Trial Outcomes & Findings for A Study of Pediatric Participants With Attention Deficit/Hyperactivity Disorder (NCT NCT00965419)
NCT ID: NCT00965419
Last Updated: 2019-10-08
Results Overview
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.
TERMINATED
PHASE2/PHASE3
267 participants
Baseline Through Week 252
2019-10-08
Participant Flow
All enrolled participants that received edivoxetine during the open-label treatment phase for up to 5 years and follow-up phase.
Participant milestones
| Measure |
Edivoxetine
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.
|
|---|---|
|
Open Label Treatment for Responders
STARTED
|
267
|
|
Open Label Treatment for Responders
Not Lost to f/u at First Post-baseline
|
264
|
|
Open Label Treatment for Responders
COMPLETED
|
20
|
|
Open Label Treatment for Responders
NOT COMPLETED
|
247
|
|
Follow-up Phase
STARTED
|
80
|
|
Follow-up Phase
COMPLETED
|
18
|
|
Follow-up Phase
NOT COMPLETED
|
62
|
Reasons for withdrawal
| Measure |
Edivoxetine
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.
|
|---|---|
|
Open Label Treatment for Responders
Adverse Event
|
33
|
|
Open Label Treatment for Responders
Entry Criteria Not Met
|
1
|
|
Open Label Treatment for Responders
Protocol Violation
|
21
|
|
Open Label Treatment for Responders
Withdrawal by Subject
|
27
|
|
Open Label Treatment for Responders
Physician Decision
|
6
|
|
Open Label Treatment for Responders
Sponsor Decision
|
5
|
|
Open Label Treatment for Responders
Parent/Caregiver Decision
|
41
|
|
Open Label Treatment for Responders
Lack of Efficacy
|
67
|
|
Open Label Treatment for Responders
Lost to Follow-up
|
46
|
|
Follow-up Phase
Adverse Event
|
9
|
|
Follow-up Phase
Protocol Violation
|
4
|
|
Follow-up Phase
Withdrawal by Subject
|
8
|
|
Follow-up Phase
Physician Decision
|
4
|
|
Follow-up Phase
Parent/Caregiver Decision
|
9
|
|
Follow-up Phase
Lack of Efficacy
|
28
|
Baseline Characteristics
A Study of Pediatric Participants With Attention Deficit/Hyperactivity Disorder
Baseline characteristics by cohort
| Measure |
All Participants
n=267 Participants
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.
|
|---|---|
|
Age, Continuous
|
11.64 years
STANDARD_DEVIATION 2.99 • n=5 Participants
|
|
Sex: Female, Male
Female
|
79 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
188 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
65 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
202 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
11 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
60 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
180 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
14 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
Canada
|
9 Participants
n=5 Participants
|
|
Region of Enrollment
Puerto Rico
|
11 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
235 Participants
n=5 Participants
|
|
Region of Enrollment
Taiwan
|
10 Participants
n=5 Participants
|
|
Region of Enrollment
Mexico
|
2 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline Through Week 252Population: 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.
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.
Outcome measures
| Measure |
Edivoxetine
n=264 Participants
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.
|
|---|---|
|
Percentage of Participants With At Least One Serious Adverse Events (SAE) Over the Duration of the Study
|
2.65 percentage of participants
|
PRIMARY outcome
Timeframe: Baseline Through Week 252Population: 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.
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.
Outcome measures
| Measure |
Edivoxetine
n=264 Participants
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.
|
|---|---|
|
Number of Participants With At Least One SAE
|
7 Participants
|
SECONDARY outcome
Timeframe: Baseline Through Week 252Population: 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.
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.
Outcome measures
| Measure |
Edivoxetine
n=264 Participants
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.
|
|---|---|
|
Percentage of Participants With Treatment-emergent Adverse Events (TEAEs)
|
76.89 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline Through Week 252Population: 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.
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.
Outcome measures
| Measure |
Edivoxetine
n=264 Participants
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.
|
|---|---|
|
Number of Participants With At Least One TEAE
|
203 Participants
|
SECONDARY outcome
Timeframe: Baseline Through Week 252Population: All enrolled participants who did not discontinue from the study for the reason 'Lost to follow up' at the first post-baseline observation.
Outcome measures
| Measure |
Edivoxetine
n=264 Participants
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.
|
|---|---|
|
Percentage of Participants With Discontinuation Due to Adverse Events (DCAEs)
|
12.50 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline Through Week 252Population: 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.
Outcome measures
| Measure |
Edivoxetine
n=264 Participants
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.
|
|---|---|
|
Number of Participants With At Least One DCAEs
|
33 Participants
|
SECONDARY outcome
Timeframe: Baseline Through Week 252Population: All enrolled participants who had evaluable discontinuation data.
Outcome measures
| Measure |
Edivoxetine
n=267 Participants
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.
|
|---|---|
|
Percentage of Participants Who Discontinued Due to Any Reason
|
92.51 Percentage of participants
|
SECONDARY outcome
Timeframe: Baseline Through Week 252Population: All enrolled participants who had evaluable discontinuation data.
Outcome measures
| Measure |
Edivoxetine
n=267 Participants
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.
|
|---|---|
|
Number of Participants Who Discontinued Due to Any Reason
|
247 Participants
|
SECONDARY outcome
Timeframe: Baseline Through Week 252, Baseline, 1-month (mo) Follow-Up (f/u)Population: 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.
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.
Outcome measures
| Measure |
Edivoxetine
n=264 Participants
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.
|
|---|---|
|
Percentage of Participants With Columbia-Suicide Severity Rating Scale (CSSRS) for Each Category
0-5 Years (Suicidal Ideation)
|
5.68 percentage of participants
|
|
Percentage of Participants With Columbia-Suicide Severity Rating Scale (CSSRS) for Each Category
0-5 Years (Suicidal Behavior)
|
0.00 percentage of participants
|
|
Percentage of Participants With Columbia-Suicide Severity Rating Scale (CSSRS) for Each Category
0-5 Yrs (Non-suicidal self-injurious)
|
0.38 percentage of participants
|
|
Percentage of Participants With Columbia-Suicide Severity Rating Scale (CSSRS) for Each Category
1 month f/u (Suicidal Ideation)
|
1.27 percentage of participants
|
|
Percentage of Participants With Columbia-Suicide Severity Rating Scale (CSSRS) for Each Category
1 month f/u (Suicidal Behavior)
|
0.00 percentage of participants
|
|
Percentage of Participants With Columbia-Suicide Severity Rating Scale (CSSRS) for Each Category
1 mo f/u (Non-suicidal self-injurious behavior)
|
0.00 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline, Week 60; Baseline, Week 240Population: 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.
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).
Outcome measures
| Measure |
Edivoxetine
n=264 Participants
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.
|
|---|---|
|
Mean Change From Baseline Z-scores for Height
Week 60
|
-0.05 Z-Score
Standard Deviation 0.36
|
|
Mean Change From Baseline Z-scores for Height
Week 240
|
-0.11 Z-Score
Standard Deviation 0.53
|
SECONDARY outcome
Timeframe: Baseline, Week 60; Baseline, Week 240Population: 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.
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).
Outcome measures
| Measure |
Edivoxetine
n=264 Participants
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.
|
|---|---|
|
Mean Change From Baseline Z-Score for Weight
Week 60
|
-0.17 Z-Score
Standard Deviation 0.37
|
|
Mean Change From Baseline Z-Score for Weight
Week 240
|
-0.25 Z-Score
Standard Deviation 0.77
|
SECONDARY outcome
Timeframe: Baseline, Week 60; Baseline, Week 240Population: 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.
Outcome measures
| Measure |
Edivoxetine
n=264 Participants
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.
|
|---|---|
|
Mean Change From Baseline Z-Score in Body Mass Index (BMI)
Week 60
|
-0.20 Z-Score
Standard Deviation 0.40
|
|
Mean Change From Baseline Z-Score in Body Mass Index (BMI)
Week 240
|
-0.32 Z-Score
Standard Deviation 0.83
|
SECONDARY outcome
Timeframe: Week 12Population: 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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Week 12Population: 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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Week 12Population: 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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline Up to Week 252Population: 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.
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.
Outcome measures
| Measure |
Edivoxetine
n=264 Participants
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.
|
|---|---|
|
Percentage of Participants in Sexual Maturation on Tanners Scale
Pubic Hair Male Tanner II
|
11.00 percentage of participants
|
|
Percentage of Participants in Sexual Maturation on Tanners Scale
Pubic Hair Male Tanner III
|
10.00 percentage of participants
|
|
Percentage of Participants in Sexual Maturation on Tanners Scale
Pubic Hair Male Tanner IV
|
23.00 percentage of participants
|
|
Percentage of Participants in Sexual Maturation on Tanners Scale
Pubic Hair Male Tanner V
|
31.00 percentage of participants
|
|
Percentage of Participants in Sexual Maturation on Tanners Scale
Pubic Hair Female Tanner I
|
12.50 percentage of participants
|
|
Percentage of Participants in Sexual Maturation on Tanners Scale
Pubic Hair Female Tanner II
|
14.58 percentage of participants
|
|
Percentage of Participants in Sexual Maturation on Tanners Scale
Pubic Hair Female Tanner III
|
6.25 percentage of participants
|
|
Percentage of Participants in Sexual Maturation on Tanners Scale
Pubic Hair Female Tanner IV
|
20.83 percentage of participants
|
|
Percentage of Participants in Sexual Maturation on Tanners Scale
Pubic Hair Female Tanner V
|
45.83 percentage of participants
|
|
Percentage of Participants in Sexual Maturation on Tanners Scale
Pubic Hair Male Tanner I
|
25.00 percentage of participants
|
|
Percentage of Participants in Sexual Maturation on Tanners Scale
Genital Development Male Tanner I
|
22.00 percentage of participants
|
|
Percentage of Participants in Sexual Maturation on Tanners Scale
Genital Development Male Tanner II
|
11.00 percentage of participants
|
|
Percentage of Participants in Sexual Maturation on Tanners Scale
Genital Development Male Tanner III
|
18.00 percentage of participants
|
|
Percentage of Participants in Sexual Maturation on Tanners Scale
Genital Development Male Tanner IV
|
17.00 percentage of participants
|
|
Percentage of Participants in Sexual Maturation on Tanners Scale
Genital Development Male Tanner V
|
32.00 percentage of participants
|
|
Percentage of Participants in Sexual Maturation on Tanners Scale
Breast Development Female Tanner I
|
16.67 percentage of participants
|
|
Percentage of Participants in Sexual Maturation on Tanners Scale
Breast Development Female Tanner II
|
6.25 percentage of participants
|
|
Percentage of Participants in Sexual Maturation on Tanners Scale
Breast Development Female Tanner III
|
16.67 percentage of participants
|
|
Percentage of Participants in Sexual Maturation on Tanners Scale
Breast Development Female Tanner IV
|
22.92 percentage of participants
|
|
Percentage of Participants in Sexual Maturation on Tanners Scale
Breast Development Female Tanner V
|
37.50 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline Up to Week 252Population: 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.
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.
Outcome measures
| Measure |
Edivoxetine
n=264 Participants
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.
|
|---|---|
|
Number of Participants in Sexual Maturation on Tanners Scale
Pubic Hair Female Tanner III
|
3 Participants
|
|
Number of Participants in Sexual Maturation on Tanners Scale
Pubic Hair Female Tanner IV
|
10 Participants
|
|
Number of Participants in Sexual Maturation on Tanners Scale
Pubic Hair Female Tanner V
|
22 Participants
|
|
Number of Participants in Sexual Maturation on Tanners Scale
Genital Development Male Tanner I
|
22 Participants
|
|
Number of Participants in Sexual Maturation on Tanners Scale
Genital Development Male Tanner II
|
11 Participants
|
|
Number of Participants in Sexual Maturation on Tanners Scale
Genital Development Male Tanner III
|
18 Participants
|
|
Number of Participants in Sexual Maturation on Tanners Scale
Genital Development Male Tanner IV
|
17 Participants
|
|
Number of Participants in Sexual Maturation on Tanners Scale
Genital Development Male Tanner V
|
32 Participants
|
|
Number of Participants in Sexual Maturation on Tanners Scale
Breast Development Female Tanner I
|
8 Participants
|
|
Number of Participants in Sexual Maturation on Tanners Scale
Breast Development Female Tanner II
|
3 Participants
|
|
Number of Participants in Sexual Maturation on Tanners Scale
Breast Development Female Tanner III
|
8 Participants
|
|
Number of Participants in Sexual Maturation on Tanners Scale
Breast Development Female Tanner IV
|
11 Participants
|
|
Number of Participants in Sexual Maturation on Tanners Scale
Breast Development Female Tanner V
|
18 Participants
|
|
Number of Participants in Sexual Maturation on Tanners Scale
Pubic Hair Male Tanner I
|
25 Participants
|
|
Number of Participants in Sexual Maturation on Tanners Scale
Pubic Hair Male Tanner II
|
11 Participants
|
|
Number of Participants in Sexual Maturation on Tanners Scale
Pubic Hair Male Tanner III
|
10 Participants
|
|
Number of Participants in Sexual Maturation on Tanners Scale
Pubic Hair Male Tanner IV
|
23 Participants
|
|
Number of Participants in Sexual Maturation on Tanners Scale
Pubic Hair Male Tanner V
|
31 Participants
|
|
Number of Participants in Sexual Maturation on Tanners Scale
Pubic Hair Female Tanner I
|
6 Participants
|
|
Number of Participants in Sexual Maturation on Tanners Scale
Pubic Hair Female Tanner II
|
7 Participants
|
SECONDARY outcome
Timeframe: Week 60 through Week 252Population: 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.
Outcome measures
| Measure |
Edivoxetine
n=264 Participants
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.
|
|---|---|
|
Percentage of Participants With Tobacco, Alcohol and Marijuana Use
Current Tobacco Use Week 60
|
0 percentage of participants
|
|
Percentage of Participants With Tobacco, Alcohol and Marijuana Use
Current Alcohol Use Week 60
|
0 percentage of participants
|
|
Percentage of Participants With Tobacco, Alcohol and Marijuana Use
Current Marijuana Use Week 60
|
0 percentage of participants
|
|
Percentage of Participants With Tobacco, Alcohol and Marijuana Use
Current Tobacco Use Week 252
|
0 percentage of participants
|
|
Percentage of Participants With Tobacco, Alcohol and Marijuana Use
Current Alcohol Use Week 252
|
0 percentage of participants
|
|
Percentage of Participants With Tobacco, Alcohol and Marijuana Use
Current Marijuana Use Week 252
|
0 percentage of participants
|
SECONDARY outcome
Timeframe: Week 60 through Week 252Population: 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.
Outcome measures
| Measure |
Edivoxetine
n=264 Participants
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.
|
|---|---|
|
Number of Participants With Tobacco, Alcohol and Marijuana Use
Current Tobacco Use Week 60
|
0 Participants
|
|
Number of Participants With Tobacco, Alcohol and Marijuana Use
Current Alcohol Use Week 60
|
0 Participants
|
|
Number of Participants With Tobacco, Alcohol and Marijuana Use
Current Marijuana Use Week 60
|
0 Participants
|
|
Number of Participants With Tobacco, Alcohol and Marijuana Use
Current Tobacco Use Week 252
|
0 Participants
|
|
Number of Participants With Tobacco, Alcohol and Marijuana Use
Current Alcohol Use 252
|
0 Participants
|
|
Number of Participants With Tobacco, Alcohol and Marijuana Use
Current Marijuana Use Week 252
|
0 Participants
|
SECONDARY outcome
Timeframe: Baseline, Week 12; Baseline, Week 60; Baseline, Week 252Population: 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.
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.
Outcome measures
| Measure |
Edivoxetine
n=264 Participants
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.
|
|---|---|
|
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)
Hyperactivity Impulsivity subscale Week 12
|
-3.45 units on a scale
Standard Error 0.33
|
|
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)
Hyperactivity Impulsivity subscale Week 60
|
-4.27 units on a scale
Standard Error 0.38
|
|
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)
Hyperactivity Impulsivity subscale Week 252
|
-7.48 units on a scale
Standard Error 0.46
|
|
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)
Inattention Score Week 12
|
-3.91 units on a scale
Standard Error 0.38
|
|
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)
Inattention Score Week 60
|
-3.69 units on a scale
Standard Error 0.45
|
|
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)
Inattention Score Week 252
|
-5.59 units on a scale
Standard Error 0.73
|
|
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)
Total Score Week 12
|
-7.28 units on a scale
Standard Error 0.65
|
|
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)
Total Score Week 60
|
-7.83 units on a scale
Standard Error 0.76
|
|
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)
Total Score Week 252
|
-12.82 units on a scale
Standard Error 1.06
|
SECONDARY outcome
Timeframe: Baseline, Week 12; Baseline, Week 60; Baseline, Week 252Population: 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.
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.
Outcome measures
| Measure |
Edivoxetine
n=264 Participants
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.
|
|---|---|
|
Mean Change From Baseline of Total Score Clinical Global Impressions-Attention-Deficit/Hyperactivity Disorder-Severity (CGI-ADHD-S)
Week 12
|
-0.73 units on a scale
Standard Error 0.07
|
|
Mean Change From Baseline of Total Score Clinical Global Impressions-Attention-Deficit/Hyperactivity Disorder-Severity (CGI-ADHD-S)
Week 60
|
-0.85 units on a scale
Standard Error 0.10
|
|
Mean Change From Baseline of Total Score Clinical Global Impressions-Attention-Deficit/Hyperactivity Disorder-Severity (CGI-ADHD-S)
Week 252
|
-0.97 units on a scale
Standard Error 0.17
|
SECONDARY outcome
Timeframe: Baseline, Week 12Population: All enrolled participants with baseline and at least one post-baseline SNAP-IV assessment.
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.
Outcome measures
| Measure |
Edivoxetine
n=14 Participants
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.
|
|---|---|
|
Mean Change of Total Score Teacher-rated Swanson Nolan, and Pelham Rating Scale-Revised (SNAP-IV) ADHD Subscales (Hyperactive/Impulsive, Inattentive and Total Score)
Inattention Score
|
0.04 units on a scale
Standard Deviation 0.42
|
|
Mean Change of Total Score Teacher-rated Swanson Nolan, and Pelham Rating Scale-Revised (SNAP-IV) ADHD Subscales (Hyperactive/Impulsive, Inattentive and Total Score)
Hyperactivity/Impulsivity Score
|
0.05 units on a scale
Standard Deviation 0.38
|
|
Mean Change of Total Score Teacher-rated Swanson Nolan, and Pelham Rating Scale-Revised (SNAP-IV) ADHD Subscales (Hyperactive/Impulsive, Inattentive and Total Score)
Total Score
|
0.04 units on a scale
Standard Deviation 0.32
|
SECONDARY outcome
Timeframe: Baseline, Week 12Population: All enrolled participants with baseline and at least one post-baseline SNAP-IV assessment.
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.
Outcome measures
| Measure |
Edivoxetine
n=14 Participants
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.
|
|---|---|
|
Mean Change From Baseline of Total Score SNAP-IV Oppositional Defiant Disorder (ODD) Subscale
|
0.02 units on a scale
Standard Deviation 0.23
|
SECONDARY outcome
Timeframe: Baseline, Week 60; Baseline, Week 252Population: 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..
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.
Outcome measures
| Measure |
Edivoxetine
n=264 Participants
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.
|
|---|---|
|
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
Manic Episode Week 60
|
-7.09 T-score
Standard Deviation 16.05
|
|
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
Manic Episode Week 252
|
-14.85 T-score
Standard Deviation 16.04
|
SECONDARY outcome
Timeframe: Baseline, Week 12; Baseline, Week 60; Baseline, Week 252Population: 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.
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.
Outcome measures
| Measure |
Edivoxetine
n=264 Participants
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.
|
|---|---|
|
Mean Change From Baseline of Each Total Score CP-CBRS (DSM-IV-TR) ADHD Symptom Subscales (Hyperactive/Impulsive and Inattentive)
Inattentive Week 12
|
-5.66 T Score
Standard Deviation 13.44
|
|
Mean Change From Baseline of Each Total Score CP-CBRS (DSM-IV-TR) ADHD Symptom Subscales (Hyperactive/Impulsive and Inattentive)
Inattentive Week 60
|
-8.29 T Score
Standard Deviation 14.59
|
|
Mean Change From Baseline of Each Total Score CP-CBRS (DSM-IV-TR) ADHD Symptom Subscales (Hyperactive/Impulsive and Inattentive)
Inattentive Week 252
|
-12.20 T Score
Standard Deviation 13.32
|
|
Mean Change From Baseline of Each Total Score CP-CBRS (DSM-IV-TR) ADHD Symptom Subscales (Hyperactive/Impulsive and Inattentive)
Hyperactivity/Impulsivity Week 12
|
-6.33 T Score
Standard Deviation 13.44
|
|
Mean Change From Baseline of Each Total Score CP-CBRS (DSM-IV-TR) ADHD Symptom Subscales (Hyperactive/Impulsive and Inattentive)
Hyperactivity/Impulsivity Week 60
|
-7.56 T Score
Standard Deviation 14.65
|
|
Mean Change From Baseline of Each Total Score CP-CBRS (DSM-IV-TR) ADHD Symptom Subscales (Hyperactive/Impulsive and Inattentive)
Hyperactivity/Impulsivity Week 252
|
-13.80 T Score
Standard Deviation 15.66
|
SECONDARY outcome
Timeframe: Baseline, Week 12; Baseline, Week 60; Baseline, Week 252Population: 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.
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.
Outcome measures
| Measure |
Edivoxetine
n=264 Participants
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.
|
|---|---|
|
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
ODD Week 12
|
-1.77 T-score
Standard Deviation 11.17
|
|
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
ODD Week 60
|
-1.65 T-score
Standard Deviation 15.03
|
|
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
ODD Week 252
|
-5.15 T-score
Standard Deviation 9.41
|
|
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
Anxiety Week 12
|
-3.36 T-score
Standard Deviation 11.84
|
|
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
Anxiety Week 60
|
-4.00 T-score
Standard Deviation 15.71
|
|
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
Anxiety Week 252
|
-12.00 T-score
Standard Deviation 12.03
|
|
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
Conduct Disorder Week 12
|
-2.12 T-score
Standard Deviation 11.95
|
|
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
Conduct Disorder Week 60
|
-1.97 T-score
Standard Deviation 14.35
|
|
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
Conduct Disorder Week 252
|
-2.65 T-score
Standard Deviation 7.52
|
|
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
Major Depressive Episode Week 12
|
-3.31 T-score
Standard Deviation 12.12
|
|
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
Major Depressive Episode Week 60
|
-3.43 T-score
Standard Deviation 14.72
|
|
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
Major Depressive Episode Week 252
|
-9.05 T-score
Standard Deviation 10.64
|
SECONDARY outcome
Timeframe: Baseline, Week 12; Baseline, Week 60; Baseline, Week 252Population: 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.
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.
Outcome measures
| Measure |
Edivoxetine
n=264 Participants
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.
|
|---|---|
|
Mean Change From Baseline of Each Raw Score CP-CBRS Impairment Items Subscales for Schoolwork/Grades, Friendship/Relationships, and Home Life
Schoolwork or Grades Week 12
|
-0.35 units on a scale
Standard Deviation 1.10
|
|
Mean Change From Baseline of Each Raw Score CP-CBRS Impairment Items Subscales for Schoolwork/Grades, Friendship/Relationships, and Home Life
Schoolwork or Grades Week 60
|
-0.48 units on a scale
Standard Deviation 1.17
|
|
Mean Change From Baseline of Each Raw Score CP-CBRS Impairment Items Subscales for Schoolwork/Grades, Friendship/Relationships, and Home Life
Schoolwork or Grades Week 252
|
-0.65 units on a scale
Standard Deviation 1.04
|
|
Mean Change From Baseline of Each Raw Score CP-CBRS Impairment Items Subscales for Schoolwork/Grades, Friendship/Relationships, and Home Life
Friendships and relationships Week 12
|
-0.23 units on a scale
Standard Deviation 0.91
|
|
Mean Change From Baseline of Each Raw Score CP-CBRS Impairment Items Subscales for Schoolwork/Grades, Friendship/Relationships, and Home Life
Friendships and relationships Week 60
|
-0.26 units on a scale
Standard Deviation 1.07
|
|
Mean Change From Baseline of Each Raw Score CP-CBRS Impairment Items Subscales for Schoolwork/Grades, Friendship/Relationships, and Home Life
Friendships and relationships Week 252
|
-0.70 units on a scale
Standard Deviation 0.98
|
|
Mean Change From Baseline of Each Raw Score CP-CBRS Impairment Items Subscales for Schoolwork/Grades, Friendship/Relationships, and Home Life
Home Life Week 12
|
-0.30 units on a scale
Standard Deviation 1.02
|
|
Mean Change From Baseline of Each Raw Score CP-CBRS Impairment Items Subscales for Schoolwork/Grades, Friendship/Relationships, and Home Life
Home Life Week 60
|
-0.48 units on a scale
Standard Deviation 1.12
|
|
Mean Change From Baseline of Each Raw Score CP-CBRS Impairment Items Subscales for Schoolwork/Grades, Friendship/Relationships, and Home Life
Home Life Week 252
|
-0.80 units on a scale
Standard Deviation 0.89
|
SECONDARY outcome
Timeframe: Baseline, Week 12; Baseline, Week 60; Baseline, Week 252Population: 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.
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
Outcome measures
| Measure |
Edivoxetine
n=264 Participants
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.
|
|---|---|
|
Mean Change From Baseline of Each Total Score CP-CBRS Content Subscale for Aggressive Behaviors, Academic Difficulties, Social Problems, and Violence Potential)
Aggressive behaviors Week 12
|
-1.53 T-score
Standard Deviation 11.85
|
|
Mean Change From Baseline of Each Total Score CP-CBRS Content Subscale for Aggressive Behaviors, Academic Difficulties, Social Problems, and Violence Potential)
Aggressive behaviors Week 60
|
-0.80 T-score
Standard Deviation 14.31
|
|
Mean Change From Baseline of Each Total Score CP-CBRS Content Subscale for Aggressive Behaviors, Academic Difficulties, Social Problems, and Violence Potential)
Aggressive behaviors Week 252
|
-5.65 T-score
Standard Deviation 7.84
|
|
Mean Change From Baseline of Each Total Score CP-CBRS Content Subscale for Aggressive Behaviors, Academic Difficulties, Social Problems, and Violence Potential)
Academic difficulties Week 12
|
-4.39 T-score
Standard Deviation 10.73
|
|
Mean Change From Baseline of Each Total Score CP-CBRS Content Subscale for Aggressive Behaviors, Academic Difficulties, Social Problems, and Violence Potential)
Academic difficulties Week 60
|
-4.37 T-score
Standard Deviation 12.83
|
|
Mean Change From Baseline of Each Total Score CP-CBRS Content Subscale for Aggressive Behaviors, Academic Difficulties, Social Problems, and Violence Potential)
Academic difficulties Week 252
|
-8.55 T-score
Standard Deviation 14.39
|
|
Mean Change From Baseline of Each Total Score CP-CBRS Content Subscale for Aggressive Behaviors, Academic Difficulties, Social Problems, and Violence Potential)
Social problems Week 12
|
-0.37 T-score
Standard Deviation 12.21
|
|
Mean Change From Baseline of Each Total Score CP-CBRS Content Subscale for Aggressive Behaviors, Academic Difficulties, Social Problems, and Violence Potential)
Social problems Week 60
|
-1.12 T-score
Standard Deviation 13.25
|
|
Mean Change From Baseline of Each Total Score CP-CBRS Content Subscale for Aggressive Behaviors, Academic Difficulties, Social Problems, and Violence Potential)
Social problems Week 252
|
-4.65 T-score
Standard Deviation 13.83
|
|
Mean Change From Baseline of Each Total Score CP-CBRS Content Subscale for Aggressive Behaviors, Academic Difficulties, Social Problems, and Violence Potential)
Violence Potential Week 12
|
-1.25 T-score
Standard Deviation 9.55
|
|
Mean Change From Baseline of Each Total Score CP-CBRS Content Subscale for Aggressive Behaviors, Academic Difficulties, Social Problems, and Violence Potential)
Violence Potential Week 60
|
-0.79 T-score
Standard Deviation 10.72
|
|
Mean Change From Baseline of Each Total Score CP-CBRS Content Subscale for Aggressive Behaviors, Academic Difficulties, Social Problems, and Violence Potential)
Violence Potential Week 252
|
-3.70 T-score
Standard Deviation 3.73
|
SECONDARY outcome
Timeframe: Baseline, Week 12; Baseline, Week 60; Baseline, Week 156Population: 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.
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.
Outcome measures
| Measure |
Edivoxetine
n=264 Participants
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.
|
|---|---|
|
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)
Satisfaction Week 12
|
1.81 T-score
Standard Deviation 6.86
|
|
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)
Satisfaction Week 60
|
1.01 T-score
Standard Deviation 7.62
|
|
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)
Satisfaction Week 156
|
3.29 T-score
Standard Deviation 5.52
|
|
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)
Discomfort Week 12
|
1.89 T-score
Standard Deviation 4.88
|
|
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)
Discomfort Week 60
|
0.07 T-score
Standard Deviation 5.65
|
|
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)
Discomfort Week 156
|
1.35 T-score
Standard Deviation 7.29
|
|
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)
Resilience Week 12
|
-1.20 T-score
Standard Deviation 8.85
|
|
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)
Resilience Week 60
|
-0.00 T-score
Standard Deviation 8.69
|
|
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)
Resilience Week 156
|
0.95 T-score
Standard Deviation 8.26
|
|
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)
Risk Avoidance Week 12
|
1.49 T-score
Standard Deviation 6.26
|
|
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)
Risk Avoidance Week 60
|
-2.04 T-score
Standard Deviation 6.17
|
|
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)
Risk Avoidance Week 156
|
-3.27 T-score
Standard Deviation 5.81
|
|
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)
Achievement Week 12
|
0.70 T-score
Standard Deviation 5.86
|
|
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)
Achievement Week 60
|
-2.35 T-score
Standard Deviation 8.40
|
|
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)
Achievement Week 156
|
7.33 T-score
Standard Deviation NA
Standard deviation was not calculated due to n=1.
|
SECONDARY outcome
Timeframe: Baseline, Week 12; Baseline, Week 60; Baseline, Week 156Population: 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.
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.
Outcome measures
| Measure |
Edivoxetine
n=264 Participants
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.
|
|---|---|
|
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)
Achievement Week 12
|
2.75 T-score
Standard Deviation 9.01
|
|
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)
Satisfaction Week 12
|
0.31 T-score
Standard Deviation 8.65
|
|
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)
Satisfaction Week 60
|
-1.87 T-score
Standard Deviation 9.49
|
|
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)
Satisfaction Week 156
|
-1.74 T-score
Standard Deviation 5.34
|
|
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)
Discomfort Week 12
|
-0.22 T-score
Standard Deviation 8.43
|
|
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)
Discomfort Week 60
|
-2.89 T-score
Standard Deviation 12.11
|
|
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)
Discomfort Week 156
|
-0.09 T-score
Standard Deviation 9.37
|
|
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)
Resilience Week 12
|
0.58 T-score
Standard Deviation 10.93
|
|
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)
Resilience Week 60
|
-1.07 T-score
Standard Deviation 12.09
|
|
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)
Resilience Week 156
|
0.83 T-score
Standard Deviation 9.33
|
|
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)
Risk Avoidance and Achievement Week 12
|
1.54 T-score
Standard Deviation 8.10
|
|
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)
Risk Avoidance and Achievement Week 60
|
1.89 T-score
Standard Deviation 8.95
|
|
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)
Risk Avoidance and Achievement Week 156
|
4.49 T-score
Standard Deviation 13.89
|
|
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)
Achievement Week 60
|
2.92 T-score
Standard Deviation 10.58
|
|
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)
Achievement Week 156
|
4.28 T-score
Standard Deviation 9.54
|
SECONDARY outcome
Timeframe: Baseline, Week 12; Baseline, Week 60; Baseline, Week 252Population: 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.
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.
Outcome measures
| Measure |
Edivoxetine
n=264 Participants
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.
|
|---|---|
|
Mean Change From Baseline of Total Score Euro-Qol Questionnaire - 5 Dimensions 3 Levels (EQ-5D-3L) Health State for Parent
UK population-based Week 12
|
-0.011 units on a scale
Standard Deviation 0.194
|
|
Mean Change From Baseline of Total Score Euro-Qol Questionnaire - 5 Dimensions 3 Levels (EQ-5D-3L) Health State for Parent
UK population-based Week 60
|
-0.016 units on a scale
Standard Deviation 0.203
|
|
Mean Change From Baseline of Total Score Euro-Qol Questionnaire - 5 Dimensions 3 Levels (EQ-5D-3L) Health State for Parent
UK population-based Week 252
|
0.008 units on a scale
Standard Deviation 0.087
|
|
Mean Change From Baseline of Total Score Euro-Qol Questionnaire - 5 Dimensions 3 Levels (EQ-5D-3L) Health State for Parent
US population-based Week 12
|
-0.009 units on a scale
Standard Deviation 0.140
|
|
Mean Change From Baseline of Total Score Euro-Qol Questionnaire - 5 Dimensions 3 Levels (EQ-5D-3L) Health State for Parent
US population-based Week 60
|
-0.014 units on a scale
Standard Deviation 0.144
|
|
Mean Change From Baseline of Total Score Euro-Qol Questionnaire - 5 Dimensions 3 Levels (EQ-5D-3L) Health State for Parent
US population-based Week 252
|
0.019 units on a scale
Standard Deviation 0.077
|
SECONDARY outcome
Timeframe: Baseline, Week 12; Baseline, Week 60; Baseline, Week 252Population: 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.
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.
Outcome measures
| Measure |
Edivoxetine
n=264 Participants
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.
|
|---|---|
|
Mean Change From Baseline of Total Score EQ-5D-3L Visual Analog Scale (VAS) for Parent
Week 12
|
-0.845 units on a scale
Standard Deviation 21.908
|
|
Mean Change From Baseline of Total Score EQ-5D-3L Visual Analog Scale (VAS) for Parent
Week 60
|
2.968 units on a scale
Standard Deviation 20.800
|
|
Mean Change From Baseline of Total Score EQ-5D-3L Visual Analog Scale (VAS) for Parent
Week 252
|
2.467 units on a scale
Standard Deviation 14.252
|
SECONDARY outcome
Timeframe: Baseline, Week 12; Baseline, Week 60; Baseline, Week 252Population: 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.
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.
Outcome measures
| Measure |
Edivoxetine
n=264 Participants
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.
|
|---|---|
|
Mean Change of From Baseline Total Score EQ-5D-3L Health State for Child
UK population based Week 12
|
0.024 units on a scale
Standard Deviation 0.132
|
|
Mean Change of From Baseline Total Score EQ-5D-3L Health State for Child
UK population based Week 60
|
0.010 units on a scale
Standard Deviation 0.138
|
|
Mean Change of From Baseline Total Score EQ-5D-3L Health State for Child
UK population based Week 252
|
0.000 units on a scale
Standard Deviation 0.000
|
|
Mean Change of From Baseline Total Score EQ-5D-3L Health State for Child
US population based Week 12
|
0.019 units on a scale
Standard Deviation 0.109
|
|
Mean Change of From Baseline Total Score EQ-5D-3L Health State for Child
US population based Week 60
|
0.006 units on a scale
Standard Deviation 0.109
|
|
Mean Change of From Baseline Total Score EQ-5D-3L Health State for Child
US population based Week 252
|
0.000 units on a scale
Standard Deviation 0.000
|
SECONDARY outcome
Timeframe: Baseline, Week 12; Baseline, Week 60; Baseline, Week 252Population: 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.
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.
Outcome measures
| Measure |
Edivoxetine
n=264 Participants
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.
|
|---|---|
|
Mean Change of From Baseline Total Score EQ-5D-3L VAS for Child
Week 12
|
-2.389 units on a scale
Standard Deviation 21.636
|
|
Mean Change of From Baseline Total Score EQ-5D-3L VAS for Child
Week 60
|
2.842 units on a scale
Standard Deviation 15.023
|
|
Mean Change of From Baseline Total Score EQ-5D-3L VAS for Child
Week 252
|
-1.667 units on a scale
Standard Deviation 2.887
|
SECONDARY outcome
Timeframe: Baseline, Week 12; Baseline, Week 60; Baseline, Week 252Population: 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.
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.
Outcome measures
| Measure |
Edivoxetine
n=264 Participants
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.
|
|---|---|
|
Mean Change From Baseline of Total Score EQ-5D-3L Health State for Adolescent
UK population based Week 12
|
-0.010 units on a scale
Standard Deviation 0.122
|
|
Mean Change From Baseline of Total Score EQ-5D-3L Health State for Adolescent
UK population based Week 60
|
-0.016 units on a scale
Standard Deviation 0.217
|
|
Mean Change From Baseline of Total Score EQ-5D-3L Health State for Adolescent
UK population based Week 252
|
0.008 units on a scale
Standard Deviation 0.055
|
|
Mean Change From Baseline of Total Score EQ-5D-3L Health State for Adolescent
US population based Week 12
|
-0.008 units on a scale
Standard Deviation 0.101
|
|
Mean Change From Baseline of Total Score EQ-5D-3L Health State for Adolescent
US population based Week 60
|
-0.005 units on a scale
Standard Deviation 0.150
|
|
Mean Change From Baseline of Total Score EQ-5D-3L Health State for Adolescent
US population based Week 252
|
0.013 units on a scale
Standard Deviation 0.053
|
SECONDARY outcome
Timeframe: Baseline, Week 12; Baseline, Week 60; Baseline, Week 252Population: 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.
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.
Outcome measures
| Measure |
Edivoxetine
n=264 Participants
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.
|
|---|---|
|
Mean Change From Baseline of Total Score EQ-5D-3L VAS
Week 12
|
2.364 units on a scale
Standard Deviation 21.224
|
|
Mean Change From Baseline of Total Score EQ-5D-3L VAS
Week 60
|
1.620 units on a scale
Standard Deviation 18.025
|
|
Mean Change From Baseline of Total Score EQ-5D-3L VAS
Week 252
|
1.200 units on a scale
Standard Deviation 12.007
|
SECONDARY outcome
Timeframe: Baseline, Week 60Population: All enrolled participants with baseline and at least one post-baseline WJ III ACH assessment.
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.
Outcome measures
| Measure |
Edivoxetine
n=20 Participants
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.
|
|---|---|
|
Mean Change From Baseline of Total Score Woodcock Johnson III Test of Achievement ([WJ III ACH])
|
0.05 units on a scale
Standard Deviation 5.01
|
SECONDARY outcome
Timeframe: Baseline, Week 60Population: All enrolled participants with baseline and at least one post-baseline WRAT 4 assessment.
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.
Outcome measures
| Measure |
Edivoxetine
n=10 Participants
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.
|
|---|---|
|
Mean Change From Baseline of Total Score Wide Range Achievement Test (WRAT 4)
Word Reading
|
-3.30 units on a scale
Standard Deviation 25.84
|
|
Mean Change From Baseline of Total Score Wide Range Achievement Test (WRAT 4)
Sentence Comprehension
|
-1.80 units on a scale
Standard Deviation 25.94
|
|
Mean Change From Baseline of Total Score Wide Range Achievement Test (WRAT 4)
Spelling
|
-6.40 units on a scale
Standard Deviation 22.08
|
|
Mean Change From Baseline of Total Score Wide Range Achievement Test (WRAT 4)
Math Computation
|
-8.50 units on a scale
Standard Deviation 25.21
|
|
Mean Change From Baseline of Total Score Wide Range Achievement Test (WRAT 4)
Reading Composite
|
16.20 units on a scale
Standard Deviation 36.10
|
SECONDARY outcome
Timeframe: Baseline, Week 60Population: All enrolled participants with baseline and at least one post-baseline WISC-IV assessment.
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.
Outcome measures
| Measure |
Edivoxetine
n=72 Participants
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.
|
|---|---|
|
Mean Change From Baseline of Total Score Wechsler Intelligence Scale for Children Fourth Edition (WISC-IV)
Digit Span Scaled Score
|
0.61 units on a scale
Standard Deviation 2.42
|
|
Mean Change From Baseline of Total Score Wechsler Intelligence Scale for Children Fourth Edition (WISC-IV)
Letter-Number Sequencing Scaled Score
|
0.63 units on a scale
Standard Deviation 2.53
|
SECONDARY outcome
Timeframe: Baseline, Week 60Population: All enrolled participants with baseline and at least one post-baseline WAIS-III assessment.
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.
Outcome measures
| Measure |
Edivoxetine
n=2 Participants
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.
|
|---|---|
|
Mean Change From Baseline of Total Score Wechsler Adult Intelligence Scale - Third Edition (WAIS-III)
Picture Completion
|
0.50 units on a scale
Standard Deviation 0.71
|
|
Mean Change From Baseline of Total Score Wechsler Adult Intelligence Scale - Third Edition (WAIS-III)
Vocabulary
|
-11.50 units on a scale
Standard Deviation 12.02
|
|
Mean Change From Baseline of Total Score Wechsler Adult Intelligence Scale - Third Edition (WAIS-III)
Digit-Symbol Coding
|
-22.00 units on a scale
Standard Deviation 39.60
|
|
Mean Change From Baseline of Total Score Wechsler Adult Intelligence Scale - Third Edition (WAIS-III)
Similarities
|
4.00 units on a scale
Standard Deviation 7.07
|
|
Mean Change From Baseline of Total Score Wechsler Adult Intelligence Scale - Third Edition (WAIS-III)
Block Design
|
-8.00 units on a scale
Standard Deviation 29.70
|
|
Mean Change From Baseline of Total Score Wechsler Adult Intelligence Scale - Third Edition (WAIS-III)
Arithmetic
|
6.00 units on a scale
Standard Deviation 9.90
|
|
Mean Change From Baseline of Total Score Wechsler Adult Intelligence Scale - Third Edition (WAIS-III)
Matrix Reasoning
|
3.50 units on a scale
Standard Deviation 2.12
|
|
Mean Change From Baseline of Total Score Wechsler Adult Intelligence Scale - Third Edition (WAIS-III)
Digit Span
|
4.00 units on a scale
Standard Deviation 2.83
|
|
Mean Change From Baseline of Total Score Wechsler Adult Intelligence Scale - Third Edition (WAIS-III)
Information
|
3.50 units on a scale
Standard Deviation 2.12
|
|
Mean Change From Baseline of Total Score Wechsler Adult Intelligence Scale - Third Edition (WAIS-III)
Picture Arrangement
|
-2.50 units on a scale
Standard Deviation 0.71
|
|
Mean Change From Baseline of Total Score Wechsler Adult Intelligence Scale - Third Edition (WAIS-III)
Comprehension
|
-9.00 units on a scale
Standard Deviation 11.31
|
|
Mean Change From Baseline of Total Score Wechsler Adult Intelligence Scale - Third Edition (WAIS-III)
Symbol Search
|
-5.00 units on a scale
Standard Deviation 7.07
|
|
Mean Change From Baseline of Total Score Wechsler Adult Intelligence Scale - Third Edition (WAIS-III)
Letter Number Sequencing
|
7.50 units on a scale
Standard Deviation 12.02
|
|
Mean Change From Baseline of Total Score Wechsler Adult Intelligence Scale - Third Edition (WAIS-III)
Object Assembly
|
-10.00 units on a scale
Standard Deviation 18.38
|
Adverse Events
Edivoxetine (Open-Label)
Edivoxetine (Follow Up)
Serious adverse events
| Measure |
Edivoxetine (Open-Label)
n=264 participants at risk
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.
|
Edivoxetine (Follow Up)
n=80 participants at risk
The follow up period is an optional taper of Edivoxetine. Treatment may be tapered or discontinued, over a period of 10 to 18 days.
|
|---|---|---|
|
Infections and infestations
Appendicitis
|
0.38%
1/264 • Number of events 1 • Overall edivoxetine treatment adverse event data were collected for up to 5 years.
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.
|
0.00%
0/80 • Overall edivoxetine treatment adverse event data were collected for up to 5 years.
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.
|
|
Infections and infestations
Dengue fever
|
0.38%
1/264 • Number of events 1 • Overall edivoxetine treatment adverse event data were collected for up to 5 years.
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.
|
0.00%
0/80 • Overall edivoxetine treatment adverse event data were collected for up to 5 years.
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.
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
0.38%
1/264 • Number of events 1 • Overall edivoxetine treatment adverse event data were collected for up to 5 years.
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.
|
0.00%
0/80 • Overall edivoxetine treatment adverse event data were collected for up to 5 years.
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.
|
|
Injury, poisoning and procedural complications
Contusion
|
0.38%
1/264 • Number of events 1 • Overall edivoxetine treatment adverse event data were collected for up to 5 years.
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.
|
0.00%
0/80 • Overall edivoxetine treatment adverse event data were collected for up to 5 years.
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.
|
|
Injury, poisoning and procedural complications
Intentional product misuse
|
0.38%
1/264 • Number of events 1 • Overall edivoxetine treatment adverse event data were collected for up to 5 years.
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.
|
0.00%
0/80 • Overall edivoxetine treatment adverse event data were collected for up to 5 years.
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.
|
|
Injury, poisoning and procedural complications
Road traffic accident
|
0.38%
1/264 • Number of events 1 • Overall edivoxetine treatment adverse event data were collected for up to 5 years.
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.
|
0.00%
0/80 • Overall edivoxetine treatment adverse event data were collected for up to 5 years.
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.
|
|
Injury, poisoning and procedural complications
Skin abrasion
|
0.38%
1/264 • Number of events 1 • Overall edivoxetine treatment adverse event data were collected for up to 5 years.
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.
|
0.00%
0/80 • Overall edivoxetine treatment adverse event data were collected for up to 5 years.
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.
|
|
Nervous system disorders
Epilepsy
|
0.00%
0/264 • Overall edivoxetine treatment adverse event data were collected for up to 5 years.
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.
|
1.2%
1/80 • Number of events 1 • Overall edivoxetine treatment adverse event data were collected for up to 5 years.
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.
|
|
Psychiatric disorders
Affective disorder
|
0.38%
1/264 • Number of events 1 • Overall edivoxetine treatment adverse event data were collected for up to 5 years.
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.
|
0.00%
0/80 • Overall edivoxetine treatment adverse event data were collected for up to 5 years.
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.
|
|
Psychiatric disorders
Suicidal ideation
|
0.38%
1/264 • Number of events 1 • Overall edivoxetine treatment adverse event data were collected for up to 5 years.
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.
|
0.00%
0/80 • Overall edivoxetine treatment adverse event data were collected for up to 5 years.
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.
|
Other adverse events
| Measure |
Edivoxetine (Open-Label)
n=264 participants at risk
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.
|
Edivoxetine (Follow Up)
n=80 participants at risk
The follow up period is an optional taper of Edivoxetine. Treatment may be tapered or discontinued, over a period of 10 to 18 days.
|
|---|---|---|
|
Gastrointestinal disorders
Abdominal pain upper
|
8.3%
22/264 • Number of events 28 • Overall edivoxetine treatment adverse event data were collected for up to 5 years.
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.
|
2.5%
2/80 • Number of events 2 • Overall edivoxetine treatment adverse event data were collected for up to 5 years.
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.
|
|
Gastrointestinal disorders
Nausea
|
13.3%
35/264 • Number of events 48 • Overall edivoxetine treatment adverse event data were collected for up to 5 years.
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.
|
0.00%
0/80 • Overall edivoxetine treatment adverse event data were collected for up to 5 years.
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.
|
|
Gastrointestinal disorders
Vomiting
|
17.0%
45/264 • Number of events 69 • Overall edivoxetine treatment adverse event data were collected for up to 5 years.
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.
|
0.00%
0/80 • Overall edivoxetine treatment adverse event data were collected for up to 5 years.
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.
|
|
General disorders
Fatigue
|
6.1%
16/264 • Number of events 19 • Overall edivoxetine treatment adverse event data were collected for up to 5 years.
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.
|
0.00%
0/80 • Overall edivoxetine treatment adverse event data were collected for up to 5 years.
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.
|
|
Infections and infestations
Gastroenteritis viral
|
5.7%
15/264 • Number of events 17 • Overall edivoxetine treatment adverse event data were collected for up to 5 years.
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.
|
0.00%
0/80 • Overall edivoxetine treatment adverse event data were collected for up to 5 years.
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.
|
|
Infections and infestations
Nasopharyngitis
|
6.8%
18/264 • Number of events 28 • Overall edivoxetine treatment adverse event data were collected for up to 5 years.
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.
|
0.00%
0/80 • Overall edivoxetine treatment adverse event data were collected for up to 5 years.
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.
|
|
Infections and infestations
Pharyngitis streptococcal
|
5.7%
15/264 • Number of events 19 • Overall edivoxetine treatment adverse event data were collected for up to 5 years.
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.
|
0.00%
0/80 • Overall edivoxetine treatment adverse event data were collected for up to 5 years.
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.
|
|
Infections and infestations
Upper respiratory tract infection
|
13.3%
35/264 • Number of events 44 • Overall edivoxetine treatment adverse event data were collected for up to 5 years.
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.
|
2.5%
2/80 • Number of events 2 • Overall edivoxetine treatment adverse event data were collected for up to 5 years.
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.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
5.7%
15/264 • Number of events 16 • Overall edivoxetine treatment adverse event data were collected for up to 5 years.
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.
|
1.2%
1/80 • Number of events 1 • Overall edivoxetine treatment adverse event data were collected for up to 5 years.
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.
|
|
Nervous system disorders
Headache
|
17.0%
45/264 • Number of events 61 • Overall edivoxetine treatment adverse event data were collected for up to 5 years.
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.
|
0.00%
0/80 • Overall edivoxetine treatment adverse event data were collected for up to 5 years.
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.
|
|
Nervous system disorders
Somnolence
|
5.3%
14/264 • Number of events 15 • Overall edivoxetine treatment adverse event data were collected for up to 5 years.
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.
|
0.00%
0/80 • Overall edivoxetine treatment adverse event data were collected for up to 5 years.
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.
|
|
Psychiatric disorders
Irritability
|
8.3%
22/264 • Number of events 22 • Overall edivoxetine treatment adverse event data were collected for up to 5 years.
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.
|
0.00%
0/80 • Overall edivoxetine treatment adverse event data were collected for up to 5 years.
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.
|
Additional Information
Chief Medical Officer
Eli Lilly and Company
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60