Attention Deficit Hyperactivity Disorder (ADHD)
Conditions
Keywords
ADHD
Brief summary
While the Lisdexamfetamine Dimesylate (SPD489) clinical program has studied the efficacy, safety, and tolerability of SPD489 in treating core symptoms of ADHD in children and adolescents aged 6-17 years and adults aged 18-55 years, the majority of these studies have been of short duration - up to 8 weeks. A number of long-term studies have been undertaken (up to 1 year) and these have confirmed the safety and ongoing efficacy in this patient population. In order to run a study with investigational medication within Poland the study changed to a Phase 3 rather than a Phase 4 study in that country. Please note that the study number remains as SPD489-404. Study SPD489-404 has been designed to further evaluate the long-term effects of SPD489 in children and adolescents over a 2-year treatment period.
Interventions
DRUGLisdexamfetamine dimesylate
Optimized dose of either 30, 50 or 70 mg capsule administered once daily for 2 years
Sponsors
Shire
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
6 Years to 17 Years
Healthy volunteers
No
Inclusion criteria
For subjects who participated in another SPD489 study (SPD489-317, SPD489-325, or SPD489 326): * Subject is a male or female aged 6-17 years. * Subject participated in SPD489-317, completed 9 weeks of treatment, and completed the 1 week post-treatment safety follow-up visit. For subjects who have not participated in another SPD489 study: * Subject is a male or female aged 6-17 years. * Subject must meet DSM-IV-TR criteria for a primary diagnosis of ADHD based on a detailed psychiatric evaluation. For all subjects: * Subject has a Baseline ADHD-RS-IV total score greater than or equal to 28. * Subject, who is female of childbearing potential (FOCP), must have a negative serum beta Human Chorionic Gonadotropin (HCG) pregnancy test, and a negative urine pregnancy test at Baseline, be non-lactating and agree to comply with any applicable contraceptive requirements of the protocol. * Subject and parent/LAR are willing and able to comply with all the testing and requirements defined, including oversight of morning dosing. Specifically, the parent/LAR must be available upon awakening, at approximately 7:00 AM, to dispense the dose of Investigational Product for the duration of the study. * Subject aged greater than or equal to 18 years has a systolic blood pressure less than or equal to 139 mmHg and a diastolic blood pressure less than or equal to 89 mmHg. * Subject is able to swallow a capsule.
Exclusion criteria
For subjects who participated in another SPD489 study (SPD489-317, SPD489-325, or SPD489 326): * Subject was terminated from a previous SPD489 study (SPD489-325 or SPD489 326) for protocol non-adherence and/or subject non-compliance and/or experienced a medication-related SAE or AE resulting in termination from the previous study. * Subject experienced any clinically significant AEs in a prior SPD489 study (SPD489 317, SPD489-325, or SPD489-326) that, in the opinion of the Investigator, would preclude further exposure to SPD489. For all subjects: * Subject's symptoms are well-controlled on their currently prescribed ADHD medication with acceptable tolerability. * Subject has a positive urine drug result at Screening. * Subject has a current, controlled (requiring a restricted medication) or uncontrolled, comorbid psychiatric diagnosis with significant symptoms such as any severe comorbid Axis II disorder or severe Axis I disorder (such as Post Traumatic Stress Disorder, psychosis, bipolar illness, pervasive developmental disorder, severe obsessive compulsive disorder, severe depressive or severe anxiety disorder) or other symptomatic manifestations, such as agitated states, marked anxiety, or tension. * Subject has taken another Investigational Product or taken part in a clinical study with the exception of a prior SPD489 study (SPD489-317, SPD489 325, or SPD489 326) within 30 days prior to Screening. * Subject weighs less than 22.7 kg (50 lbs). * Subject is significantly overweight. * Subject has a conduct disorder. Oppositional defiant disorder is not exclusionary. * Subject has a concurrent chronic or acute illness (such as severe allergic rhinitis or an infectious process requiring antibiotics), disability, or other condition that might confound the results of safety assessments conducted in the study or that might increase risk to the subject. * Subject is currently considered a suicide risk in the opinion of the Investigator, has previously made a suicide attempt, or has a prior history of, or is currently demonstrating active suicidal ideation. Subjects with intermittent passive suicidal ideation are not necessarily excluded based on the assessment of the Investigator * Subject has glaucoma. * Subject has current abnormal thyroid function, defined as abnormal thyroid stimulating hormone (TSH) and thyroxine (T4). Treatment with a stable dose of thyroid medication for at least 3 months is permitted. * Subject has any clinically significant ECG abnormality. * Subject has any clinically significant laboratory abnormalities. * Subject has a documented allergy, hypersensitivity, or intolerance to any active ingredient or excipients in SPD489. * Subject has a recent history (within the past 6 months) of suspected substance abuse or dependence disorder (excluding nicotine) in accordance with DSM-IV-TR criteria. * Subject has a history of seizures (other than infantile febrile seizures), a chronic or current tic disorder, a current diagnosis of Tourette's Disorder, or a known family history of Tourette's Disorder. Subject has a history of tics that is judged by the Investigator to be exclusionary. * Subject has a known history of symptomatic cardiovascular or cerebrovascular disease, advanced arteriosclerosis, structural cardiac abnormality, cardiomyopathy, serious heart rhythm abnormalities, coronary artery disease, or other serious cardiac problems that may place them at increased vulnerability to the sympathomimetic effects of a stimulant drug. * Subject has a known family history of sudden cardiac death or ventricular arrhythmia. * Subject has a medical condition, other than ADHD, that requires treatment with medications that have central nervous system effects and/or affect performance. Stable use of anticholinergic or theophylline bronchodilators is not exclusionary.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Brief Psychiatric Rating Scale for Children (BPRSC) Total Scores at Last On-treatment Assessment (LOTA) | Baseline (Week 0), LOTA (Week 104) | The BPRS-C that was designed to provide a characterization of the child and adolescent psychopathology, was used to monitor participant's safety. The BPRS-C assessed 7 independent factors (3 items each), for a total of 21 items that represented behavioural disorders, depression, thinking disturbance, psychomotor excitation, withdrawal retardation, anxiety, and organicity. Each item was rated using a 7-point scale including 0 (not present), 1 (very mild), 2 (mild), 3 (moderate), 4 (moderately severe), 5 (severe), and 6 (extremely severe). Total score is the sum of each item score; range from 0 to 126. Higher score indicated worse psychology. |
| Change From Baseline in Heart Rate at Last On-treatment Assessment (LOTA) | Baseline (Week 0), LOTA (Week 104) | — |
| Change From Baseline in QT Interval at Last On-treatment Assessment (LOTA) | Baseline (Week 0), LOTA (Week 104) | — |
| Change From Baseline in QT Interval Corrected Using Fridericia's Formula (QTcF) at Last On-treatment Assessment (LOTA) | Baseline (Week 0), LOTA (Week 104) | — |
| Number of Participants With All Treatment-Emergent Adverse Events (TEAEs) and Serious TEAEs | Baseline up to 3 days after the last dose of study treatment (up to 2 years) | An adverse event (AE) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. It included both serious and non-serious adverse event. A serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. AEs were defined as treatment-emergent if they started or worsened during the period between the day of a participant's first dose of investigational product in this study and the 3 days following cessation of treatment. |
| Change From Baseline in Pulse Rate at Last On-treatment Assessment (LOTA) | Baseline (Week 0), LOTA (Week 104) | — |
| Change From Baseline in Sitting Diastolic Blood Pressure (DBP) at Last On-treatment Assessment (LOTA) | Baseline (Week 0), LOTA (Week 104) | — |
| Change From Baseline in Sitting Systolic Blood Pressure (SBP) at Last On-treatment Assessment (LOTA) | Baseline (Week 0), LOTA (Week 104) | — |
| Change From Baseline in Body Weight at Last On-treatment Assessment (LOTA) | Baseline (Week 0), LOTA (Week 104) | — |
| Change From Baseline in Height at Last On-treatment Assessment (LOTA) | Baseline (Week 0), LOTA (Week 104) | — |
| Change From Baseline in Body Mass Index (BMI) at Last On-treatment Assessment (LOTA) | Baseline (Week 0), LOTA (Week 104) | BMI was calculated as (weight \[kilogram\] per height \[square meter\]). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Clinical Global Impression-Global Improvement (CGI-I) at Last On-treatment Assessment (LOTA) | LOTA (Week 104) | The Clinical Global Impressions (CGI) Scale permits a global evaluation of the participants' severity and improvement over time. This assessment will help guide the clinician on dosing adjustments. The CGI has been used extensively in clinical studies of ADHD. CGI-I was a 7-point scale ranging from 1 (very much improved) to 7 (very much worse), evaluated by the Investigator. |
| Number of Participants With Clinical Global Impression-Severity of Illness (CGI-S) at Last On-treatment Assessment (LOTA) | LOTA (Week 104) | The Clinical Global Impressions (CGI) Scale permits a global evaluation of the participants' severity and improvement over time. This assessment will help guide the clinician on dosing adjustments. The CGI has been used extensively in clinical studies of ADHD. CGI-S was a 7-point scale ranging from 1 (normal, not at all ill) to 7 (among the most extremely ill participants), evaluated by the Investigator. |
| Change From Baseline in the Attention-Deficit/Hyperactivity Disorder Rating Scale-IV (ADHD-RS-IV) Total Score at Last On-treatment Assessment (LOTA) | Baseline (Week 0), LOTA (Week 104) | ADHD-RS-IV consisted of 18 items designed to reflect current symptomatology of ADHD based on Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition - Text Revision (DSM-IV-TR) criteria, completed by the Investigator. Each item was scored from a range of 0 (reflecting no symptoms) to 3 (reflecting severe symptoms) with total scores ranging from 0-54. The 18 items were grouped into 2 sub-scales: hyperactivity/impulsivity (even number items 2-18 with score range of 0 to 27) and inattention (odd number items 1-17 with score range of 0 to 27). Higher scores depicted worse symptoms. |
Countries
Belgium, Germany, Hungary, Italy, Netherlands, Poland, Romania, Spain, Sweden, United Kingdom
Participant flow
Recruitment details
This study enrolled participants from 3 antecedent studies (SPD489-317 \[NCT01106430\], SPD489-325 \[NCT00763971\], and SPD489-326 \[NCT00784654\]), or directly enrolled.
Pre-assignment details
If participants from previous SDP489 studies had a gap of more than 7 days before participation in this study, they were required to have baseline Attention-Deficit/Hyperactivity Disorder (ADHD) total score of at least 28, to be enrolled. Of 348 participants screened, 314 participants were enrolled and treated.
Participants by arm
| Arm | Count |
|---|---|
| Lisdexamfetamine Dimesylate Lisdexamfetamine dimesylate (SPD489) 30, 50 and 70 mg capsules once daily orally during the 4-week dose optimization period and the 100-week maintenance period. | 314 |
| Total | 314 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 39 |
| Overall Study | Lack of Efficacy | 5 |
| Overall Study | Lost to Follow-up | 5 |
| Overall Study | Other | 29 |
| Overall Study | Protocol Violation | 4 |
| Overall Study | Withdrawal by Subject | 41 |
Baseline characteristics
| Characteristic | Lisdexamfetamine Dimesylate |
|---|---|
| ADHD-RS-IV: Hyperactivity/Impulsivity Subscore | 19 scores on a scale STANDARD_DEVIATION 5.86 |
| ADHD-RS-IV: Inattention Subscale Score | 22.1 scores on a scale STANDARD_DEVIATION 3.52 |
| Age, Continuous | 11.4 years STANDARD_DEVIATION 2.88 |
| Attention-Deficit/Hyperactivity Disorder Rating Scale-IV (ADHD-RS-IV): Total Score | 41.1 scores on a scale STANDARD_DEVIATION 7.03 |
| Body Mass Index (BMI) | 19.22 kilogram per square meter STANDARD_DEVIATION 3.389 |
| Body Weight | 46.13 kilogram(s) STANDARD_DEVIATION 16.434 |
| Clinical Global Impressions - Severity of Illness (CGI-S) Rating Among the most extremely ill participants | 11 Participants |
| Clinical Global Impressions - Severity of Illness (CGI-S) Rating Borderline mentally ill | 0 Participants |
| Clinical Global Impressions - Severity of Illness (CGI-S) Rating Markedly ill | 152 Participants |
| Clinical Global Impressions - Severity of Illness (CGI-S) Rating Mildly ill | 1 Participants |
| Clinical Global Impressions - Severity of Illness (CGI-S) Rating Moderately ill | 69 Participants |
| Clinical Global Impressions - Severity of Illness (CGI-S) Rating Normal, not all ill | 0 Participants |
| Clinical Global Impressions - Severity of Illness (CGI-S) Rating Severely ill | 81 Participants |
| Height | 152.29 centimeters STANDARD_DEVIATION 16.633 |
| Sex: Female, Male Female | 64 Participants |
| Sex: Female, Male Male | 250 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 250 / 314 |
| serious Total, serious adverse events | 28 / 314 |
Outcome results
Primary
Change From Baseline in Body Mass Index (BMI) at Last On-treatment Assessment (LOTA)
BMI was calculated as (weight \[kilogram\] per height \[square meter\]).
Time frame: Baseline (Week 0), LOTA (Week 104)
Population: Safety population with participants evaluable for this outcome
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Lisdexamfetamine Dimesylate | Change From Baseline in Body Mass Index (BMI) at Last On-treatment Assessment (LOTA) | -0.5 kilogram per square meter | Standard Deviation 1.72 |
Primary
Change From Baseline in Body Weight at Last On-treatment Assessment (LOTA)
Time frame: Baseline (Week 0), LOTA (Week 104)
Population: Safety population with participants evaluable for this outcome
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Lisdexamfetamine Dimesylate | Change From Baseline in Body Weight at Last On-treatment Assessment (LOTA) | 2.1 kilogram(s) | Standard Deviation 5.83 |
Primary
Change From Baseline in Brief Psychiatric Rating Scale for Children (BPRSC) Total Scores at Last On-treatment Assessment (LOTA)
The BPRS-C that was designed to provide a characterization of the child and adolescent psychopathology, was used to monitor participant's safety. The BPRS-C assessed 7 independent factors (3 items each), for a total of 21 items that represented behavioural disorders, depression, thinking disturbance, psychomotor excitation, withdrawal retardation, anxiety, and organicity. Each item was rated using a 7-point scale including 0 (not present), 1 (very mild), 2 (mild), 3 (moderate), 4 (moderately severe), 5 (severe), and 6 (extremely severe). Total score is the sum of each item score; range from 0 to 126. Higher score indicated worse psychology.
Time frame: Baseline (Week 0), LOTA (Week 104)
Population: Safety population with participants evaluable for this outcome
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Lisdexamfetamine Dimesylate | Change From Baseline in Brief Psychiatric Rating Scale for Children (BPRSC) Total Scores at Last On-treatment Assessment (LOTA) | -10.3 scores on a scale | Standard Deviation 9.64 |
Primary
Change From Baseline in Heart Rate at Last On-treatment Assessment (LOTA)
Time frame: Baseline (Week 0), LOTA (Week 104)
Population: Safety population with participants evaluable for this outcome
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Lisdexamfetamine Dimesylate | Change From Baseline in Heart Rate at Last On-treatment Assessment (LOTA) | 7.1 beats per minute | Standard Deviation 13.51 |
Primary
Change From Baseline in Height at Last On-treatment Assessment (LOTA)
Time frame: Baseline (Week 0), LOTA (Week 104)
Population: Safety population with participants evaluable for this outcome
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Lisdexamfetamine Dimesylate | Change From Baseline in Height at Last On-treatment Assessment (LOTA) | 6.1 centimeter(s) | Standard Deviation 4.9 |
Primary
Change From Baseline in Pulse Rate at Last On-treatment Assessment (LOTA)
Time frame: Baseline (Week 0), LOTA (Week 104)
Population: Safety population with participants evaluable for this outcome
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Lisdexamfetamine Dimesylate | Change From Baseline in Pulse Rate at Last On-treatment Assessment (LOTA) | 7 beats per minute | Standard Deviation 11.6 |
Primary
Change From Baseline in QT Interval at Last On-treatment Assessment (LOTA)
Time frame: Baseline (Week 0), LOTA (Week 104)
Population: Safety population with participants evaluable for this outcome
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Lisdexamfetamine Dimesylate | Change From Baseline in QT Interval at Last On-treatment Assessment (LOTA) | -10.3 milliseconds | Standard Deviation 23.53 |
Primary
Change From Baseline in QT Interval Corrected Using Fridericia's Formula (QTcF) at Last On-treatment Assessment (LOTA)
Time frame: Baseline (Week 0), LOTA (Week 104)
Population: Safety population with participants evaluable for this outcome
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Lisdexamfetamine Dimesylate | Change From Baseline in QT Interval Corrected Using Fridericia's Formula (QTcF) at Last On-treatment Assessment (LOTA) | -0.6 milliseconds | Standard Deviation 15.24 |
Primary
Change From Baseline in Sitting Diastolic Blood Pressure (DBP) at Last On-treatment Assessment (LOTA)
Time frame: Baseline (Week 0), LOTA (Week 104)
Population: Safety population with participants evaluable for this outcome
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Lisdexamfetamine Dimesylate | Change From Baseline in Sitting Diastolic Blood Pressure (DBP) at Last On-treatment Assessment (LOTA) | 3.2 mmHg | Standard Deviation 9.05 |
Primary
Change From Baseline in Sitting Systolic Blood Pressure (SBP) at Last On-treatment Assessment (LOTA)
Time frame: Baseline (Week 0), LOTA (Week 104)
Population: Safety population with participants evaluable for this outcome
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Lisdexamfetamine Dimesylate | Change From Baseline in Sitting Systolic Blood Pressure (SBP) at Last On-treatment Assessment (LOTA) | 3.4 mmHg | Standard Deviation 10.33 |
Primary
Number of Participants With All Treatment-Emergent Adverse Events (TEAEs) and Serious TEAEs
An adverse event (AE) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. It included both serious and non-serious adverse event. A serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. AEs were defined as treatment-emergent if they started or worsened during the period between the day of a participant's first dose of investigational product in this study and the 3 days following cessation of treatment.
Time frame: Baseline up to 3 days after the last dose of study treatment (up to 2 years)
Population: Safety population included all participants who took at least 1 dose of Lisdexamfetamine dimesylate during this study.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Lisdexamfetamine Dimesylate | Number of Participants With All Treatment-Emergent Adverse Events (TEAEs) and Serious TEAEs | Any TEAE | 282 participants |
| Lisdexamfetamine Dimesylate | Number of Participants With All Treatment-Emergent Adverse Events (TEAEs) and Serious TEAEs | Serious TEAE | 28 participants |
Secondary
Change From Baseline in the Attention-Deficit/Hyperactivity Disorder Rating Scale-IV (ADHD-RS-IV) Total Score at Last On-treatment Assessment (LOTA)
ADHD-RS-IV consisted of 18 items designed to reflect current symptomatology of ADHD based on Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition - Text Revision (DSM-IV-TR) criteria, completed by the Investigator. Each item was scored from a range of 0 (reflecting no symptoms) to 3 (reflecting severe symptoms) with total scores ranging from 0-54. The 18 items were grouped into 2 sub-scales: hyperactivity/impulsivity (even number items 2-18 with score range of 0 to 27) and inattention (odd number items 1-17 with score range of 0 to 27). Higher scores depicted worse symptoms.
Time frame: Baseline (Week 0), LOTA (Week 104)
Population: Full Analysis Set (FAS) population included all participants who took at least 1 dose of SPD489 and had at least 1 on-treatment post baseline efficacy assessment.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Lisdexamfetamine Dimesylate | Change From Baseline in the Attention-Deficit/Hyperactivity Disorder Rating Scale-IV (ADHD-RS-IV) Total Score at Last On-treatment Assessment (LOTA) | -25.8 Scores on a scale | Standard Deviation 11.1 |
Comparison: Change from baseline to LOTA value was assessed for differences from zero using a 2-sided, 1 sample t-test at a 0.05 significance level.p-value: <0.001t-test, 2 sided
Secondary
Number of Participants With Clinical Global Impression-Global Improvement (CGI-I) at Last On-treatment Assessment (LOTA)
The Clinical Global Impressions (CGI) Scale permits a global evaluation of the participants' severity and improvement over time. This assessment will help guide the clinician on dosing adjustments. The CGI has been used extensively in clinical studies of ADHD. CGI-I was a 7-point scale ranging from 1 (very much improved) to 7 (very much worse), evaluated by the Investigator.
Time frame: LOTA (Week 104)
Population: FAS population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Lisdexamfetamine Dimesylate | Number of Participants With Clinical Global Impression-Global Improvement (CGI-I) at Last On-treatment Assessment (LOTA) | Very much improved | 141 participants |
| Lisdexamfetamine Dimesylate | Number of Participants With Clinical Global Impression-Global Improvement (CGI-I) at Last On-treatment Assessment (LOTA) | Much improved | 92 participants |
| Lisdexamfetamine Dimesylate | Number of Participants With Clinical Global Impression-Global Improvement (CGI-I) at Last On-treatment Assessment (LOTA) | Minimally improved | 28 participants |
| Lisdexamfetamine Dimesylate | Number of Participants With Clinical Global Impression-Global Improvement (CGI-I) at Last On-treatment Assessment (LOTA) | No change | 20 participants |
| Lisdexamfetamine Dimesylate | Number of Participants With Clinical Global Impression-Global Improvement (CGI-I) at Last On-treatment Assessment (LOTA) | Minimally worse | 13 participants |
| Lisdexamfetamine Dimesylate | Number of Participants With Clinical Global Impression-Global Improvement (CGI-I) at Last On-treatment Assessment (LOTA) | Much worse | 5 participants |
| Lisdexamfetamine Dimesylate | Number of Participants With Clinical Global Impression-Global Improvement (CGI-I) at Last On-treatment Assessment (LOTA) | Very much worse | 0 participants |
Secondary
Number of Participants With Clinical Global Impression-Severity of Illness (CGI-S) at Last On-treatment Assessment (LOTA)
The Clinical Global Impressions (CGI) Scale permits a global evaluation of the participants' severity and improvement over time. This assessment will help guide the clinician on dosing adjustments. The CGI has been used extensively in clinical studies of ADHD. CGI-S was a 7-point scale ranging from 1 (normal, not at all ill) to 7 (among the most extremely ill participants), evaluated by the Investigator.
Time frame: LOTA (Week 104)
Population: FAS population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Lisdexamfetamine Dimesylate | Number of Participants With Clinical Global Impression-Severity of Illness (CGI-S) at Last On-treatment Assessment (LOTA) | Normal, not all ill | 73 participants |
| Lisdexamfetamine Dimesylate | Number of Participants With Clinical Global Impression-Severity of Illness (CGI-S) at Last On-treatment Assessment (LOTA) | Borderline mentally ill | 97 participants |
| Lisdexamfetamine Dimesylate | Number of Participants With Clinical Global Impression-Severity of Illness (CGI-S) at Last On-treatment Assessment (LOTA) | Mildly ill | 67 participants |
| Lisdexamfetamine Dimesylate | Number of Participants With Clinical Global Impression-Severity of Illness (CGI-S) at Last On-treatment Assessment (LOTA) | Moderately ill | 39 participants |
| Lisdexamfetamine Dimesylate | Number of Participants With Clinical Global Impression-Severity of Illness (CGI-S) at Last On-treatment Assessment (LOTA) | Markedly ill | 17 participants |
| Lisdexamfetamine Dimesylate | Number of Participants With Clinical Global Impression-Severity of Illness (CGI-S) at Last On-treatment Assessment (LOTA) | Severely ill | 4 participants |
| Lisdexamfetamine Dimesylate | Number of Participants With Clinical Global Impression-Severity of Illness (CGI-S) at Last On-treatment Assessment (LOTA) | Among the most extremely ill participants | 2 participants |