Hide Arm/Group Description:
Edivoxetine: 0.1 mg/kg/day or participant specific known stable dose (rollover participants) up to 0.3 mg/kg/day, oral, daily for up to 5 years.
Overall Number of Participants Analyzed 264
Mean (Standard Deviation)
Unit of Measure: T-score
Satisfaction Week 12 Number Analyzed 95 participants
0.31  (8.65)
Satisfaction Week 60 Number Analyzed 48 participants
-1.87  (9.49)
Satisfaction Week 156 Number Analyzed 12 participants
-1.74  (5.34)
Discomfort Week 12 Number Analyzed 96 participants
-0.22  (8.43)
Discomfort Week 60 Number Analyzed 48 participants
-2.89  (12.11)
Discomfort Week 156 Number Analyzed 12 participants
-0.09  (9.37)
Resilience Week 12 Number Analyzed 95 participants
0.58  (10.93)
Resilience Week 60 Number Analyzed 48 participants
-1.07  (12.09)
Resilience Week 156 Number Analyzed 12 participants
0.83  (9.33)
Risk Avoidance and Achievement Week 12 Number Analyzed 96 participants
1.54  (8.10)
Risk Avoidance and Achievement Week 60 Number Analyzed 48 participants
1.89  (8.95)
Risk Avoidance and Achievement Week 156 Number Analyzed 12 participants
4.49  (13.89)
Achievement Week 12 Number Analyzed 96 participants
2.75  (9.01)
Achievement Week 60 Number Analyzed 48 participants
2.92  (10.58)
Achievement Week 156 Number Analyzed 12 participants
4.28  (9.54)
31.Secondary Outcome
Title Mean Change From Baseline of Total Score Euro-Qol Questionnaire - 5 Dimensions 3 Levels (EQ-5D-3L) Health State for Parent
Hide Description The EQ-5D-3L is a generic, multidimensional, health-related, quality-of-life (QoL) instrument that contains 2 parts: a health status profile and a visual analog scale to rate global health-related QoL. The profile allows respondents to rate their health state in 5 health dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has 3 levels of measure: no problems, some problems, and severe problems. The 5 dimensions of the health state profile are reported as a population-based (UK or US) health index score of theoretically possible health states ranging from 0-1; where 0 is death and 1 is perfect health. i.e., higher is better. Parents of the participants completed the EQ-5D-3L form for rating their own quality of life.
Time Frame Baseline, Week 12; Baseline, Week 60; Baseline, Week 252
Hide Outcome Measure Data
Hide Analysis Population Description
Parents of the participants completed the EQ-5D-3L form for rating their own quality of life, for parents of participants who did not discontinue from the study for the reason 'Lost to follow up' at the first post-baseline observation and who had baseline and at least one post-baseline EQ-5D-3L VAS assessment.
Arm/Group Title Edivoxetine
Hide Arm/Group Description:
Edivoxetine: 0.1 mg/kg/day or participant specific known stable dose (rollover participants) up to 0.3 mg/kg/day, oral, daily for up to 5 years.
Overall Number of Participants Analyzed 264
Mean (Standard Deviation)
Unit of Measure: units on a scale
UK population-based Week 12 Number Analyzed 129 participants
-0.011  (0.194)
UK population-based Week 60 Number Analyzed 64 participants
-0.016  (0.203)
UK population-based Week 252 Number Analyzed 15 participants
0.008  (0.087)
US population-based Week 12 Number Analyzed 129 participants
-0.009  (0.140)
US population-based Week 60 Number Analyzed 64 participants
-0.014  (0.144)
US population-based Week 252 Number Analyzed 15 participants
0.019  (0.077)
32.Secondary Outcome
Title Mean Change From Baseline of Total Score EQ-5D-3L Visual Analog Scale (VAS) for Parent
Hide Description The EQ-5D-3L is a generic, multidimensional, health-related, QoL instrument that contains 2 parts: a health status profile and a visual analog scale to rate global health-related QoL. The visual analog scale reported records the respondent's self-rated health state on a vertical line where the endpoints are labeled 100 being "best imaginable health state" and 0 being "worst imaginable health state." Parents of the participants complete EQ-5D-3L form for rating their own health.
Time Frame Baseline, Week 12; Baseline, Week 60; Baseline, Week 252
Hide Outcome Measure Data
Hide Analysis Population Description
Parents of the participants completed the EQ-5D-3L form for rating their own quality of life, for parents of participants who did not discontinue from the study for the reason 'Lost to follow up' at the first post-baseline observation and who had baseline and at least one post-baseline EQ-5D-3L VAS assessment.
Arm/Group Title Edivoxetine
Hide Arm/Group Description:
Edivoxetine: 0.1 mg/kg/day or participant specific known stable dose (rollover participants) up to 0.3 mg/kg/day, oral, daily for up to 5 years.
Overall Number of Participants Analyzed 264
Mean (Standard Deviation)
Unit of Measure: units on a scale
Week 12 Number Analyzed 129 participants
-0.845  (21.908)
Week 60 Number Analyzed 63 participants
2.968  (20.800)
Week 252 Number Analyzed 15 participants
2.467  (14.252)
33.Secondary Outcome
Title Mean Change of From Baseline Total Score EQ-5D-3L Health State for Child
Hide Description The EQ-5D-3L is a generic, multidimensional, health-related, QoL instrument that contains 2 parts: a health status profile and a visual analog scale to rate global health-related QoL. The profile allows respondents to rate their health state in 5 health dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has 3 levels of measure: no problems, some problems, and severe problems. The 5 dimensions of the health state profile are reported as a population-based (UK or US) health index score of theoretically possible health states ranging from 0-1; where 0 is death and 1 is perfect health. Parents of the participants aged 6 to 11 years completed the EQ-5D-3L form regarding the participants health-related quality of life. i.e., young children were unable to assess their own quality of life so the parents assessed the child's quality of life for them.
Time Frame Baseline, Week 12; Baseline, Week 60; Baseline, Week 252
Hide Outcome Measure Data
Hide Analysis Population Description
All enrolled participants who did not discontinue from the study for the reason 'Lost to follow up' at the first post-baseline observation and who had baseline and at least one post-baseline EQ-5D-3L assessment.
Arm/Group Title Edivoxetine
Hide Arm/Group Description:
Edivoxetine: 0.1 mg/kg/day or participant specific known stable dose (rollover participants) up to 0.3 mg/kg/day, oral, daily for up to 5 years.
Overall Number of Participants Analyzed 264
Mean (Standard Deviation)
Unit of Measure: units on a scale
UK population based Week 12 Number Analyzed 72 participants
0.024  (0.132)
UK population based Week 60 Number Analyzed 38 participants
0.010  (0.138)
UK population based Week 252 Number Analyzed 3 participants
0.000  (0.000)
US population based Week 12 Number Analyzed 72 participants
0.019  (0.109)
US population based Week 60 Number Analyzed 38 participants
0.006  (0.109)
US population based Week 252 Number Analyzed 3 participants
0.000  (0.000)
34.Secondary Outcome
Title Mean Change of From Baseline Total Score EQ-5D-3L VAS for Child
Hide Description EQ-5D-3L is a generic, multidimensional, health-related, QoL instrument that contains 2 parts: a health status profile and a visual analog scale to rate global health-related QoL. The visual analog scale reported records the respondent's self-rated health state on a vertical line where the endpoints are labeled 100 being "best imaginable health state" and 0 being "worst imaginable health state." Parents of the participants aged 6 to 11 years complete the EQ-5D-3L form for rating the participants health-related QoL, EQ-5D-3L. i.e., the young child was unable to assess their own quality of life then the parent assessed the child's quality of life.
Time Frame Baseline, Week 12; Baseline, Week 60; Baseline, Week 252
Hide Outcome Measure Data
Hide Analysis Population Description
All enrolled participants who did not discontinue from the study for the reason 'Lost to follow up' at the first post-baseline observation and who had baseline and at least one post-baseline EQ-5D-3L VAS assessment.
Arm/Group Title Edivoxetine
Hide Arm/Group Description:
Edivoxetine: 0.1 mg/kg/day or participant specific known stable dose (rollover participants) up to 0.3 mg/kg/day, oral, daily for up to 5 years.
Overall Number of Participants Analyzed 264
Mean (Standard Deviation)
Unit of Measure: units on a scale
Week 12 Number Analyzed 72 participants
-2.389  (21.636)
Week 60 Number Analyzed 38 participants
2.842  (15.023)
Week 252 Number Analyzed 3 participants
-1.667  (2.887)
35.Secondary Outcome
Title Mean Change From Baseline of Total Score EQ-5D-3L Health State for Adolescent
Hide Description EQ-5D-3L is a generic, multidimensional, health-related, QoL instrument that contains 2 parts: a health status profile and a visual analog scale to rate global health-related QoL. The profile allows respondents to rate their health state in 5 health dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has 3 levels of measure: no problems, some problems, and severe problems. The 5 dimensions of the health state profile are reported as a population-based (UK or US) health index score of theoretically possible health states ranging from 0-1; where 0 is death and 1 is perfect health. i.e., higher is better. Participants aged 12 years or older rate their own health-related quality of life using EQ-5D-3L.
Time Frame Baseline, Week 12; Baseline, Week 60; Baseline, Week 252
Hide Outcome Measure Data
Hide Analysis Population Description
All enrolled participants who did not discontinue from the study for the reason 'Lost to follow up' at the first post-baseline observation and who had baseline and at least one post-baseline EQ-5D-3L assessment.
Arm/Group Title Edivoxetine
Hide Arm/Group Description:
Edivoxetine: 0.1 mg/kg/day or participant specific known stable dose (rollover participants) up to 0.3 mg/kg/day, oral, daily for up to 5 years.
Overall Number of Participants Analyzed 264
Mean (Standard Deviation)
Unit of Measure: units on a scale
UK population based Week 12 Number Analyzed 106 participants
-0.010  (0.122)
UK population based Week 60 Number Analyzed 50 participants
-0.016  (0.217)
UK population based Week 252 Number Analyzed 10 participants
0.008  (0.055)
US population based Week 12 Number Analyzed 106 participants
-0.008  (0.101)
US population based Week 60 Number Analyzed 50 participants
-0.005  (0.150)
US population based Week 252 Number Analyzed 10 participants
0.013  (0.053)
36.Secondary Outcome
Title Mean Change From Baseline of Total Score EQ-5D-3L VAS
Hide Description EQ-5D-3L is a generic, multidimensional, health-related, QoL instrument that contains 2 parts: a health status profile and a visual analog scale to rate global health-related QoL. The visual analog scale reported records the respondent's self-rated health state on a vertical line where the endpoints are labeled 100 being "best imaginable health state" and 0 or being "worst imaginable health state." Participants aged 12 years or older rated their own health-related quality of life using the EQ-5D-3L VAS scale.
Time Frame Baseline, Week 12; Baseline, Week 60; Baseline, Week 252
Hide Outcome Measure Data
Hide Analysis Population Description
All enrolled participants who did not discontinue from the study for the reason 'Lost to follow up' at the first post-baseline observation and who had baseline and at least one post-baseline EQ-5D-3L VAS assessment.
Arm/Group Title Edivoxetine
Hide Arm/Group Description:
Edivoxetine: 0.1 mg/kg/day or participant specific known stable dose (rollover participants) up to 0.3 mg/kg/day, oral, daily for up to 5 years.
Overall Number of Participants Analyzed 264
Mean (Standard Deviation)
Unit of Measure: units on a scale
Week 12 Number Analyzed 107 participants
2.364  (21.224)
Week 60 Number Analyzed 50 participants
1.620  (18.025)
Week 252 Number Analyzed 10 participants
1.200  (12.007)
37.Secondary Outcome
Title Mean Change From Baseline of Total Score Woodcock Johnson III Test of Achievement ([WJ III ACH])
Hide Description The Woodcock Johnson (WJ III ACH) (Woodcock 2001) is designed to measure academic achievement and evaluates a person aged 2 to 90 years and the tool takes 60 to 160 minutes to complete depending on a person’s academic level. The WJ III ACH has 2 parallel forms (A and B) that can be administered in an alternating fashion. The WCJ III ACH uses standard scores (Deviation IQ) with an average standard score of 100 and a standard deviation of 15. Higher scores indicate better abilities/achievements. Lower scores indicate worse abilities/achievements.
Time Frame Baseline, Week 60
Hide Outcome Measure Data
Hide Analysis Population Description
All enrolled participants with baseline and at least one post-baseline WJ III ACH assessment.
Arm/Group Title Edivoxetine
Hide Arm/Group Description:
Edivoxetine: 0.1 mg/kg/day or participant specific known stable dose (rollover participants) up to 0.3 mg/kg/day, oral, daily for up to 5 years.
Overall Number of Participants Analyzed 20
Mean (Standard Deviation)
Unit of Measure: units on a scale
0.05  (5.01)
38.Secondary Outcome
Title Mean Change From Baseline of Total Score Wide Range Achievement Test (WRAT 4)
Hide Description The WRAT 4 is a norm-referenced test that measures the basic academic skills of word reading, sentence comprehension, spelling, and math computation. There are 2 alternate forms (Blue Form, Green Form) that can be used interchangeably with comparable results. It can be used to evaluate a person aged 5 to 94 years and the administration time is 30 to 45 minutes for children (8 years or older) and adults, and 15 to 25 minutes for young children (ages 5 to 7 years). The age-normed standard scores range from 55 – 145 and for each subtest/composite includes word reading, sentence comprehension, spelling, math computation and reading composite. Higher scores indicate better abilities/achievements. Lower scores indicate worse abilities/achievements.
Time Frame Baseline, Week 60
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Hide Analysis Population Description
All enrolled participants with baseline and at least one post-baseline WRAT 4 assessment.
Arm/Group Title Edivoxetine
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Edivoxetine: 0.1 mg/kg/day or participant specific known stable dose (rollover participants) up to 0.3 mg/kg/day, oral, daily for up to 5 years.
Overall Number of Participants Analyzed 10
Mean (Standard Deviation)
Unit of Measure: units on a scale
Word Reading -3.30  (25.84)
Sentence Comprehension -1.80  (25.94)
Spelling -6.40  (22.08)
Math Computation -8.50  (25.21)
Reading Composite 16.20  (36.10)
39.Secondary Outcome
Title Mean Change From Baseline of Total Score Wechsler Intelligence Scale for Children Fourth Edition (WISC-IV)
Hide Description The fourth edition of the WISC assessment (WISC-IV®) is administered to children ranging from 6 years to 16 years, 11 months. It contains 10 core subtests and 5 supplementary subtests, and takes 65-80 minutes to complete. In this study, Digit Span and Letter-Number Sequencing subtests were completed. Scaled scores range from 1 to 19. Higher scores denote better performance. Lower scores denote worse performance.
Time Frame Baseline, Week 60
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Hide Analysis Population Description
All enrolled participants with baseline and at least one post-baseline WISC-IV assessment.
Arm/Group Title Edivoxetine
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Edivoxetine: 0.1 mg/kg/day or participant specific known stable dose (rollover participants) up to 0.3 mg/kg/day, oral, daily for up to 5 years.
Overall Number of Participants Analyzed 72
Mean (Standard Deviation)
Unit of Measure: units on a scale
Digit Span Scaled Score 0.61  (2.42)
Letter-Number Sequencing Scaled Score 0.63  (2.53)
40.Secondary Outcome
Title Mean Change From Baseline of Total Score Wechsler Adult Intelligence Scale - Third Edition (WAIS-III)
Hide Description The WAIS-III® was used in the participants aged 17 years or older. Comprehensive reporting on the participant's intellectual ability is not required in this study. Raw scores for each of the 14 subtests are reported. Raw score ranges for each subtest are as follows: picture completion (0-25), vocabulary (0-66), digit symbol coding (0-133), similarities (0-33), block design (0-68), arithmetic (0-22), matrix reasoning (0-26), digit span forward and backward total (0-30), information (0-28), picture arrangement (0-22), comprehension (0-33), symbol search (0-60), letter-number sequencing (0-21), and object assembly (0-52). Higher scores reflect better performance and lower scores reflect lower performance.
Time Frame Baseline, Week 60
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Hide Analysis Population Description
All enrolled participants with baseline and at least one post-baseline WAIS-III assessment.
Arm/Group Title Edivoxetine
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Edivoxetine: 0.1 mg/kg/day or participant specific known stable dose (rollover participants) up to 0.3 mg/kg/day, oral, daily for up to 5 years.
Overall Number of Participants Analyzed 2
Mean (Standard Deviation)
Unit of Measure: units on a scale
Picture Completion 0.50  (0.71)
Vocabulary -11.50  (12.02)
Digit-Symbol Coding -22.00  (39.60)
Similarities 4.00  (7.07)
Block Design -8.00  (29.70)
Arithmetic 6.00  (9.90)
Matrix Reasoning 3.50  (2.12)
Digit Span 4.00  (2.83)
Information 3.50  (2.12)
Picture Arrangement -2.50  (0.71)
Comprehension -9.00  (11.31)
Symbol Search -5.00  (7.07)
Letter Number Sequencing 7.50  (12.02)
Object Assembly -10.00  (18.38)
Time Frame Overall edivoxetine treatment adverse event data were collected for up to 5 years.
Adverse Event Reporting Description 264 participants are the evaluable participants defined as enrolled participants who did not discontinue from the study for the reason 'Lost to follow up' at the first post-baseline observation.
 
Arm/Group Title Edivoxetine (Open-Label) Edivoxetine (Follow Up)
Hide Arm/Group Description Edivoxetine: 0.1 mg/kg/day or participant specific known stable dose (rollover participants) up to 0.3 mg/kg/day, oral, daily for up to 5 years. The follow up period is an optional taper of Edivoxetine. Treatment may be tapered or discontinued, over a period of 10 to 18 days.
All-Cause Mortality
Edivoxetine (Open-Label) Edivoxetine (Follow Up)
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Edivoxetine (Open-Label) Edivoxetine (Follow Up)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   7/264 (2.65%)      1/80 (1.25%)    
Infections and infestations     
Appendicitis  1  1/264 (0.38%)  1 0/80 (0.00%)  0
Dengue fever  1  1/264 (0.38%)  1 0/80 (0.00%)  0
Injury, poisoning and procedural complications     
Ankle fracture  1  1/264 (0.38%)  1 0/80 (0.00%)  0
Contusion  1  1/264 (0.38%)  1 0/80 (0.00%)  0
Intentional product misuse  1  1/264 (0.38%)  1 0/80 (0.00%)  0
Road traffic accident  1  1/264 (0.38%)  1 0/80 (0.00%)  0
Skin abrasion  1  1/264 (0.38%)  1 0/80 (0.00%)  0
Nervous system disorders     
Epilepsy  1  0/264 (0.00%)  0 1/80 (1.25%)  1
Psychiatric disorders     
Affective disorder  1  1/264 (0.38%)  1 0/80 (0.00%)  0
Suicidal ideation  1  1/264 (0.38%)  1 0/80 (0.00%)  0
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 18.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Edivoxetine (Open-Label) Edivoxetine (Follow Up)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   155/264 (58.71%)      5/80 (6.25%)    
Gastrointestinal disorders     
Abdominal pain upper  1  22/264 (8.33%)  28 2/80 (2.50%)  2
Nausea  1  35/264 (13.26%)  48 0/80 (0.00%)  0
Vomiting  1  45/264 (17.05%)  69 0/80 (0.00%)  0
General disorders     
Fatigue  1  16/264 (6.06%)  19 0/80 (0.00%)  0
Infections and infestations     
Gastroenteritis viral  1  15/264 (5.68%)  17 0/80 (0.00%)  0
Nasopharyngitis  1  18/264 (6.82%)  28 0/80 (0.00%)  0
Pharyngitis streptococcal  1  15/264 (5.68%)  19 0/80 (0.00%)  0
Upper respiratory tract infection  1  35/264 (13.26%)  44 2/80 (2.50%)  2
Metabolism and nutrition disorders     
Decreased appetite  1  15/264 (5.68%)  16 1/80 (1.25%)  1
Nervous system disorders     
Headache  1  45/264 (17.05%)  61 0/80 (0.00%)  0
Somnolence  1  14/264 (5.30%)  15 0/80 (0.00%)  0
Psychiatric disorders     
Irritability  1  22/264 (8.33%)  22 0/80 (0.00%)  0
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 18.0
Terminated due to low 5 year completer number and not meeting primary objective.
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.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Chief Medical Officer
Organization: Eli Lilly and Company
Phone: 800-545-5979
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Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT00965419     History of Changes
Other Study ID Numbers: 11332
H9P-MC-LNDH ( Other Identifier: Eli Lilly and Company )
First Submitted: August 24, 2009
First Posted: August 25, 2009
Results First Submitted: February 17, 2018
Results First Posted: April 27, 2018
Last Update Posted: April 27, 2018