A Study of Pediatric Participants With Attention Deficit/Hyperactivity Disorder

Number of Participants experienced at least one SAE during the study. A summary of other nonserious AEs, and all SAE's, regardless of causality, is located in the Reported Adverse Events section.

Time frame: Baseline Through Week 252

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 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.

Time frame: Baseline Through Week 252

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 SAE 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.

Time frame: Baseline, Week 12; Baseline, Week 60; Baseline, Week 252

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 CP-CBRS 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.

Time frame: Baseline, Week 12; Baseline, Week 60; Baseline, Week 252

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 ADHDRS-IV-Parent 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.

Time frame: Baseline, Week 60; Baseline, Week 252

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 CP-CBRS assessment. No data was available for mixed episode due to not part of the statistical analysis plan..

CP-CBRS is a comprehensive assessment of a wide spectrum of behaviors, emotions, and academic problems in children and adolescents. It includes DSM-IV-TR symptom scales, empirical and rational scales, other clinical indicators and critical and impairment items. DSM-IV-TR symptom scales assess ADHD, conduct disorder, ODD, major depressive episode, manic episode, mixed episode, generalized anxiety disorder, separation anxiety disorder, social phobia, obsessive compulsive disorder, autistic disorder, and Asperger's disorder. The age range is 6 to 18 years of age for parent form (203-item) and the teacher form (204-item) and 8 to18 years of age self-report form (179-item). The parent form of Conners CBRS (CP-CBRS) was used in this study and completed by the parents/primary caregivers of the participants. Total score for each subscale is expressed as T-score based on gender/age norms: T-scores range from 0-100. Higher score indicates higher severity. Lower score indicate lower severity

Time frame: Baseline, Week 12; Baseline, Week 60; Baseline, Week 252

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 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.

Time frame: Baseline, Week 12; Baseline, Week 60; Baseline, Week 252

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 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.

Time frame: Baseline, Week 12; Baseline, Week 60; Baseline, Week 252

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 CP-CBRS 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.

Time frame: Baseline, Week 12; Baseline, Week 60; Baseline, Week 156

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 CHIP-AE 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.

Time frame: Baseline, Week 12; Baseline, Week 60; Baseline, Week 156

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 CHIP-CE 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.

Time frame: Baseline, Week 12; Baseline, Week 60; Baseline, Week 252

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 CGI-ADHD-S 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.

Time frame: Baseline, Week 12; Baseline, Week 60; Baseline, Week 252

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 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 visual analog scale reported records the respondent's self-rated health state on a vertical line where the endpoints are labeled 100 being best imaginable health state and 0 or being worst imaginable health state. Participants aged 12 years or older rated their own health-related quality of life using the EQ-5D-3L VAS scale.

Time frame: Baseline, Week 12; Baseline, Week 60; Baseline, Week 252

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 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.

Time frame: Baseline, Week 12; Baseline, Week 60; Baseline, Week 252

Population: 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.

Time frame: Baseline, Week 12; Baseline, Week 60; Baseline, Week 252

Population: 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 SNAP-IV ODD subscale includes items #21 to #28. Each item is scored on a 0 to 3 scale (0 = Not At All, 1 = Just A Little, 2 = Pretty Much, 3 = Very Much). Score ranges from 0-24. The lowest possible score is 0; highest is 24. Higher scores indicate a greater presence of ODD and lowers scores a lower presence of ODD.

Time frame: Baseline, Week 12

Population: All enrolled participants with baseline and at least one post-baseline SNAP-IV 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.

Time frame: Baseline, Week 60

Population: All enrolled participants with baseline and at least one post-baseline WAIS-III 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.

Time frame: Baseline, Week 60

Population: All enrolled participants with baseline and at least one post-baseline WISC-IV 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.

Time frame: Baseline, Week 60

Population: All enrolled participants with baseline and at least one post-baseline WRAT 4 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.

Time frame: Baseline, Week 60

Population: All enrolled participants with baseline and at least one post-baseline WJ III ACH 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).

Time frame: Baseline, Week 60; Baseline, Week 240

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 Z-score assessment.

Time frame: Baseline, Week 60; Baseline, Week 240

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 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).

Time frame: Baseline, Week 60; Baseline, Week 240

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 Z-score 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.

Time frame: Baseline, Week 12; Baseline, Week 60; Baseline, Week 252

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 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 visual analog scale reported records the respondent's self-rated health state on a vertical line where the endpoints are labeled 100 being best imaginable health state and 0 being worst imaginable health state. Parents of the participants aged 6 to 11 years complete the EQ-5D-3L form for rating the participants health-related QoL, EQ-5D-3L. i.e., the young child was unable to assess their own quality of life then the parent assessed the child's quality of life.

Time frame: Baseline, Week 12; Baseline, Week 60; Baseline, Week 252

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 EQ-5D-3L VAS 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.

Time frame: Baseline, Week 12

Population: All enrolled participants with baseline and at least one post-baseline SNAP-IV 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.

Time frame: Baseline Up to Week 252

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 Tanners scale assessment.

Time frame: Baseline Through Week 252

Population: All enrolled participants who had evaluable discontinuation data.

Time frame: Week 12

Population: 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.

Time frame: Baseline Through Week 252

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 DCAE 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.

Time frame: Baseline Through Week 252

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 TEAE assessment.

Time frame: Week 60 through Week 252

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 tobacco, alcohol, and marijuana use 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.

Time frame: Baseline Up to Week 252

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 Tanners scale assessment.

Time frame: Baseline Through Week 252

Population: All enrolled participants who had evaluable discontinuation data.

Percentage of Participants in each category of CSSRS captures the occurrence, severity, and frequency of suicide-related thoughts and behaviors during the assessment period. Participants with suicidal ideation were those who had yes to any of the following questions: Wish to be dead, non-specific active suicidal thoughts, active suicidal ideation with any methods (not plan) without intent to act, active suicidal ideation with some intent to act, without specific plan, and active suicidal ideation with specific plan and intent. Suicidal behavior included those who had yes to any of the following questions: Preparatory acts or behavior, Aborted attempt, Interrupted attempt, Non-fatal suicide attempt, Completed suicide.

Time frame: Baseline Through Week 252, Baseline, 1-month (mo) Follow-Up (f/u)

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.

Time frame: Baseline Through Week 252

Population: All enrolled participants who did not discontinue from the study for the reason 'Lost to follow up' at the first post-baseline observation.

Time frame: Week 12

Population: 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.

Time frame: Week 60 through Week 252

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 tobacco, alcohol, and marijuana use 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.

Time frame: Baseline Through Week 252

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 TEAE assessment.

Time frame: Week 12

Population: 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.