Schizophrenia
Conditions
Keywords
Schizophrenia
Brief summary
This is a multiple ascending dose study; the purpose of this study is to examine the safety, tolerability and pharmacokinetics (levels of drug in the blood) of SPD489 in Schizophrenic Patients who are currently maintained on a stable dose of an antipsychotic medication.
Interventions
SPD489 administered orally in ascending doses (50mg, 70mg, 100mg, 150mg, 200mg, 250mg). Each of these doses will be administered once daily for 5 days. Total number of days dosed is 30 days.
DRUGPlacebo
Placebo Capsule(s) for oral use taken once daily for 30 days
Sponsors
Shire
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
Subjects must be diagnosed with schizophrenia, on a stable dose of an antipsychotic and not have any cardiac risk factors
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Systolic Blood Pressure at Day 5: 50 mg | Baseline and day 5 | Blood pressure and pulse measurements were taken using an automated blood pressure monitoring device (ideally using the same device, the same arm and in the same position throughout the study). Measurements of vital signs were performed in triplicate (3 measurements) after the subject had been in a sitting position for at least 5 minutes. Each of the 3 triplicate readings were performed in succession, at least 1-2 minutes apart, with the cuff fully deflated between measurements. It was expected that the triplicate measurements be obtained within a 5-6 minute period. |
| Change From Baseline in Systolic Blood Pressure at Day 5: 70 mg | Baseline and day 5 | Blood pressure and pulse measurements were taken using an automated blood pressure monitoring device (ideally using the same device, the same arm and in the same position throughout the study). Measurements of vital signs were performed in triplicate (3 measurements) after the subject had been in a sitting position for at least 5 minutes. Each of the 3 triplicate readings were performed in succession, at least 1-2 minutes apart, with the cuff fully deflated between measurements. It was expected that the triplicate measurements be obtained within a 5-6 minute period. |
| Change From Baseline in Systolic Blood Pressure at Day 5: 100 mg | Baseline and day 5 | Blood pressure and pulse measurements were taken using an automated blood pressure monitoring device (ideally using the same device, the same arm and in the same position throughout the study). Measurements of vital signs were performed in triplicate (3 measurements) after the subject had been in a sitting position for at least 5 minutes. Each of the 3 triplicate readings were performed in succession, at least 1-2 minutes apart, with the cuff fully deflated between measurements. It was expected that the triplicate measurements be obtained within a 5-6 minute period. |
| Change From Baseline in Systolic Blood Pressure at Day 5: 150 mg | Baseline and day 5 | Blood pressure and pulse measurements were taken using an automated blood pressure monitoring device (ideally using the same device, the same arm and in the same position throughout the study). Measurements of vital signs were performed in triplicate (3 measurements) after the subject had been in a sitting position for at least 5 minutes. Each of the 3 triplicate readings were performed in succession, at least 1-2 minutes apart, with the cuff fully deflated between measurements. It was expected that the triplicate measurements be obtained within a 5-6 minute period. |
| Change From Baseline in Systolic Blood Pressure at Day 5: 200 mg | Baseline and day 5 | Blood pressure and pulse measurements were taken using an automated blood pressure monitoring device (ideally using the same device, the same arm and in the same position throughout the study). Measurements of vital signs were performed in triplicate (3 measurements) after the subject had been in a sitting position for at least 5 minutes. Each of the 3 triplicate readings were performed in succession, at least 1-2 minutes apart, with the cuff fully deflated between measurements. It was expected that the triplicate measurements be obtained within a 5-6 minute period. |
| Change From Baseline in Systolic Blood Pressure at Day 5: 250 mg | Baseline and day 5 | Blood pressure and pulse measurements were taken using an automated blood pressure monitoring device (ideally using the same device, the same arm and in the same position throughout the study). Measurements of vital signs were performed in triplicate (3 measurements) after the subject had been in a sitting position for at least 5 minutes. Each of the 3 triplicate readings were performed in succession, at least 1-2 minutes apart, with the cuff fully deflated between measurements. It was expected that the triplicate measurements be obtained within a 5-6 minute period. |
| Change From Baseline in Diastolic Blood Pressure at Day 5: 50 mg | Baseline and day 5 | Blood pressure and pulse measurements were taken using an automated blood pressure monitoring device (ideally using the same device, the same arm and in the same position throughout the study). Measurements of vital signs were performed in triplicate (3 measurements) after the subject had been in a sitting position for at least 5 minutes. Each of the 3 triplicate readings were performed in succession, at least 1-2 minutes apart, with the cuff fully deflated between measurements. It was expected that the triplicate measurements be obtained within a 5-6 minute period. |
| Change From Baseline in Diastolic Blood Pressure at Day 5: 70 mg | Baseline and day 5 | Blood pressure and pulse measurements were taken using an automated blood pressure monitoring device (ideally using the same device, the same arm and in the same position throughout the study). Measurements of vital signs were performed in triplicate (3 measurements) after the subject had been in a sitting position for at least 5 minutes. Each of the 3 triplicate readings were performed in succession, at least 1-2 minutes apart, with the cuff fully deflated between measurements. It was expected that the triplicate measurements be obtained within a 5-6 minute period. |
| Change From Baseline in Diastolic Blood Pressure at Day 5: 100 mg | Baseline and day 5 | Blood pressure and pulse measurements were taken using an automated blood pressure monitoring device (ideally using the same device, the same arm and in the same position throughout the study). Measurements of vital signs were performed in triplicate (3 measurements) after the subject had been in a sitting position for at least 5 minutes. Each of the 3 triplicate readings were performed in succession, at least 1-2 minutes apart, with the cuff fully deflated between measurements. It was expected that the triplicate measurements be obtained within a 5-6 minute period. |
| Change From Baseline in Diastolic Blood Pressure at Day 5: 150 mg | Baseline and day 5 | Blood pressure and pulse measurements were taken using an automated blood pressure monitoring device (ideally using the same device, the same arm and in the same position throughout the study). Measurements of vital signs were performed in triplicate (3 measurements) after the subject had been in a sitting position for at least 5 minutes. Each of the 3 triplicate readings were performed in succession, at least 1-2 minutes apart, with the cuff fully deflated between measurements. It was expected that the triplicate measurements be obtained within a 5-6 minute period. |
| Change From Baseline in Diastolic Blood Pressure at Day 5: 200 mg | Baseline and day 5 | Blood pressure and pulse measurements were taken using an automated blood pressure monitoring device (ideally using the same device, the same arm and in the same position throughout the study). Measurements of vital signs were performed in triplicate (3 measurements) after the subject had been in a sitting position for at least 5 minutes. Each of the 3 triplicate readings were performed in succession, at least 1-2 minutes apart, with the cuff fully deflated between measurements. It was expected that the triplicate measurements be obtained within a 5-6 minute period. |
| Change From Baseline in Diastolic Blood Pressure at Day 5: 250 mg | Baseline and day 5 | Blood pressure and pulse measurements were taken using an automated blood pressure monitoring device (ideally using the same device, the same arm and in the same position throughout the study). Measurements of vital signs were performed in triplicate (3 measurements) after the subject had been in a sitting position for at least 5 minutes. Each of the 3 triplicate readings were performed in succession, at least 1-2 minutes apart, with the cuff fully deflated between measurements. It was expected that the triplicate measurements be obtained within a 5-6 minute period. |
| Change From Baseline in Pulse Rate at Day 5: 50 mg | Baseline and day 5 | Blood pressure and pulse measurements were taken using an automated blood pressure monitoring device (ideally using the same device, the same arm and in the same position throughout the study). Measurements of vital signs were performed in triplicate (3 measurements) after the subject had been in a sitting position for at least 5 minutes. Each of the 3 triplicate readings were performed in succession, at least 1-2 minutes apart, with the cuff fully deflated between measurements. It was expected that the triplicate measurements be obtained within a 5-6 minute period. |
| Change From Baseline in Pulse Rate at Day 5: 70 mg | Baseline and day 5 | Blood pressure and pulse measurements were taken using an automated blood pressure monitoring device (ideally using the same device, the same arm and in the same position throughout the study). Measurements of vital signs were performed in triplicate (3 measurements) after the subject had been in a sitting position for at least 5 minutes. Each of the 3 triplicate readings were performed in succession, at least 1-2 minutes apart, with the cuff fully deflated between measurements. It was expected that the triplicate measurements be obtained within a 5-6 minute period. |
| Change From Baseline in Pulse Rate at Day 5: 100 mg | Baseline and day 5 | Blood pressure and pulse measurements were taken using an automated blood pressure monitoring device (ideally using the same device, the same arm and in the same position throughout the study). Measurements of vital signs were performed in triplicate (3 measurements) after the subject had been in a sitting position for at least 5 minutes. Each of the 3 triplicate readings were performed in succession, at least 1-2 minutes apart, with the cuff fully deflated between measurements. It was expected that the triplicate measurements be obtained within a 5-6 minute period. |
| Change From Baseline in Pulse Rate at Day 5: 150 mg | Baseline and day 5 | Blood pressure and pulse measurements were taken using an automated blood pressure monitoring device (ideally using the same device, the same arm and in the same position throughout the study). Measurements of vital signs were performed in triplicate (3 measurements) after the subject had been in a sitting position for at least 5 minutes. Each of the 3 triplicate readings were performed in succession, at least 1-2 minutes apart, with the cuff fully deflated between measurements. It was expected that the triplicate measurements be obtained within a 5-6 minute period. |
| Change From Baseline in Pulse Rate at Day 5: 200 mg | Baseline and day 5 | Blood pressure and pulse measurements were taken using an automated blood pressure monitoring device (ideally using the same device, the same arm and in the same position throughout the study). Measurements of vital signs were performed in triplicate (3 measurements) after the subject had been in a sitting position for at least 5 minutes. Each of the 3 triplicate readings were performed in succession, at least 1-2 minutes apart, with the cuff fully deflated between measurements. It was expected that the triplicate measurements be obtained within a 5-6 minute period. |
| Change From Baseline in Pulse Rate at Day 5: 250 mg | Baseline and day 5 | Blood pressure and pulse measurements were taken using an automated blood pressure monitoring device (ideally using the same device, the same arm and in the same position throughout the study). Measurements of vital signs were performed in triplicate (3 measurements) after the subject had been in a sitting position for at least 5 minutes. Each of the 3 triplicate readings were performed in succession, at least 1-2 minutes apart, with the cuff fully deflated between measurements. It was expected that the triplicate measurements be obtained within a 5-6 minute period. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Scale for the Assessment of Negative Symptoms (SANS-18) Total Score at Day 5: 50 mg | Baseline and Day 5 | The SANS was modified by eliminating the global and attention items; the score of the remaining non-global items is referred to as the SANS-18 total score. Each of the 18-items is scored on a scale from 0 (not at all) to 5 (severe) with a total scoring range of 0 to 90. Higher scores indicate more impairment. |
| Change From Baseline in Scale for the Assessment of Negative Symptoms (SANS-18) Total Score at Day 5: 70 mg | Baseline and Day 5 | The SANS was modified by eliminating the global and attention items; the score of the remaining non-global items is referred to as the SANS-18 total score. Each of the 18-items is scored on a scale from 0 (not at all) to 5 (severe) with a total scoring range of 0 to 90. Higher scores indicate more impairment. |
| Change From Baseline in Scale for the Assessment of Negative Symptoms (SANS-18) Total Score at Day 5: 100 mg | Baseline and Day 5 | The SANS was modified by eliminating the global and attention items; the score of the remaining non-global items is referred to as the SANS-18 total score. Each of the 18-items is scored on a scale from 0 (not at all) to 5 (severe) with a total scoring range of 0 to 90. Higher scores indicate more impairment. |
| Change From Baseline in Scale for the Assessment of Negative Symptoms (SANS-18) Total Score at Day 5: 150 mg | Baseline and Day 5 | The SANS was modified by eliminating the global and attention items; the score of the remaining non-global items is referred to as the SANS-18 total score. Each of the 18-items is scored on a scale from 0 (not at all) to 5 (severe) with a total scoring range of 0 to 90. Higher scores indicate more impairment. |
| Change From Baseline in Scale for the Assessment of Negative Symptoms (SANS-18) Total Score at Day 5: 200 mg | Baseline and Day 5 | The SANS was modified by eliminating the global and attention items; the score of the remaining non-global items is referred to as the SANS-18 total score. Each of the 18-items is scored on a scale from 0 (not at all) to 5 (severe) with a total scoring range of 0 to 90. Higher scores indicate more impairment. |
| Change From Baseline in Scale for the Assessment of Negative Symptoms (SANS-18) Total Score at Day 5: 250 mg | Baseline and Day 5 | The SANS was modified by eliminating the global and attention items; the score of the remaining non-global items is referred to as the SANS-18 total score. Each of the 18-items is scored on a scale from 0 (not at all) to 5 (severe) with a total scoring range of 0 to 90. Higher scores indicate more impairment. |
| Change From Baseline in Calgary Depression Scale for Schizophrenia (CDSS) Total Score at Day 5: 50 mg | Baseline and Day 5 | CDSS is a 9-item scale to evaluate depression in subjects who have schizophrenia rated from 0 (absence of symptoms) to 3 (severe symptoms) with a total score range of 0 to 27. Lower scores indicate less depression. |
| Change From Baseline in Calgary Depression Scale for Schizophrenia (CDSS) Total Score at Day 5: 70 mg | Baseline and Day 5 | CDSS is a 9-item scale to evaluate depression in subjects who have schizophrenia rated from 0 (absence of symptoms) to 3 (severe symptoms) with a total score range of 0 to 27. Lower scores indicate less depression. |
| Change From Baseline in Calgary Depression Scale for Schizophrenia (CDSS) Total Score at Day 5: 100 mg | Baseline and Day 5 | CDSS is a 9-item scale to evaluate depression in subjects who have schizophrenia rated from 0 (absence of symptoms) to 3 (severe symptoms) with a total score range of 0 to 27. Lower scores indicate less depression. |
| Change From Baseline in Calgary Depression Scale for Schizophrenia (CDSS) Total Score at Day 5: 150 mg | Baseline and Day 5 | CDSS is a 9-item scale to evaluate depression in subjects who have schizophrenia rated from 0 (absence of symptoms) to 3 (severe symptoms) with a total score range of 0 to 27. Lower scores indicate less depression. |
| Change From Baseline in Calgary Depression Scale for Schizophrenia (CDSS) Total Score at Day 5: 200 mg | Baseline and Day 5 | CDSS is a 9-item scale to evaluate depression in subjects who have schizophrenia rated from 0 (absence of symptoms) to 3 (severe symptoms) with a total score range of 0 to 27. Lower scores indicate less depression. |
| Change From Baseline in Calgary Depression Scale for Schizophrenia (CDSS) Total Score at Day 5: 250 mg | Baseline and Day 5 | CDSS is a 9-item scale to evaluate depression in subjects who have schizophrenia rated from 0 (absence of symptoms) to 3 (severe symptoms) with a total score range of 0 to 27. Lower scores indicate less depression. |
| Change From Baseline in Simpson Angus Scale (SAS) Total Score at Day 5: 50 mg | Baseline and Day 5 | SAS is a 10-item scale used to evaluate the presence and severity of extrapyramidal symptoms. The items are scored on a scale from 0 to 4 with item-specific definitions given for each point. Total scores range from 0 to 40. Lower scores indicate less impairment. |
| Change From Baseline in Simpson Angus Scale (SAS) Total Score at Day 5: 70 mg | Baseline and Day 5 | SAS is a 10-item scale used to evaluate the presence and severity of extrapyramidal symptoms. The items are scored on a scale from 0 to 4 with item-specific definitions given for each point. Total scores range from 0 to 40. Lower scores indicate less impairment. |
| Change From Baseline in Simpson Angus Scale (SAS) Total Score at Day 5: 100 mg | Baseline and Day 5 | SAS is a 10-item scale used to evaluate the presence and severity of extrapyramidal symptoms. The items are scored on a scale from 0 to 4 with item-specific definitions given for each point. Total scores range from 0 to 40. Lower scores indicate less impairment. |
| Change From Baseline in Simpson Angus Scale (SAS) Total Score at Day 5: 150 mg | Baseline and Day 5 | SAS is a 10-item scale used to evaluate the presence and severity of extrapyramidal symptoms. The items are scored on a scale from 0 to 4 with item-specific definitions given for each point. Total scores range from 0 to 40. Lower scores indicate less impairment. |
| Change From Baseline in Simpson Angus Scale (SAS) Total Score at Day 5: 200 mg | Baseline and Day 5 | SAS is a 10-item scale used to evaluate the presence and severity of extrapyramidal symptoms. The items are scored on a scale from 0 to 4 with item-specific definitions given for each point. Total scores range from 0 to 40. Lower scores indicate less impairment. |
| Change From Baseline in Simpson Angus Scale (SAS) Total Score at Day 5: 250 mg | Baseline and Day 5 | SAS is a 10-item scale used to evaluate the presence and severity of extrapyramidal symptoms. The items are scored on a scale from 0 to 4 with item-specific definitions given for each point. Total scores range from 0 to 40. Lower scores indicate less impairment. |
| Change From Baseline in Barnes Akathisia Scale (BAS) Total Score at Day 5: 50 mg | Baseline and Day 5 | BAS scale has objective, subjective, and global impression components of akathisia (motor restlessness that manifests itself with an inability to sit still or remain motionless). Objective and subjective components are rated on a scale from 0 (normal/absence) to 3 (severe) and are summed yielding a total score of 0 to 9. Global impression is rated on a scale from 0 (absent) to 5 (severe) with a total score ranging from 0 to 5. Lower scores indicate reduced restlessness. |
| Change From Baseline in Barnes Akathisia Scale (BAS) Total Score at Day 5: 70 mg | Baseline and Day 5 | BAS scale has objective, subjective, and global impression components of akathisia (motor restlessness that manifests itself with an inability to sit still or remain motionless). Objective and subjective components are rated on a scale from 0 (normal/absence) to 3 (severe) and are summed yielding a total score of 0 to 9. Global impression is rated on a scale from 0 (absent) to 5 (severe) with a total score ranging from 0 to 5. Lower scores indicate reduced restlessness. |
| Change From Baseline in Barnes Akathisia Scale (BAS) Total Score at Day 5: 100 mg | Baseline and Day 5 | BAS scale has objective, subjective, and global impression components of akathisia (motor restlessness that manifests itself with an inability to sit still or remain motionless). Objective and subjective components are rated on a scale from 0 (normal/absence) to 3 (severe) and are summed yielding a total score of 0 to 9. Global impression is rated on a scale from 0 (absent) to 5 (severe) with a total score ranging from 0 to 5. Lower scores indicate reduced restlessness. |
| Change From Baseline in Barnes Akathisia Scale (BAS) Total Score at Day 5: 150 mg | Baseline and Day 5 | BAS scale has objective, subjective, and global impression components of akathisia (motor restlessness that manifests itself with an inability to sit still or remain motionless). Objective and subjective components are rated on a scale from 0 (normal/absence) to 3 (severe) and are summed yielding a total score of 0 to 9. Global impression is rated on a scale from 0 (absent) to 5 (severe) with a total score ranging from 0 to 5. Lower scores indicate reduced restlessness. |
| Change From Baseline in Barnes Akathisia Scale (BAS) Total Score at Day 5: 200 mg | Baseline and Day 5 | BAS scale has objective, subjective, and global impression components of akathisia (motor restlessness that manifests itself with an inability to sit still or remain motionless). Objective and subjective components are rated on a scale from 0 (normal/absence) to 3 (severe) and are summed yielding a total score of 0 to 9. Global impression is rated on a scale from 0 (absent) to 5 (severe) with a total score ranging from 0 to 5. Lower scores indicate reduced restlessness. |
| Change From Baseline in Barnes Akathisia Scale (BAS) Total Score at Day 5: 250 mg | Baseline and Day 5 | BAS scale has objective, subjective, and global impression components of akathisia (motor restlessness that manifests itself with an inability to sit still or remain motionless). Objective and subjective components are rated on a scale from 0 (normal/absence) to 3 (severe) and are summed yielding a total score of 0 to 9. Global impression is rated on a scale from 0 (absent) to 5 (severe) with a total score ranging from 0 to 5. Lower scores indicate reduced restlessness. |
| Change From Baseline in Cognitive Test Battery (CogState Battery) Score at Day 5: Groton Maze Learning Test, 50 mg | Baseline and Day 5 | This battery is a series of 4 computerized cognition tests (Groton Maze Learning Test, Detection Task, Identification Task, and One Card Learning Task) designed to measure reaction time, visual learning and reasoning, and problem solving. The entire battery takes approximately 12 minutes to complete. CogState scores are measured on a linear scale (no maximum score). The Groton Maze Learning Test measures total number of errors made in problem solving (lower score = better performance). The Detection Task is measured by speed of performance (lower score = better performance). The Identification Task is measured by speed of performance (lower score = better performance). One Card Learning Task measures the accuracy of performance (higher score = better performance). |
| Change From Baseline in Cognitive Test Battery (CogState Battery) Score at Day 5: Groton Maze Learning Test, 70 mg | Baseline and Day 5 | This battery is a series of 4 computerized cognition tests (Groton Maze Learning Test, Detection Task, Identification Task, and One Card Learning Task) designed to measure reaction time, visual learning and reasoning, and problem solving. The entire battery takes approximately 12 minutes to complete. CogState scores are measured on a linear scale (no maximum score). The Groton Maze Learning Test measures total number of errors made in problem solving (lower score = better performance). The Detection Task is measured by speed of performance (lower score = better performance). The Identification Task is measured by speed of performance (lower score = better performance). One Card Learning Task measures the accuracy of performance (higher score = better performance). |
| Change From Baseline in Cognitive Test Battery (CogState Battery) Score at Day 5: Groton Maze Learning Test, 100 mg | Baseline and Day 5 | This battery is a series of 4 computerized cognition tests (Groton Maze Learning Test, Detection Task, Identification Task, and One Card Learning Task) designed to measure reaction time, visual learning and reasoning, and problem solving. The entire battery takes approximately 12 minutes to complete. CogState scores are measured on a linear scale (no maximum score). The Groton Maze Learning Test measures total number of errors made in problem solving (lower score = better performance). The Detection Task is measured by speed of performance (lower score = better performance). The Identification Task is measured by speed of performance (lower score = better performance). One Card Learning Task measures the accuracy of performance (higher score = better performance). |
| Change From Baseline in Cognitive Test Battery (CogState Battery) Score at Day 5: Groton Maze Learning Test, 150 mg | Baseline and Day 5 | This battery is a series of 4 computerized cognition tests (Groton Maze Learning Test, Detection Task, Identification Task, and One Card Learning Task) designed to measure reaction time, visual learning and reasoning, and problem solving. The entire battery takes approximately 12 minutes to complete. CogState scores are measured on a linear scale (no maximum score). The Groton Maze Learning Test measures total number of errors made in problem solving (lower score = better performance). The Detection Task is measured by speed of performance (lower score = better performance). The Identification Task is measured by speed of performance (lower score = better performance). One Card Learning Task measures the accuracy of performance (higher score = better performance). |
| Change From Baseline in Cognitive Test Battery (CogState Battery) Score at Day 5: Groton Maze Learning Test, 200 mg | Baseline and Day 5 | This battery is a series of 4 computerized cognition tests (Groton Maze Learning Test, Detection Task, Identification Task, and One Card Learning Task) designed to measure reaction time, visual learning and reasoning, and problem solving. The entire battery takes approximately 12 minutes to complete. CogState scores are measured on a linear scale (no maximum score). The Groton Maze Learning Test measures total number of errors made in problem solving (lower score = better performance). The Detection Task is measured by speed of performance (lower score = better performance). The Identification Task is measured by speed of performance (lower score = better performance). One Card Learning Task measures the accuracy of performance (higher score = better performance). |
| Change From Baseline in Cognitive Test Battery (CogState Battery) Score at Day 5: Groton Maze Learning Test, 250 mg | Baseline and Day 5 | This battery is a series of 4 computerized cognition tests (Groton Maze Learning Test, Detection Task, Identification Task, and One Card Learning Task) designed to measure reaction time, visual learning and reasoning, and problem solving. The entire battery takes approximately 12 minutes to complete. CogState scores are measured on a linear scale (no maximum score). The Groton Maze Learning Test measures total number of errors made in problem solving (lower score = better performance). The Detection Task is measured by speed of performance (lower score = better performance). The Identification Task is measured by speed of performance (lower score = better performance). One Card Learning Task measures the accuracy of performance (higher score = better performance). |
| Change From Baseline in Cognitive Test Battery (CogState Battery) Score at Day 5: Detection Task, 50 mg | Baseline and Day 5 | This battery is a series of 4 computerized cognition tests (Groton Maze Learning Test, Detection Task, Identification Task, and One Card Learning Task) designed to measure reaction time, visual learning and reasoning, and problem solving. The entire battery takes approximately 12 minutes to complete. CogState scores are measured on a linear scale (no maximum score). The Groton Maze Learning Test measures total number of errors made in problem solving (lower score = better performance). The Detection Task is measured by speed of performance (lower score = better performance). The Identification Task is measured by speed of performance (lower score = better performance). One Card Learning Task measures the accuracy of performance (higher score = better performance). |
| Change From Baseline in Cognitive Test Battery (CogState Battery) Score at Day 5: Detection Task, 70 mg | Baseline and Day 5 | This battery is a series of 4 computerized cognition tests (Groton Maze Learning Test, Detection Task, Identification Task, and One Card Learning Task) designed to measure reaction time, visual learning and reasoning, and problem solving. The entire battery takes approximately 12 minutes to complete. CogState scores are measured on a linear scale (no maximum score). The Groton Maze Learning Test measures total number of errors made in problem solving (lower score = better performance). The Detection Task is measured by speed of performance (lower score = better performance). The Identification Task is measured by speed of performance (lower score = better performance). One Card Learning Task measures the accuracy of performance (higher score = better performance). |
| Change From Baseline in Cognitive Test Battery (CogState Battery) Score at Day 5: Detection Task, 100 mg | Baseline and Day 5 | This battery is a series of 4 computerized cognition tests (Groton Maze Learning Test, Detection Task, Identification Task, and One Card Learning Task) designed to measure reaction time, visual learning and reasoning, and problem solving. The entire battery takes approximately 12 minutes to complete. CogState scores are measured on a linear scale (no maximum score). The Groton Maze Learning Test measures total number of errors made in problem solving (lower score = better performance). The Detection Task is measured by speed of performance (lower score = better performance). The Identification Task is measured by speed of performance (lower score = better performance). One Card Learning Task measures the accuracy of performance (higher score = better performance). |
| Change From Baseline in Cognitive Test Battery (CogState Battery) Score at Day 5: Detection Task, 150 mg | Baseline and Day 5 | This battery is a series of 4 computerized cognition tests (Groton Maze Learning Test, Detection Task, Identification Task, and One Card Learning Task) designed to measure reaction time, visual learning and reasoning, and problem solving. The entire battery takes approximately 12 minutes to complete. CogState scores are measured on a linear scale (no maximum score). The Groton Maze Learning Test measures total number of errors made in problem solving (lower score = better performance). The Detection Task is measured by speed of performance (lower score = better performance). The Identification Task is measured by speed of performance (lower score = better performance). One Card Learning Task measures the accuracy of performance (higher score = better performance). |
| Area Under the Steady-state Plasma Concentration-time Curve (AUC) of Lisdexamfetamine Dimesylate on Day 5: 50 mg | Day 5 (12-hour sampling period post-dose) | AUC can be used as a measure of drug exposure. It is derived from drug concentration and time so it gives a measure how much and how long a drug stays in a body. |
| Change From Baseline in Cognitive Test Battery (CogState Battery) Score at Day 5: Detection Task, 250 mg | Baseline and Day 5 | This battery is a series of 4 computerized cognition tests (Groton Maze Learning Test, Detection Task, Identification Task, and One Card Learning Task) designed to measure reaction time, visual learning and reasoning, and problem solving. The entire battery takes approximately 12 minutes to complete. CogState scores are measured on a linear scale (no maximum score). The Groton Maze Learning Test measures total number of errors made in problem solving (lower score = better performance). The Detection Task is measured by speed of performance (lower score = better performance). The Identification Task is measured by speed of performance (lower score = better performance). One Card Learning Task measures the accuracy of performance (higher score = better performance). |
| Change From Baseline in Cognitive Test Battery (CogState Battery) Score at Day 5: Identification Task, 50 mg | Baseline and Day 5 | This battery is a series of 4 computerized cognition tests (Groton Maze Learning Test, Detection Task, Identification Task, and One Card Learning Task) designed to measure reaction time, visual learning and reasoning, and problem solving. The entire battery takes approximately 12 minutes to complete. CogState scores are measured on a linear scale (no maximum score). The Groton Maze Learning Test measures total number of errors made in problem solving (lower score = better performance). The Detection Task is measured by speed of performance (lower score = better performance). The Identification Task is measured by speed of performance (lower score = better performance). One Card Learning Task measures the accuracy of performance (higher score = better performance). |
| Change From Baseline in Cognitive Test Battery (CogState Battery) Score at Day 5: Identification Task, 70 mg | Baseline and Day 5 | This battery is a series of 4 computerized cognition tests (Groton Maze Learning Test, Detection Task, Identification Task, and One Card Learning Task) designed to measure reaction time, visual learning and reasoning, and problem solving. The entire battery takes approximately 12 minutes to complete. CogState scores are measured on a linear scale (no maximum score). The Groton Maze Learning Test measures total number of errors made in problem solving (lower score = better performance). The Detection Task is measured by speed of performance (lower score = better performance). The Identification Task is measured by speed of performance (lower score = better performance). One Card Learning Task measures the accuracy of performance (higher score = better performance). |
| Change From Baseline in Cognitive Test Battery (CogState Battery) Score at Day 5: Identification Task, 100 mg | Baseline and Day 5 | This battery is a series of 4 computerized cognition tests (Groton Maze Learning Test, Detection Task, Identification Task, and One Card Learning Task) designed to measure reaction time, visual learning and reasoning, and problem solving. The entire battery takes approximately 12 minutes to complete. CogState scores are measured on a linear scale (no maximum score). The Groton Maze Learning Test measures total number of errors made in problem solving (lower score = better performance). The Detection Task is measured by speed of performance (lower score = better performance). The Identification Task is measured by speed of performance (lower score = better performance). One Card Learning Task measures the accuracy of performance (higher score = better performance). |
| Change From Baseline in Cognitive Test Battery (CogState Battery) Score at Day 5: Identification Task, 150 mg | Baseline and Day 5 | This battery is a series of 4 computerized cognition tests (Groton Maze Learning Test, Detection Task, Identification Task, and One Card Learning Task) designed to measure reaction time, visual learning and reasoning, and problem solving. The entire battery takes approximately 12 minutes to complete. CogState scores are measured on a linear scale (no maximum score). The Groton Maze Learning Test measures total number of errors made in problem solving (lower score = better performance). The Detection Task is measured by speed of performance (lower score = better performance). The Identification Task is measured by speed of performance (lower score = better performance). One Card Learning Task measures the accuracy of performance (higher score = better performance). |
| Change From Baseline in Cognitive Test Battery (CogState Battery) Score at Day 5: Identification Task, 200 mg | Baseline and Day 5 | This battery is a series of 4 computerized cognition tests (Groton Maze Learning Test, Detection Task, Identification Task, and One Card Learning Task) designed to measure reaction time, visual learning and reasoning, and problem solving. The entire battery takes approximately 12 minutes to complete. CogState scores are measured on a linear scale (no maximum score). The Groton Maze Learning Test measures total number of errors made in problem solving (lower score = better performance). The Detection Task is measured by speed of performance (lower score = better performance). The Identification Task is measured by speed of performance (lower score = better performance). One Card Learning Task measures the accuracy of performance (higher score = better performance). |
| Change From Baseline in Cognitive Test Battery (CogState Battery) Score at Day 5: Identification Task, 250 mg | Baseline and Day 5 | This battery is a series of 4 computerized cognition tests (Groton Maze Learning Test, Detection Task, Identification Task, and One Card Learning Task) designed to measure reaction time, visual learning and reasoning, and problem solving. The entire battery takes approximately 12 minutes to complete. CogState scores are measured on a linear scale (no maximum score). The Groton Maze Learning Test measures total number of errors made in problem solving (lower score = better performance). The Detection Task is measured by speed of performance (lower score = better performance). The Identification Task is measured by speed of performance (lower score = better performance). One Card Learning Task measures the accuracy of performance (higher score = better performance). |
| Change From Baseline in Cognitive Test Battery (CogState Battery) Score at Day 5: One Card Learning Task, 50 mg | Baseline and Day 5 | This battery is a series of 4 computerized cognition tests (Groton Maze Learning Test, Detection Task, Identification Task, and One Card Learning Task) designed to measure reaction time, visual learning and reasoning, and problem solving. The entire battery takes approximately 12 minutes to complete. CogState scores are measured on a linear scale (no maximum score). The Groton Maze Learning Test measures total number of errors made in problem solving (lower score = better performance). The Detection Task is measured by speed of performance (lower score = better performance). The Identification Task is measured by speed of performance (lower score = better performance). One Card Learning Task measures the accuracy of performance (higher score = better performance). |
| Change From Baseline in Cognitive Test Battery (CogState Battery) Score at Day 5: One Card Learning Task, 70 mg | Baseline and Day 5 | This battery is a series of 4 computerized cognition tests (Groton Maze Learning Test, Detection Task, Identification Task, and One Card Learning Task) designed to measure reaction time, visual learning and reasoning, and problem solving. The entire battery takes approximately 12 minutes to complete. CogState scores are measured on a linear scale (no maximum score). The Groton Maze Learning Test measures total number of errors made in problem solving (lower score = better performance). The Detection Task is measured by speed of performance (lower score = better performance). The Identification Task is measured by speed of performance (lower score = better performance). One Card Learning Task measures the accuracy of performance (higher score = better performance). |
| Change From Baseline in Cognitive Test Battery (CogState Battery) Score at Day 5: One Card Learning Task, 100 mg | Baseline and Day 5 | This battery is a series of 4 computerized cognition tests (Groton Maze Learning Test, Detection Task, Identification Task, and One Card Learning Task) designed to measure reaction time, visual learning and reasoning, and problem solving. The entire battery takes approximately 12 minutes to complete. CogState scores are measured on a linear scale (no maximum score). The Groton Maze Learning Test measures total number of errors made in problem solving (lower score = better performance). The Detection Task is measured by speed of performance (lower score = better performance). The Identification Task is measured by speed of performance (lower score = better performance). One Card Learning Task measures the accuracy of performance (higher score = better performance). |
| Change From Baseline in Cognitive Test Battery (CogState Battery) Score at Day 5: One Card Learning Task, 150 mg | Baseline and Day 5 | This battery is a series of 4 computerized cognition tests (Groton Maze Learning Test, Detection Task, Identification Task, and One Card Learning Task) designed to measure reaction time, visual learning and reasoning, and problem solving. The entire battery takes approximately 12 minutes to complete. CogState scores are measured on a linear scale (no maximum score). The Groton Maze Learning Test measures total number of errors made in problem solving (lower score = better performance). The Detection Task is measured by speed of performance (lower score = better performance). The Identification Task is measured by speed of performance (lower score = better performance). One Card Learning Task measures the accuracy of performance (higher score = better performance). |
| Change From Baseline in Cognitive Test Battery (CogState Battery) Score at Day 5: One Card Learning Task, 200 mg | Baseline and Day 5 | This battery is a series of 4 computerized cognition tests (Groton Maze Learning Test, Detection Task, Identification Task, and One Card Learning Task) designed to measure reaction time, visual learning and reasoning, and problem solving. The entire battery takes approximately 12 minutes to complete. CogState scores are measured on a linear scale (no maximum score). The Groton Maze Learning Test measures total number of errors made in problem solving (lower score = better performance). The Detection Task is measured by speed of performance (lower score = better performance). The Identification Task is measured by speed of performance (lower score = better performance). One Card Learning Task measures the accuracy of performance (higher score = better performance). |
| Change From Baseline in Cognitive Test Battery (CogState Battery) Score at Day 5: One Card Learning Task, 250 mg | Baseline and Day 5 | This battery is a series of 4 computerized cognition tests (Groton Maze Learning Test, Detection Task, Identification Task, and One Card Learning Task) designed to measure reaction time, visual learning and reasoning, and problem solving. The entire battery takes approximately 12 minutes to complete. CogState scores are measured on a linear scale (no maximum score). The Groton Maze Learning Test measures total number of errors made in problem solving (lower score = better performance). The Detection Task is measured by speed of performance (lower score = better performance). The Identification Task is measured by speed of performance (lower score = better performance). One Card Learning Task measures the accuracy of performance (higher score = better performance). |
| Change From Baseline in Cognitive Test Battery (CogState Battery) Score at Day 5: Detection Task, 200 mg | Baseline and Day 5 | This battery is a series of 4 computerized cognition tests (Groton Maze Learning Test, Detection Task, Identification Task, and One Card Learning Task) designed to measure reaction time, visual learning and reasoning, and problem solving. The entire battery takes approximately 12 minutes to complete. CogState scores are measured on a linear scale (no maximum score). The Groton Maze Learning Test measures total number of errors made in problem solving (lower score = better performance). The Detection Task is measured by speed of performance (lower score = better performance). The Identification Task is measured by speed of performance (lower score = better performance). One Card Learning Task measures the accuracy of performance (higher score = better performance). |
| Area Under the Steady-state Plasma Concentration-time Curve (AUC) of Lisdexamfetamine Dimesylate on Day 5: 70 mg | Day 5 (12-hour sampling period post-dose) | AUC can be used as a measure of drug exposure. It is derived from drug concentration and time so it gives a measure how much and how long a drug stays in a body. |
| Area Under the Steady-state Plasma Concentration-time Curve (AUC) of Lisdexamfetamine Dimesylate on Day 5: 100 mg | Day 5 (12-hour sampling period post-dose) | AUC can be used as a measure of drug exposure. It is derived from drug concentration and time so it gives a measure how much and how long a drug stays in a body. |
| Area Under the Steady-state Plasma Concentration-time Curve (AUC) of Lisdexamfetamine Dimesylate on Day 5: 150 mg | Day 5 (12-hour sampling period post-dose) | AUC can be used as a measure of drug exposure. It is derived from drug concentration and time so it gives a measure how much and how long a drug stays in a body. |
| Area Under the Steady-state Plasma Concentration-time Curve (AUC) of Lisdexamfetamine Dimesylate on Day 5: 200 mg | Day 5 (12-hour sampling period post-dose) | AUC can be used as a measure of drug exposure. It is derived from drug concentration and time so it gives a measure how much and how long a drug stays in a body. |
| Area Under the Steady-state Plasma Concentration-time Curve (AUC) of Lisdexamfetamine Dimesylate on Day 5: 250 mg | Day 5 (12-hour sampling period post-dose) | AUC can be used as a measure of drug exposure. It is derived from drug concentration and time so it gives a measure how much and how long a drug stays in a body. |
| Maximum Plasma Concentration (Cmax) of Lisdexamfetamine Dimesylate on Day 5: 50 mg | Day 5 (12-hour sampling period post-dose) | Cmax is a term that refers to the maximum (or peak) concentration that a drug achieves in the body after the drug has been administrated. |
| Maximum Plasma Concentration (Cmax) of Lisdexamfetamine Dimesylate on Day 5: 70 mg | Day 5 (12-hour sampling period post-dose) | Cmax is a term that refers to the maximum (or peak) concentration that a drug achieves in the body after the drug has been administrated. |
| Maximum Plasma Concentration (Cmax) of Lisdexamfetamine Dimesylate on Day 5: 100 mg | Day 5 (12-hour sampling period post-dose) | Cmax is a term that refers to the maximum (or peak) concentration that a drug achieves in the body after the drug has been administrated. |
| Maximum Plasma Concentration (Cmax) of Lisdexamfetamine Dimesylate on Day 5: 150 mg | Day 5 (12-hour sampling period post-dose) | Cmax is a term that refers to the maximum (or peak) concentration that a drug achieves in the body after the drug has been administrated. |
| Maximum Plasma Concentration (Cmax) of Lisdexamfetamine Dimesylate on Day 5: 200 mg | Day 5 (12-hour sampling period post-dose) | Cmax is a term that refers to the maximum (or peak) concentration that a drug achieves in the body after the drug has been administrated. |
| Maximum Plasma Concentration (Cmax) of Lisdexamfetamine Dimesylate on Day 5: 250 mg | Day 5 (12-hour sampling period post-dose) | Cmax is a term that refers to the maximum (or peak) concentration that a drug achieves in the body after the drug has been administrated. |
| Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score at Day 5: 50 mg | Baseline and Day 5 | The PANSS is a validated measure that evaluates the presence, absence, and severity of 30 symptoms of schizophrenia including both positive and negative symptoms and general psychopathology. Each of the 30-items are rated on a scale of 1 (absent) to 7 (extreme) with a total scoring range of 30 to 210. Higher scores indicate more impairment. |
| Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score at Day 5: 70 mg | Baseline and Day 5 | The PANSS is a validated measure that evaluates the presence, absence, and severity of 30 symptoms of schizophrenia including both positive and negative symptoms and general psychopathology. Each of the 30-items are rated on a scale of 1 (absent) to 7 (extreme) with a total scoring range of 30 to 210. Higher scores indicate more impairment. |
| Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score at Day 5: 100 mg | Baseline and Day 5 | The PANSS is a validated measure that evaluates the presence, absence, and severity of 30 symptoms of schizophrenia including both positive and negative symptoms and general psychopathology. Each of the 30-items are rated on a scale of 1 (absent) to 7 (extreme) with a total scoring range of 30 to 210. Higher scores indicate more impairment. |
| Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score at Day 5: 150 mg | Baseline and Day 5 | The PANSS is a validated measure that evaluates the presence, absence, and severity of 30 symptoms of schizophrenia including both positive and negative symptoms and general psychopathology. Each of the 30-items are rated on a scale of 1 (absent) to 7 (extreme) with a total scoring range of 30 to 210. Higher scores indicate more impairment. |
| Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score at Day 5: 200 mg | Baseline and Day 5 | The PANSS is a validated measure that evaluates the presence, absence, and severity of 30 symptoms of schizophrenia including both positive and negative symptoms and general psychopathology. Each of the 30-items are rated on a scale of 1 (absent) to 7 (extreme) with a total scoring range of 30 to 210. Higher scores indicate more impairment. |
| Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score at Day 5: 250 mg | Baseline and Day 5 | The PANSS is a validated measure that evaluates the presence, absence, and severity of 30 symptoms of schizophrenia including both positive and negative symptoms and general psychopathology. Each of the 30-items are rated on a scale of 1 (absent) to 7 (extreme) with a total scoring range of 30 to 210. Higher scores indicate more impairment. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Placebo Placebo Capsule(s) for oral use taken once daily for 30 days | 7 |
| SPD489 (Lisdexamfetamine Dimesylate)(All Doses) Ascending multiple, oral doses of SPD489 (50mg, 70mg, 100mg, 150mg, 200mg, 250mg) administered once daily for 5 days at each dose level (30 days total). | 24 |
| Total | 31 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Period 3 (100 mg) | Adverse Event | 0 | 1 |
| Period 5 (200 mg) | Met stopping criteria for PANSS score | 0 | 1 |
| Period 6 (250 mg) | Family Emergency | 1 | 0 |
| Period 6 (250 mg) | Personal appointment | 0 | 1 |
Baseline characteristics
| Characteristic | SPD489 (Lisdexamfetamine Dimesylate)(All Doses) | Placebo | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 24 Participants | 7 Participants | 31 Participants |
| Age, Continuous | 46.4 years STANDARD_DEVIATION 7.86 | 49.6 years STANDARD_DEVIATION 4.93 | 47.1 years STANDARD_DEVIATION 7.35 |
| Region of Enrollment United States | 24 Participants | 7 Participants | 31 Participants |
| Sex: Female, Male Female | 5 Participants | 1 Participants | 6 Participants |
| Sex: Female, Male Male | 19 Participants | 6 Participants | 25 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk | EG006 affected / at risk | EG007 affected / at risk |
|---|---|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 4 / 7 | 15 / 24 | 7 / 24 | 8 / 24 | 12 / 23 | 10 / 23 | 12 / 22 | 23 / 24 |
| serious Total, serious adverse events | 0 / 7 | 0 / 24 | 0 / 24 | 0 / 24 | 0 / 23 | 0 / 23 | 0 / 22 | 0 / 24 |
Outcome results
Primary
Change From Baseline in Diastolic Blood Pressure at Day 5: 100 mg
Blood pressure and pulse measurements were taken using an automated blood pressure monitoring device (ideally using the same device, the same arm and in the same position throughout the study). Measurements of vital signs were performed in triplicate (3 measurements) after the subject had been in a sitting position for at least 5 minutes. Each of the 3 triplicate readings were performed in succession, at least 1-2 minutes apart, with the cuff fully deflated between measurements. It was expected that the triplicate measurements be obtained within a 5-6 minute period.
Time frame: Baseline and day 5
Population: Safety Set consisted of subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in Diastolic Blood Pressure at Day 5: 100 mg | 2.14 mmHg | Standard Deviation 7.796 |
| SPD489 (Lisdexamfetamine Dimesylate)(50 mg) | Change From Baseline in Diastolic Blood Pressure at Day 5: 100 mg | 4.55 mmHg | Standard Deviation 7.641 |
Primary
Change From Baseline in Diastolic Blood Pressure at Day 5: 150 mg
Blood pressure and pulse measurements were taken using an automated blood pressure monitoring device (ideally using the same device, the same arm and in the same position throughout the study). Measurements of vital signs were performed in triplicate (3 measurements) after the subject had been in a sitting position for at least 5 minutes. Each of the 3 triplicate readings were performed in succession, at least 1-2 minutes apart, with the cuff fully deflated between measurements. It was expected that the triplicate measurements be obtained within a 5-6 minute period.
Time frame: Baseline and day 5
Population: Safety Set consisted of subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in Diastolic Blood Pressure at Day 5: 150 mg | 2.67 mmHg | Standard Deviation 10.846 |
| SPD489 (Lisdexamfetamine Dimesylate)(50 mg) | Change From Baseline in Diastolic Blood Pressure at Day 5: 150 mg | 2.43 mmHg | Standard Deviation 10.672 |
Primary
Change From Baseline in Diastolic Blood Pressure at Day 5: 200 mg
Blood pressure and pulse measurements were taken using an automated blood pressure monitoring device (ideally using the same device, the same arm and in the same position throughout the study). Measurements of vital signs were performed in triplicate (3 measurements) after the subject had been in a sitting position for at least 5 minutes. Each of the 3 triplicate readings were performed in succession, at least 1-2 minutes apart, with the cuff fully deflated between measurements. It was expected that the triplicate measurements be obtained within a 5-6 minute period.
Time frame: Baseline and day 5
Population: Safety Set consisted of subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in Diastolic Blood Pressure at Day 5: 200 mg | 2.76 mmHg | Standard Deviation 14.442 |
| SPD489 (Lisdexamfetamine Dimesylate)(50 mg) | Change From Baseline in Diastolic Blood Pressure at Day 5: 200 mg | 3.77 mmHg | Standard Deviation 8.041 |
Primary
Change From Baseline in Diastolic Blood Pressure at Day 5: 250 mg
Blood pressure and pulse measurements were taken using an automated blood pressure monitoring device (ideally using the same device, the same arm and in the same position throughout the study). Measurements of vital signs were performed in triplicate (3 measurements) after the subject had been in a sitting position for at least 5 minutes. Each of the 3 triplicate readings were performed in succession, at least 1-2 minutes apart, with the cuff fully deflated between measurements. It was expected that the triplicate measurements be obtained within a 5-6 minute period.
Time frame: Baseline and day 5
Population: Safety Set consisted of subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in Diastolic Blood Pressure at Day 5: 250 mg | 3.67 mmHg | Standard Deviation 8.618 |
| SPD489 (Lisdexamfetamine Dimesylate)(50 mg) | Change From Baseline in Diastolic Blood Pressure at Day 5: 250 mg | 3.79 mmHg | Standard Deviation 10.106 |
Primary
Change From Baseline in Diastolic Blood Pressure at Day 5: 50 mg
Blood pressure and pulse measurements were taken using an automated blood pressure monitoring device (ideally using the same device, the same arm and in the same position throughout the study). Measurements of vital signs were performed in triplicate (3 measurements) after the subject had been in a sitting position for at least 5 minutes. Each of the 3 triplicate readings were performed in succession, at least 1-2 minutes apart, with the cuff fully deflated between measurements. It was expected that the triplicate measurements be obtained within a 5-6 minute period.
Time frame: Baseline and day 5
Population: Safety Set consisted of subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in Diastolic Blood Pressure at Day 5: 50 mg | 2.86 mmHg | Standard Deviation 11.547 |
| SPD489 (Lisdexamfetamine Dimesylate)(50 mg) | Change From Baseline in Diastolic Blood Pressure at Day 5: 50 mg | 5.22 mmHg | Standard Deviation 8.364 |
Primary
Change From Baseline in Diastolic Blood Pressure at Day 5: 70 mg
Blood pressure and pulse measurements were taken using an automated blood pressure monitoring device (ideally using the same device, the same arm and in the same position throughout the study). Measurements of vital signs were performed in triplicate (3 measurements) after the subject had been in a sitting position for at least 5 minutes. Each of the 3 triplicate readings were performed in succession, at least 1-2 minutes apart, with the cuff fully deflated between measurements. It was expected that the triplicate measurements be obtained within a 5-6 minute period.
Time frame: Baseline and day 5
Population: Safety Set consisted of subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in Diastolic Blood Pressure at Day 5: 70 mg | 2.38 mmHg | Standard Deviation 10.557 |
| SPD489 (Lisdexamfetamine Dimesylate)(50 mg) | Change From Baseline in Diastolic Blood Pressure at Day 5: 70 mg | 2.14 mmHg | Standard Deviation 6.468 |
Primary
Change From Baseline in Pulse Rate at Day 5: 100 mg
Blood pressure and pulse measurements were taken using an automated blood pressure monitoring device (ideally using the same device, the same arm and in the same position throughout the study). Measurements of vital signs were performed in triplicate (3 measurements) after the subject had been in a sitting position for at least 5 minutes. Each of the 3 triplicate readings were performed in succession, at least 1-2 minutes apart, with the cuff fully deflated between measurements. It was expected that the triplicate measurements be obtained within a 5-6 minute period.
Time frame: Baseline and day 5
Population: Safety Set consisted of subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in Pulse Rate at Day 5: 100 mg | 0.19 beats/min | Standard Deviation 10.306 |
| SPD489 (Lisdexamfetamine Dimesylate)(50 mg) | Change From Baseline in Pulse Rate at Day 5: 100 mg | 5.72 beats/min | Standard Deviation 12.578 |
Primary
Change From Baseline in Pulse Rate at Day 5: 150 mg
Blood pressure and pulse measurements were taken using an automated blood pressure monitoring device (ideally using the same device, the same arm and in the same position throughout the study). Measurements of vital signs were performed in triplicate (3 measurements) after the subject had been in a sitting position for at least 5 minutes. Each of the 3 triplicate readings were performed in succession, at least 1-2 minutes apart, with the cuff fully deflated between measurements. It was expected that the triplicate measurements be obtained within a 5-6 minute period.
Time frame: Baseline and day 5
Population: Safety Set consisted of subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in Pulse Rate at Day 5: 150 mg | -1.05 beats/min | Standard Deviation 8.125 |
| SPD489 (Lisdexamfetamine Dimesylate)(50 mg) | Change From Baseline in Pulse Rate at Day 5: 150 mg | 6.41 beats/min | Standard Deviation 13.782 |
Primary
Change From Baseline in Pulse Rate at Day 5: 200 mg
Blood pressure and pulse measurements were taken using an automated blood pressure monitoring device (ideally using the same device, the same arm and in the same position throughout the study). Measurements of vital signs were performed in triplicate (3 measurements) after the subject had been in a sitting position for at least 5 minutes. Each of the 3 triplicate readings were performed in succession, at least 1-2 minutes apart, with the cuff fully deflated between measurements. It was expected that the triplicate measurements be obtained within a 5-6 minute period.
Time frame: Baseline and day 5
Population: Safety Set consisted of subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in Pulse Rate at Day 5: 200 mg | 2.38 beats/min | Standard Deviation 10.058 |
| SPD489 (Lisdexamfetamine Dimesylate)(50 mg) | Change From Baseline in Pulse Rate at Day 5: 200 mg | 8.88 beats/min | Standard Deviation 12.206 |
Primary
Change From Baseline in Pulse Rate at Day 5: 250 mg
Blood pressure and pulse measurements were taken using an automated blood pressure monitoring device (ideally using the same device, the same arm and in the same position throughout the study). Measurements of vital signs were performed in triplicate (3 measurements) after the subject had been in a sitting position for at least 5 minutes. Each of the 3 triplicate readings were performed in succession, at least 1-2 minutes apart, with the cuff fully deflated between measurements. It was expected that the triplicate measurements be obtained within a 5-6 minute period.
Time frame: Baseline and day 5
Population: Safety Set consisted of subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in Pulse Rate at Day 5: 250 mg | 2.06 beats/min | Standard Deviation 9.76 |
| SPD489 (Lisdexamfetamine Dimesylate)(50 mg) | Change From Baseline in Pulse Rate at Day 5: 250 mg | 12.39 beats/min | Standard Deviation 12.666 |
Primary
Change From Baseline in Pulse Rate at Day 5: 50 mg
Blood pressure and pulse measurements were taken using an automated blood pressure monitoring device (ideally using the same device, the same arm and in the same position throughout the study). Measurements of vital signs were performed in triplicate (3 measurements) after the subject had been in a sitting position for at least 5 minutes. Each of the 3 triplicate readings were performed in succession, at least 1-2 minutes apart, with the cuff fully deflated between measurements. It was expected that the triplicate measurements be obtained within a 5-6 minute period.
Time frame: Baseline and day 5
Population: Safety Set consisted of subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in Pulse Rate at Day 5: 50 mg | 2.62 beats/min | Standard Deviation 9.534 |
| SPD489 (Lisdexamfetamine Dimesylate)(50 mg) | Change From Baseline in Pulse Rate at Day 5: 50 mg | 3.78 beats/min | Standard Deviation 11.116 |
Primary
Change From Baseline in Pulse Rate at Day 5: 70 mg
Blood pressure and pulse measurements were taken using an automated blood pressure monitoring device (ideally using the same device, the same arm and in the same position throughout the study). Measurements of vital signs were performed in triplicate (3 measurements) after the subject had been in a sitting position for at least 5 minutes. Each of the 3 triplicate readings were performed in succession, at least 1-2 minutes apart, with the cuff fully deflated between measurements. It was expected that the triplicate measurements be obtained within a 5-6 minute period.
Time frame: Baseline and day 5
Population: Safety Set consisted of subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in Pulse Rate at Day 5: 70 mg | -0.95 beats/min | Standard Deviation 9.821 |
| SPD489 (Lisdexamfetamine Dimesylate)(50 mg) | Change From Baseline in Pulse Rate at Day 5: 70 mg | 5.07 beats/min | Standard Deviation 9.5 |
Primary
Change From Baseline in Systolic Blood Pressure at Day 5: 100 mg
Blood pressure and pulse measurements were taken using an automated blood pressure monitoring device (ideally using the same device, the same arm and in the same position throughout the study). Measurements of vital signs were performed in triplicate (3 measurements) after the subject had been in a sitting position for at least 5 minutes. Each of the 3 triplicate readings were performed in succession, at least 1-2 minutes apart, with the cuff fully deflated between measurements. It was expected that the triplicate measurements be obtained within a 5-6 minute period.
Time frame: Baseline and day 5
Population: Safety Set consisted of subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in Systolic Blood Pressure at Day 5: 100 mg | 0.43 mmHg | Standard Deviation 6.448 |
| SPD489 (Lisdexamfetamine Dimesylate)(50 mg) | Change From Baseline in Systolic Blood Pressure at Day 5: 100 mg | 4.96 mmHg | Standard Deviation 9.208 |
Primary
Change From Baseline in Systolic Blood Pressure at Day 5: 150 mg
Blood pressure and pulse measurements were taken using an automated blood pressure monitoring device (ideally using the same device, the same arm and in the same position throughout the study). Measurements of vital signs were performed in triplicate (3 measurements) after the subject had been in a sitting position for at least 5 minutes. Each of the 3 triplicate readings were performed in succession, at least 1-2 minutes apart, with the cuff fully deflated between measurements. It was expected that the triplicate measurements be obtained within a 5-6 minute period.
Time frame: Baseline and day 5
Population: Safety Set consisted of subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in Systolic Blood Pressure at Day 5: 150 mg | -2.81 mmHg | Standard Deviation 7.358 |
| SPD489 (Lisdexamfetamine Dimesylate)(50 mg) | Change From Baseline in Systolic Blood Pressure at Day 5: 150 mg | 6.43 mmHg | Standard Deviation 13.519 |
Primary
Change From Baseline in Systolic Blood Pressure at Day 5: 200 mg
Blood pressure and pulse measurements were taken using an automated blood pressure monitoring device (ideally using the same device, the same arm and in the same position throughout the study). Measurements of vital signs were performed in triplicate (3 measurements) after the subject had been in a sitting position for at least 5 minutes. Each of the 3 triplicate readings were performed in succession, at least 1-2 minutes apart, with the cuff fully deflated between measurements. It was expected that the triplicate measurements be obtained within a 5-6 minute period.
Time frame: Baseline and day 5
Population: Safety Set consisted of subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in Systolic Blood Pressure at Day 5: 200 mg | -2.38 mmHg | Standard Deviation 11.546 |
| SPD489 (Lisdexamfetamine Dimesylate)(50 mg) | Change From Baseline in Systolic Blood Pressure at Day 5: 200 mg | 5.28 mmHg | Standard Deviation 11.761 |
Primary
Change From Baseline in Systolic Blood Pressure at Day 5: 250 mg
Blood pressure and pulse measurements were taken using an automated blood pressure monitoring device (ideally using the same device, the same arm and in the same position throughout the study). Measurements of vital signs were performed in triplicate (3 measurements) after the subject had been in a sitting position for at least 5 minutes. Each of the 3 triplicate readings were performed in succession, at least 1-2 minutes apart, with the cuff fully deflated between measurements. It was expected that the triplicate measurements be obtained within a 5-6 minute period.
Time frame: Baseline and day 5
Population: Safety Set consisted of subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in Systolic Blood Pressure at Day 5: 250 mg | -0.28 mmHg | Standard Deviation 13.442 |
| SPD489 (Lisdexamfetamine Dimesylate)(50 mg) | Change From Baseline in Systolic Blood Pressure at Day 5: 250 mg | 7.36 mmHg | Standard Deviation 15.569 |
Primary
Change From Baseline in Systolic Blood Pressure at Day 5: 50 mg
Blood pressure and pulse measurements were taken using an automated blood pressure monitoring device (ideally using the same device, the same arm and in the same position throughout the study). Measurements of vital signs were performed in triplicate (3 measurements) after the subject had been in a sitting position for at least 5 minutes. Each of the 3 triplicate readings were performed in succession, at least 1-2 minutes apart, with the cuff fully deflated between measurements. It was expected that the triplicate measurements be obtained within a 5-6 minute period.
Time frame: Baseline and day 5
Population: Safety Set consisted of subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in Systolic Blood Pressure at Day 5: 50 mg | -0.14 mmHg | Standard Deviation 9.543 |
| SPD489 (Lisdexamfetamine Dimesylate)(50 mg) | Change From Baseline in Systolic Blood Pressure at Day 5: 50 mg | 8.94 mmHg | Standard Deviation 11.51 |
Primary
Change From Baseline in Systolic Blood Pressure at Day 5: 70 mg
Blood pressure and pulse measurements were taken using an automated blood pressure monitoring device (ideally using the same device, the same arm and in the same position throughout the study). Measurements of vital signs were performed in triplicate (3 measurements) after the subject had been in a sitting position for at least 5 minutes. Each of the 3 triplicate readings were performed in succession, at least 1-2 minutes apart, with the cuff fully deflated between measurements. It was expected that the triplicate measurements be obtained within a 5-6 minute period.
Time frame: Baseline and day 5
Population: Safety Set consisted of subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in Systolic Blood Pressure at Day 5: 70 mg | 1.43 mmHg | Standard Deviation 12.593 |
| SPD489 (Lisdexamfetamine Dimesylate)(50 mg) | Change From Baseline in Systolic Blood Pressure at Day 5: 70 mg | 3.82 mmHg | Standard Deviation 9.258 |
Secondary
Area Under the Steady-state Plasma Concentration-time Curve (AUC) of Lisdexamfetamine Dimesylate on Day 5: 100 mg
AUC can be used as a measure of drug exposure. It is derived from drug concentration and time so it gives a measure how much and how long a drug stays in a body.
Time frame: Day 5 (12-hour sampling period post-dose)
Population: Pharmacokinetic Set defined as all subjects in the Safety set who had evaluable concentration-time profiles for lisdexamfetamine and/or d-amphetamine.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Area Under the Steady-state Plasma Concentration-time Curve (AUC) of Lisdexamfetamine Dimesylate on Day 5: 100 mg | 80.5 ng*hr/ml | Standard Deviation 37.2 |
Secondary
Area Under the Steady-state Plasma Concentration-time Curve (AUC) of Lisdexamfetamine Dimesylate on Day 5: 150 mg
AUC can be used as a measure of drug exposure. It is derived from drug concentration and time so it gives a measure how much and how long a drug stays in a body.
Time frame: Day 5 (12-hour sampling period post-dose)
Population: Pharmacokinetic Set defined as all subjects in the Safety set who had evaluable concentration-time profiles for lisdexamfetamine and/or d-amphetamine.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Area Under the Steady-state Plasma Concentration-time Curve (AUC) of Lisdexamfetamine Dimesylate on Day 5: 150 mg | 144.9 ng*hr/ml | Standard Deviation 43.7 |
Secondary
Area Under the Steady-state Plasma Concentration-time Curve (AUC) of Lisdexamfetamine Dimesylate on Day 5: 200 mg
AUC can be used as a measure of drug exposure. It is derived from drug concentration and time so it gives a measure how much and how long a drug stays in a body.
Time frame: Day 5 (12-hour sampling period post-dose)
Population: Pharmacokinetic Set defined as all subjects in the Safety set who had evaluable concentration-time profiles for lisdexamfetamine and/or d-amphetamine.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Area Under the Steady-state Plasma Concentration-time Curve (AUC) of Lisdexamfetamine Dimesylate on Day 5: 200 mg | 230.2 ng*hr/ml | Standard Deviation 81.1 |
Secondary
Area Under the Steady-state Plasma Concentration-time Curve (AUC) of Lisdexamfetamine Dimesylate on Day 5: 250 mg
AUC can be used as a measure of drug exposure. It is derived from drug concentration and time so it gives a measure how much and how long a drug stays in a body.
Time frame: Day 5 (12-hour sampling period post-dose)
Population: Pharmacokinetic Set defined as all subjects in the Safety set who had evaluable concentration-time profiles for lisdexamfetamine and/or d-amphetamine.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Area Under the Steady-state Plasma Concentration-time Curve (AUC) of Lisdexamfetamine Dimesylate on Day 5: 250 mg | 301.5 ng*hr/ml | Standard Deviation 105.9 |
Secondary
Area Under the Steady-state Plasma Concentration-time Curve (AUC) of Lisdexamfetamine Dimesylate on Day 5: 50 mg
AUC can be used as a measure of drug exposure. It is derived from drug concentration and time so it gives a measure how much and how long a drug stays in a body.
Time frame: Day 5 (12-hour sampling period post-dose)
Population: Pharmacokinetic Set defined as all subjects in the Safety set who had evaluable concentration-time profiles for lisdexamfetamine and/or d-amphetamine.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Area Under the Steady-state Plasma Concentration-time Curve (AUC) of Lisdexamfetamine Dimesylate on Day 5: 50 mg | 25.6 ng*hr/ml | Standard Deviation 12.9 |
Secondary
Area Under the Steady-state Plasma Concentration-time Curve (AUC) of Lisdexamfetamine Dimesylate on Day 5: 70 mg
AUC can be used as a measure of drug exposure. It is derived from drug concentration and time so it gives a measure how much and how long a drug stays in a body.
Time frame: Day 5 (12-hour sampling period post-dose)
Population: Pharmacokinetic Set defined as all subjects in the Safety set who had evaluable concentration-time profiles for lisdexamfetamine and/or d-amphetamine.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Area Under the Steady-state Plasma Concentration-time Curve (AUC) of Lisdexamfetamine Dimesylate on Day 5: 70 mg | 43.7 ng*hr/ml | Standard Deviation 27.5 |
Secondary
Change From Baseline in Barnes Akathisia Scale (BAS) Total Score at Day 5: 100 mg
BAS scale has objective, subjective, and global impression components of akathisia (motor restlessness that manifests itself with an inability to sit still or remain motionless). Objective and subjective components are rated on a scale from 0 (normal/absence) to 3 (severe) and are summed yielding a total score of 0 to 9. Global impression is rated on a scale from 0 (absent) to 5 (severe) with a total score ranging from 0 to 5. Lower scores indicate reduced restlessness.
Time frame: Baseline and Day 5
Population: Safety Set consisted of subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in Barnes Akathisia Scale (BAS) Total Score at Day 5: 100 mg | 0.0 units on a scale | Standard Error 0 |
| SPD489 (Lisdexamfetamine Dimesylate)(50 mg) | Change From Baseline in Barnes Akathisia Scale (BAS) Total Score at Day 5: 100 mg | 0.0 units on a scale | Standard Error 0 |
Secondary
Change From Baseline in Barnes Akathisia Scale (BAS) Total Score at Day 5: 150 mg
BAS scale has objective, subjective, and global impression components of akathisia (motor restlessness that manifests itself with an inability to sit still or remain motionless). Objective and subjective components are rated on a scale from 0 (normal/absence) to 3 (severe) and are summed yielding a total score of 0 to 9. Global impression is rated on a scale from 0 (absent) to 5 (severe) with a total score ranging from 0 to 5. Lower scores indicate reduced restlessness.
Time frame: Baseline and Day 5
Population: Safety Set consisted of subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in Barnes Akathisia Scale (BAS) Total Score at Day 5: 150 mg | 0.0 units on a scale | Standard Error 0 |
| SPD489 (Lisdexamfetamine Dimesylate)(50 mg) | Change From Baseline in Barnes Akathisia Scale (BAS) Total Score at Day 5: 150 mg | 0.0 units on a scale | Standard Error 0 |
Secondary
Change From Baseline in Barnes Akathisia Scale (BAS) Total Score at Day 5: 200 mg
BAS scale has objective, subjective, and global impression components of akathisia (motor restlessness that manifests itself with an inability to sit still or remain motionless). Objective and subjective components are rated on a scale from 0 (normal/absence) to 3 (severe) and are summed yielding a total score of 0 to 9. Global impression is rated on a scale from 0 (absent) to 5 (severe) with a total score ranging from 0 to 5. Lower scores indicate reduced restlessness.
Time frame: Baseline and Day 5
Population: Safety Set consisted of subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in Barnes Akathisia Scale (BAS) Total Score at Day 5: 200 mg | 0.0 units on a scale | Standard Error 0 |
| SPD489 (Lisdexamfetamine Dimesylate)(50 mg) | Change From Baseline in Barnes Akathisia Scale (BAS) Total Score at Day 5: 200 mg | 0.2 units on a scale | Standard Error 0.11 |
Secondary
Change From Baseline in Barnes Akathisia Scale (BAS) Total Score at Day 5: 250 mg
BAS scale has objective, subjective, and global impression components of akathisia (motor restlessness that manifests itself with an inability to sit still or remain motionless). Objective and subjective components are rated on a scale from 0 (normal/absence) to 3 (severe) and are summed yielding a total score of 0 to 9. Global impression is rated on a scale from 0 (absent) to 5 (severe) with a total score ranging from 0 to 5. Lower scores indicate reduced restlessness.
Time frame: Baseline and Day 5
Population: Safety Set consisted of subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in Barnes Akathisia Scale (BAS) Total Score at Day 5: 250 mg | 0.0 units on a scale | Standard Error 0 |
| SPD489 (Lisdexamfetamine Dimesylate)(50 mg) | Change From Baseline in Barnes Akathisia Scale (BAS) Total Score at Day 5: 250 mg | 0.0 units on a scale | Standard Error 0.05 |
Secondary
Change From Baseline in Barnes Akathisia Scale (BAS) Total Score at Day 5: 50 mg
BAS scale has objective, subjective, and global impression components of akathisia (motor restlessness that manifests itself with an inability to sit still or remain motionless). Objective and subjective components are rated on a scale from 0 (normal/absence) to 3 (severe) and are summed yielding a total score of 0 to 9. Global impression is rated on a scale from 0 (absent) to 5 (severe) with a total score ranging from 0 to 5. Lower scores indicate reduced restlessness.
Time frame: Baseline and Day 5
Population: Safety Set consisted of subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in Barnes Akathisia Scale (BAS) Total Score at Day 5: 50 mg | 0.0 units on a scale | Standard Error 0 |
| SPD489 (Lisdexamfetamine Dimesylate)(50 mg) | Change From Baseline in Barnes Akathisia Scale (BAS) Total Score at Day 5: 50 mg | 0.0 units on a scale | Standard Error 0 |
Secondary
Change From Baseline in Barnes Akathisia Scale (BAS) Total Score at Day 5: 70 mg
BAS scale has objective, subjective, and global impression components of akathisia (motor restlessness that manifests itself with an inability to sit still or remain motionless). Objective and subjective components are rated on a scale from 0 (normal/absence) to 3 (severe) and are summed yielding a total score of 0 to 9. Global impression is rated on a scale from 0 (absent) to 5 (severe) with a total score ranging from 0 to 5. Lower scores indicate reduced restlessness.
Time frame: Baseline and Day 5
Population: Safety Set consisted of subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in Barnes Akathisia Scale (BAS) Total Score at Day 5: 70 mg | 0.0 units on a scale | Standard Error 0 |
| SPD489 (Lisdexamfetamine Dimesylate)(50 mg) | Change From Baseline in Barnes Akathisia Scale (BAS) Total Score at Day 5: 70 mg | 0.0 units on a scale | Standard Error 0 |
Secondary
Change From Baseline in Calgary Depression Scale for Schizophrenia (CDSS) Total Score at Day 5: 100 mg
CDSS is a 9-item scale to evaluate depression in subjects who have schizophrenia rated from 0 (absence of symptoms) to 3 (severe symptoms) with a total score range of 0 to 27. Lower scores indicate less depression.
Time frame: Baseline and Day 5
Population: Safety Set consisted of subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in Calgary Depression Scale for Schizophrenia (CDSS) Total Score at Day 5: 100 mg | -0.4 units on a scale | Standard Error 0.3 |
| SPD489 (Lisdexamfetamine Dimesylate)(50 mg) | Change From Baseline in Calgary Depression Scale for Schizophrenia (CDSS) Total Score at Day 5: 100 mg | -0.9 units on a scale | Standard Error 0.34 |
Secondary
Change From Baseline in Calgary Depression Scale for Schizophrenia (CDSS) Total Score at Day 5: 150 mg
CDSS is a 9-item scale to evaluate depression in subjects who have schizophrenia rated from 0 (absence of symptoms) to 3 (severe symptoms) with a total score range of 0 to 27. Lower scores indicate less depression.
Time frame: Baseline and Day 5
Population: Safety Set consisted of subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in Calgary Depression Scale for Schizophrenia (CDSS) Total Score at Day 5: 150 mg | -0.7 units on a scale | Standard Error 0.47 |
| SPD489 (Lisdexamfetamine Dimesylate)(50 mg) | Change From Baseline in Calgary Depression Scale for Schizophrenia (CDSS) Total Score at Day 5: 150 mg | -1.0 units on a scale | Standard Error 0.35 |
Secondary
Change From Baseline in Calgary Depression Scale for Schizophrenia (CDSS) Total Score at Day 5: 200 mg
CDSS is a 9-item scale to evaluate depression in subjects who have schizophrenia rated from 0 (absence of symptoms) to 3 (severe symptoms) with a total score range of 0 to 27. Lower scores indicate less depression.
Time frame: Baseline and Day 5
Population: Safety Set consisted of subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in Calgary Depression Scale for Schizophrenia (CDSS) Total Score at Day 5: 200 mg | -0.4 units on a scale | Standard Error 0.3 |
| SPD489 (Lisdexamfetamine Dimesylate)(50 mg) | Change From Baseline in Calgary Depression Scale for Schizophrenia (CDSS) Total Score at Day 5: 200 mg | -0.6 units on a scale | Standard Error 0.28 |
Secondary
Change From Baseline in Calgary Depression Scale for Schizophrenia (CDSS) Total Score at Day 5: 250 mg
CDSS is a 9-item scale to evaluate depression in subjects who have schizophrenia rated from 0 (absence of symptoms) to 3 (severe symptoms) with a total score range of 0 to 27. Lower scores indicate less depression.
Time frame: Baseline and Day 5
Population: Safety Set consisted of subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in Calgary Depression Scale for Schizophrenia (CDSS) Total Score at Day 5: 250 mg | -0.2 units on a scale | Standard Error 0.4 |
| SPD489 (Lisdexamfetamine Dimesylate)(50 mg) | Change From Baseline in Calgary Depression Scale for Schizophrenia (CDSS) Total Score at Day 5: 250 mg | -0.3 units on a scale | Standard Error 0.48 |
Secondary
Change From Baseline in Calgary Depression Scale for Schizophrenia (CDSS) Total Score at Day 5: 50 mg
CDSS is a 9-item scale to evaluate depression in subjects who have schizophrenia rated from 0 (absence of symptoms) to 3 (severe symptoms) with a total score range of 0 to 27. Lower scores indicate less depression.
Time frame: Baseline and Day 5
Population: Safety Set consisted of subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in Calgary Depression Scale for Schizophrenia (CDSS) Total Score at Day 5: 50 mg | 0.0 units on a scale | Standard Error 0.38 |
| SPD489 (Lisdexamfetamine Dimesylate)(50 mg) | Change From Baseline in Calgary Depression Scale for Schizophrenia (CDSS) Total Score at Day 5: 50 mg | -0.3 units on a scale | Standard Error 0.35 |
Secondary
Change From Baseline in Calgary Depression Scale for Schizophrenia (CDSS) Total Score at Day 5: 70 mg
CDSS is a 9-item scale to evaluate depression in subjects who have schizophrenia rated from 0 (absence of symptoms) to 3 (severe symptoms) with a total score range of 0 to 27. Lower scores indicate less depression.
Time frame: Baseline and Day 5
Population: Safety Set consisted of subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in Calgary Depression Scale for Schizophrenia (CDSS) Total Score at Day 5: 70 mg | -0.4 units on a scale | Standard Error 0.3 |
| SPD489 (Lisdexamfetamine Dimesylate)(50 mg) | Change From Baseline in Calgary Depression Scale for Schizophrenia (CDSS) Total Score at Day 5: 70 mg | -0.7 units on a scale | Standard Error 0.28 |
Secondary
Change From Baseline in Cognitive Test Battery (CogState Battery) Score at Day 5: Detection Task, 100 mg
This battery is a series of 4 computerized cognition tests (Groton Maze Learning Test, Detection Task, Identification Task, and One Card Learning Task) designed to measure reaction time, visual learning and reasoning, and problem solving. The entire battery takes approximately 12 minutes to complete. CogState scores are measured on a linear scale (no maximum score). The Groton Maze Learning Test measures total number of errors made in problem solving (lower score = better performance). The Detection Task is measured by speed of performance (lower score = better performance). The Identification Task is measured by speed of performance (lower score = better performance). One Card Learning Task measures the accuracy of performance (higher score = better performance).
Time frame: Baseline and Day 5
Population: Safety Set consisted of subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in Cognitive Test Battery (CogState Battery) Score at Day 5: Detection Task, 100 mg | 0.014 Log10 milliseconds | Standard Error 0.0492 |
| SPD489 (Lisdexamfetamine Dimesylate)(50 mg) | Change From Baseline in Cognitive Test Battery (CogState Battery) Score at Day 5: Detection Task, 100 mg | -0.047 Log10 milliseconds | Standard Error 0.0246 |
Secondary
Change From Baseline in Cognitive Test Battery (CogState Battery) Score at Day 5: Detection Task, 150 mg
This battery is a series of 4 computerized cognition tests (Groton Maze Learning Test, Detection Task, Identification Task, and One Card Learning Task) designed to measure reaction time, visual learning and reasoning, and problem solving. The entire battery takes approximately 12 minutes to complete. CogState scores are measured on a linear scale (no maximum score). The Groton Maze Learning Test measures total number of errors made in problem solving (lower score = better performance). The Detection Task is measured by speed of performance (lower score = better performance). The Identification Task is measured by speed of performance (lower score = better performance). One Card Learning Task measures the accuracy of performance (higher score = better performance).
Time frame: Baseline and Day 5
Population: Safety Set consisted of subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in Cognitive Test Battery (CogState Battery) Score at Day 5: Detection Task, 150 mg | 0.037 Log10 milliseconds | Standard Error 0.0373 |
| SPD489 (Lisdexamfetamine Dimesylate)(50 mg) | Change From Baseline in Cognitive Test Battery (CogState Battery) Score at Day 5: Detection Task, 150 mg | -0.039 Log10 milliseconds | Standard Error 0.018 |
Secondary
Change From Baseline in Cognitive Test Battery (CogState Battery) Score at Day 5: Detection Task, 200 mg
This battery is a series of 4 computerized cognition tests (Groton Maze Learning Test, Detection Task, Identification Task, and One Card Learning Task) designed to measure reaction time, visual learning and reasoning, and problem solving. The entire battery takes approximately 12 minutes to complete. CogState scores are measured on a linear scale (no maximum score). The Groton Maze Learning Test measures total number of errors made in problem solving (lower score = better performance). The Detection Task is measured by speed of performance (lower score = better performance). The Identification Task is measured by speed of performance (lower score = better performance). One Card Learning Task measures the accuracy of performance (higher score = better performance).
Time frame: Baseline and Day 5
Population: Safety Set consisted of subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in Cognitive Test Battery (CogState Battery) Score at Day 5: Detection Task, 200 mg | -0.025 Log10 milliseconds | Standard Error 0.0395 |
| SPD489 (Lisdexamfetamine Dimesylate)(50 mg) | Change From Baseline in Cognitive Test Battery (CogState Battery) Score at Day 5: Detection Task, 200 mg | -0.049 Log10 milliseconds | Standard Error 0.0178 |
Secondary
Change From Baseline in Cognitive Test Battery (CogState Battery) Score at Day 5: Detection Task, 250 mg
This battery is a series of 4 computerized cognition tests (Groton Maze Learning Test, Detection Task, Identification Task, and One Card Learning Task) designed to measure reaction time, visual learning and reasoning, and problem solving. The entire battery takes approximately 12 minutes to complete. CogState scores are measured on a linear scale (no maximum score). The Groton Maze Learning Test measures total number of errors made in problem solving (lower score = better performance). The Detection Task is measured by speed of performance (lower score = better performance). The Identification Task is measured by speed of performance (lower score = better performance). One Card Learning Task measures the accuracy of performance (higher score = better performance).
Time frame: Baseline and Day 5
Population: Safety Set consisted of subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in Cognitive Test Battery (CogState Battery) Score at Day 5: Detection Task, 250 mg | -0.034 Log10 milliseconds | Standard Error 0.0581 |
| SPD489 (Lisdexamfetamine Dimesylate)(50 mg) | Change From Baseline in Cognitive Test Battery (CogState Battery) Score at Day 5: Detection Task, 250 mg | -0.048 Log10 milliseconds | Standard Error 0.0147 |
Secondary
Change From Baseline in Cognitive Test Battery (CogState Battery) Score at Day 5: Detection Task, 50 mg
This battery is a series of 4 computerized cognition tests (Groton Maze Learning Test, Detection Task, Identification Task, and One Card Learning Task) designed to measure reaction time, visual learning and reasoning, and problem solving. The entire battery takes approximately 12 minutes to complete. CogState scores are measured on a linear scale (no maximum score). The Groton Maze Learning Test measures total number of errors made in problem solving (lower score = better performance). The Detection Task is measured by speed of performance (lower score = better performance). The Identification Task is measured by speed of performance (lower score = better performance). One Card Learning Task measures the accuracy of performance (higher score = better performance).
Time frame: Baseline and Day 5
Population: Safety Set consisted of subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in Cognitive Test Battery (CogState Battery) Score at Day 5: Detection Task, 50 mg | 0.0 Log10 milliseconds | Standard Error 0.0389 |
| SPD489 (Lisdexamfetamine Dimesylate)(50 mg) | Change From Baseline in Cognitive Test Battery (CogState Battery) Score at Day 5: Detection Task, 50 mg | -0.034 Log10 milliseconds | Standard Error 0.0223 |
Secondary
Change From Baseline in Cognitive Test Battery (CogState Battery) Score at Day 5: Detection Task, 70 mg
This battery is a series of 4 computerized cognition tests (Groton Maze Learning Test, Detection Task, Identification Task, and One Card Learning Task) designed to measure reaction time, visual learning and reasoning, and problem solving. The entire battery takes approximately 12 minutes to complete. CogState scores are measured on a linear scale (no maximum score). The Groton Maze Learning Test measures total number of errors made in problem solving (lower score = better performance). The Detection Task is measured by speed of performance (lower score = better performance). The Identification Task is measured by speed of performance (lower score = better performance). One Card Learning Task measures the accuracy of performance (higher score = better performance).
Time frame: Baseline and Day 5
Population: Safety Set consisted of subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in Cognitive Test Battery (CogState Battery) Score at Day 5: Detection Task, 70 mg | 0.017 Log10 milliseconds | Standard Error 0.0411 |
| SPD489 (Lisdexamfetamine Dimesylate)(50 mg) | Change From Baseline in Cognitive Test Battery (CogState Battery) Score at Day 5: Detection Task, 70 mg | -0.015 Log10 milliseconds | Standard Error 0.0195 |
Secondary
Change From Baseline in Cognitive Test Battery (CogState Battery) Score at Day 5: Groton Maze Learning Test, 100 mg
This battery is a series of 4 computerized cognition tests (Groton Maze Learning Test, Detection Task, Identification Task, and One Card Learning Task) designed to measure reaction time, visual learning and reasoning, and problem solving. The entire battery takes approximately 12 minutes to complete. CogState scores are measured on a linear scale (no maximum score). The Groton Maze Learning Test measures total number of errors made in problem solving (lower score = better performance). The Detection Task is measured by speed of performance (lower score = better performance). The Identification Task is measured by speed of performance (lower score = better performance). One Card Learning Task measures the accuracy of performance (higher score = better performance).
Time frame: Baseline and Day 5
Population: Safety Set consisted of subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in Cognitive Test Battery (CogState Battery) Score at Day 5: Groton Maze Learning Test, 100 mg | 0.9 Number of Errors | Standard Error 9.55 |
| SPD489 (Lisdexamfetamine Dimesylate)(50 mg) | Change From Baseline in Cognitive Test Battery (CogState Battery) Score at Day 5: Groton Maze Learning Test, 100 mg | -15.7 Number of Errors | Standard Error 6.57 |
Secondary
Change From Baseline in Cognitive Test Battery (CogState Battery) Score at Day 5: Groton Maze Learning Test, 150 mg
This battery is a series of 4 computerized cognition tests (Groton Maze Learning Test, Detection Task, Identification Task, and One Card Learning Task) designed to measure reaction time, visual learning and reasoning, and problem solving. The entire battery takes approximately 12 minutes to complete. CogState scores are measured on a linear scale (no maximum score). The Groton Maze Learning Test measures total number of errors made in problem solving (lower score = better performance). The Detection Task is measured by speed of performance (lower score = better performance). The Identification Task is measured by speed of performance (lower score = better performance). One Card Learning Task measures the accuracy of performance (higher score = better performance).
Time frame: Baseline and Day 5
Population: Safety Set consisted of subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in Cognitive Test Battery (CogState Battery) Score at Day 5: Groton Maze Learning Test, 150 mg | 21.1 Number of Errors | Standard Error 28.75 |
| SPD489 (Lisdexamfetamine Dimesylate)(50 mg) | Change From Baseline in Cognitive Test Battery (CogState Battery) Score at Day 5: Groton Maze Learning Test, 150 mg | -11.3 Number of Errors | Standard Error 6.26 |
Secondary
Change From Baseline in Cognitive Test Battery (CogState Battery) Score at Day 5: Groton Maze Learning Test, 200 mg
This battery is a series of 4 computerized cognition tests (Groton Maze Learning Test, Detection Task, Identification Task, and One Card Learning Task) designed to measure reaction time, visual learning and reasoning, and problem solving. The entire battery takes approximately 12 minutes to complete. CogState scores are measured on a linear scale (no maximum score). The Groton Maze Learning Test measures total number of errors made in problem solving (lower score = better performance). The Detection Task is measured by speed of performance (lower score = better performance). The Identification Task is measured by speed of performance (lower score = better performance). One Card Learning Task measures the accuracy of performance (higher score = better performance).
Time frame: Baseline and Day 5
Population: Safety Set consisted of subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in Cognitive Test Battery (CogState Battery) Score at Day 5: Groton Maze Learning Test, 200 mg | -10.3 Number of Errors | Standard Error 6.3 |
| SPD489 (Lisdexamfetamine Dimesylate)(50 mg) | Change From Baseline in Cognitive Test Battery (CogState Battery) Score at Day 5: Groton Maze Learning Test, 200 mg | -16.5 Number of Errors | Standard Error 6.65 |
Secondary
Change From Baseline in Cognitive Test Battery (CogState Battery) Score at Day 5: Groton Maze Learning Test, 250 mg
This battery is a series of 4 computerized cognition tests (Groton Maze Learning Test, Detection Task, Identification Task, and One Card Learning Task) designed to measure reaction time, visual learning and reasoning, and problem solving. The entire battery takes approximately 12 minutes to complete. CogState scores are measured on a linear scale (no maximum score). The Groton Maze Learning Test measures total number of errors made in problem solving (lower score = better performance). The Detection Task is measured by speed of performance (lower score = better performance). The Identification Task is measured by speed of performance (lower score = better performance). One Card Learning Task measures the accuracy of performance (higher score = better performance).
Time frame: Baseline and Day 5
Population: Safety Set consisted of subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in Cognitive Test Battery (CogState Battery) Score at Day 5: Groton Maze Learning Test, 250 mg | -5.0 Number of Errors | Standard Error 8.74 |
| SPD489 (Lisdexamfetamine Dimesylate)(50 mg) | Change From Baseline in Cognitive Test Battery (CogState Battery) Score at Day 5: Groton Maze Learning Test, 250 mg | -13.2 Number of Errors | Standard Error 5.25 |
Secondary
Change From Baseline in Cognitive Test Battery (CogState Battery) Score at Day 5: Groton Maze Learning Test, 50 mg
This battery is a series of 4 computerized cognition tests (Groton Maze Learning Test, Detection Task, Identification Task, and One Card Learning Task) designed to measure reaction time, visual learning and reasoning, and problem solving. The entire battery takes approximately 12 minutes to complete. CogState scores are measured on a linear scale (no maximum score). The Groton Maze Learning Test measures total number of errors made in problem solving (lower score = better performance). The Detection Task is measured by speed of performance (lower score = better performance). The Identification Task is measured by speed of performance (lower score = better performance). One Card Learning Task measures the accuracy of performance (higher score = better performance).
Time frame: Baseline and Day 5
Population: Safety Set consisted of subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in Cognitive Test Battery (CogState Battery) Score at Day 5: Groton Maze Learning Test, 50 mg | -0.9 Number of Errors | Standard Error 8.02 |
| SPD489 (Lisdexamfetamine Dimesylate)(50 mg) | Change From Baseline in Cognitive Test Battery (CogState Battery) Score at Day 5: Groton Maze Learning Test, 50 mg | -8.2 Number of Errors | Standard Error 5.79 |
Secondary
Change From Baseline in Cognitive Test Battery (CogState Battery) Score at Day 5: Groton Maze Learning Test, 70 mg
This battery is a series of 4 computerized cognition tests (Groton Maze Learning Test, Detection Task, Identification Task, and One Card Learning Task) designed to measure reaction time, visual learning and reasoning, and problem solving. The entire battery takes approximately 12 minutes to complete. CogState scores are measured on a linear scale (no maximum score). The Groton Maze Learning Test measures total number of errors made in problem solving (lower score = better performance). The Detection Task is measured by speed of performance (lower score = better performance). The Identification Task is measured by speed of performance (lower score = better performance). One Card Learning Task measures the accuracy of performance (higher score = better performance).
Time frame: Baseline and Day 5
Population: Safety Set consisted of subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in Cognitive Test Battery (CogState Battery) Score at Day 5: Groton Maze Learning Test, 70 mg | 8.7 Number of Errors | Standard Error 10.77 |
| SPD489 (Lisdexamfetamine Dimesylate)(50 mg) | Change From Baseline in Cognitive Test Battery (CogState Battery) Score at Day 5: Groton Maze Learning Test, 70 mg | -7.3 Number of Errors | Standard Error 6.45 |
Secondary
Change From Baseline in Cognitive Test Battery (CogState Battery) Score at Day 5: Identification Task, 100 mg
This battery is a series of 4 computerized cognition tests (Groton Maze Learning Test, Detection Task, Identification Task, and One Card Learning Task) designed to measure reaction time, visual learning and reasoning, and problem solving. The entire battery takes approximately 12 minutes to complete. CogState scores are measured on a linear scale (no maximum score). The Groton Maze Learning Test measures total number of errors made in problem solving (lower score = better performance). The Detection Task is measured by speed of performance (lower score = better performance). The Identification Task is measured by speed of performance (lower score = better performance). One Card Learning Task measures the accuracy of performance (higher score = better performance).
Time frame: Baseline and Day 5
Population: Safety Set consisted of subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in Cognitive Test Battery (CogState Battery) Score at Day 5: Identification Task, 100 mg | 0.011 Log10 milliseconds | Standard Error 0.0348 |
| SPD489 (Lisdexamfetamine Dimesylate)(50 mg) | Change From Baseline in Cognitive Test Battery (CogState Battery) Score at Day 5: Identification Task, 100 mg | 0.001 Log10 milliseconds | Standard Error 0.0171 |
Secondary
Change From Baseline in Cognitive Test Battery (CogState Battery) Score at Day 5: Identification Task, 150 mg
This battery is a series of 4 computerized cognition tests (Groton Maze Learning Test, Detection Task, Identification Task, and One Card Learning Task) designed to measure reaction time, visual learning and reasoning, and problem solving. The entire battery takes approximately 12 minutes to complete. CogState scores are measured on a linear scale (no maximum score). The Groton Maze Learning Test measures total number of errors made in problem solving (lower score = better performance). The Detection Task is measured by speed of performance (lower score = better performance). The Identification Task is measured by speed of performance (lower score = better performance). One Card Learning Task measures the accuracy of performance (higher score = better performance).
Time frame: Baseline and Day 5
Population: Safety Set consisted of subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in Cognitive Test Battery (CogState Battery) Score at Day 5: Identification Task, 150 mg | 0.036 Log10 milliseconds | Standard Error 0.0419 |
| SPD489 (Lisdexamfetamine Dimesylate)(50 mg) | Change From Baseline in Cognitive Test Battery (CogState Battery) Score at Day 5: Identification Task, 150 mg | -0.010 Log10 milliseconds | Standard Error 0.0172 |
Secondary
Change From Baseline in Cognitive Test Battery (CogState Battery) Score at Day 5: Identification Task, 200 mg
This battery is a series of 4 computerized cognition tests (Groton Maze Learning Test, Detection Task, Identification Task, and One Card Learning Task) designed to measure reaction time, visual learning and reasoning, and problem solving. The entire battery takes approximately 12 minutes to complete. CogState scores are measured on a linear scale (no maximum score). The Groton Maze Learning Test measures total number of errors made in problem solving (lower score = better performance). The Detection Task is measured by speed of performance (lower score = better performance). The Identification Task is measured by speed of performance (lower score = better performance). One Card Learning Task measures the accuracy of performance (higher score = better performance).
Time frame: Baseline and Day 5
Population: Safety Set consisted of subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in Cognitive Test Battery (CogState Battery) Score at Day 5: Identification Task, 200 mg | 0.044 Log10 milliseconds | Standard Error 0.0397 |
| SPD489 (Lisdexamfetamine Dimesylate)(50 mg) | Change From Baseline in Cognitive Test Battery (CogState Battery) Score at Day 5: Identification Task, 200 mg | -0.014 Log10 milliseconds | Standard Error 0.0157 |
Secondary
Change From Baseline in Cognitive Test Battery (CogState Battery) Score at Day 5: Identification Task, 250 mg
This battery is a series of 4 computerized cognition tests (Groton Maze Learning Test, Detection Task, Identification Task, and One Card Learning Task) designed to measure reaction time, visual learning and reasoning, and problem solving. The entire battery takes approximately 12 minutes to complete. CogState scores are measured on a linear scale (no maximum score). The Groton Maze Learning Test measures total number of errors made in problem solving (lower score = better performance). The Detection Task is measured by speed of performance (lower score = better performance). The Identification Task is measured by speed of performance (lower score = better performance). One Card Learning Task measures the accuracy of performance (higher score = better performance).
Time frame: Baseline and Day 5
Population: Safety Set consisted of subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in Cognitive Test Battery (CogState Battery) Score at Day 5: Identification Task, 250 mg | 0.005 Log10 milliseconds | Standard Error 0.0531 |
| SPD489 (Lisdexamfetamine Dimesylate)(50 mg) | Change From Baseline in Cognitive Test Battery (CogState Battery) Score at Day 5: Identification Task, 250 mg | -0.007 Log10 milliseconds | Standard Error 0.0144 |
Secondary
Change From Baseline in Cognitive Test Battery (CogState Battery) Score at Day 5: Identification Task, 50 mg
This battery is a series of 4 computerized cognition tests (Groton Maze Learning Test, Detection Task, Identification Task, and One Card Learning Task) designed to measure reaction time, visual learning and reasoning, and problem solving. The entire battery takes approximately 12 minutes to complete. CogState scores are measured on a linear scale (no maximum score). The Groton Maze Learning Test measures total number of errors made in problem solving (lower score = better performance). The Detection Task is measured by speed of performance (lower score = better performance). The Identification Task is measured by speed of performance (lower score = better performance). One Card Learning Task measures the accuracy of performance (higher score = better performance).
Time frame: Baseline and Day 5
Population: Safety Set consisted of subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in Cognitive Test Battery (CogState Battery) Score at Day 5: Identification Task, 50 mg | 0.028 Log10 milliseconds | Standard Error 0.0304 |
| SPD489 (Lisdexamfetamine Dimesylate)(50 mg) | Change From Baseline in Cognitive Test Battery (CogState Battery) Score at Day 5: Identification Task, 50 mg | 0.001 Log10 milliseconds | Standard Error 0.0141 |
Secondary
Change From Baseline in Cognitive Test Battery (CogState Battery) Score at Day 5: Identification Task, 70 mg
This battery is a series of 4 computerized cognition tests (Groton Maze Learning Test, Detection Task, Identification Task, and One Card Learning Task) designed to measure reaction time, visual learning and reasoning, and problem solving. The entire battery takes approximately 12 minutes to complete. CogState scores are measured on a linear scale (no maximum score). The Groton Maze Learning Test measures total number of errors made in problem solving (lower score = better performance). The Detection Task is measured by speed of performance (lower score = better performance). The Identification Task is measured by speed of performance (lower score = better performance). One Card Learning Task measures the accuracy of performance (higher score = better performance).
Time frame: Baseline and Day 5
Population: Safety Set consisted of subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in Cognitive Test Battery (CogState Battery) Score at Day 5: Identification Task, 70 mg | 0.015 Log10 milliseconds | Standard Error 0.0273 |
| SPD489 (Lisdexamfetamine Dimesylate)(50 mg) | Change From Baseline in Cognitive Test Battery (CogState Battery) Score at Day 5: Identification Task, 70 mg | 0.006 Log10 milliseconds | Standard Error 0.0113 |
Secondary
Change From Baseline in Cognitive Test Battery (CogState Battery) Score at Day 5: One Card Learning Task, 100 mg
This battery is a series of 4 computerized cognition tests (Groton Maze Learning Test, Detection Task, Identification Task, and One Card Learning Task) designed to measure reaction time, visual learning and reasoning, and problem solving. The entire battery takes approximately 12 minutes to complete. CogState scores are measured on a linear scale (no maximum score). The Groton Maze Learning Test measures total number of errors made in problem solving (lower score = better performance). The Detection Task is measured by speed of performance (lower score = better performance). The Identification Task is measured by speed of performance (lower score = better performance). One Card Learning Task measures the accuracy of performance (higher score = better performance).
Time frame: Baseline and Day 5
Population: Safety Set consisted of subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in Cognitive Test Battery (CogState Battery) Score at Day 5: One Card Learning Task, 100 mg | 0.012 Arcsine proportion correct | Standard Error 0.0373 |
| SPD489 (Lisdexamfetamine Dimesylate)(50 mg) | Change From Baseline in Cognitive Test Battery (CogState Battery) Score at Day 5: One Card Learning Task, 100 mg | 0.012 Arcsine proportion correct | Standard Error 0.0197 |
Secondary
Change From Baseline in Cognitive Test Battery (CogState Battery) Score at Day 5: One Card Learning Task, 150 mg
This battery is a series of 4 computerized cognition tests (Groton Maze Learning Test, Detection Task, Identification Task, and One Card Learning Task) designed to measure reaction time, visual learning and reasoning, and problem solving. The entire battery takes approximately 12 minutes to complete. CogState scores are measured on a linear scale (no maximum score). The Groton Maze Learning Test measures total number of errors made in problem solving (lower score = better performance). The Detection Task is measured by speed of performance (lower score = better performance). The Identification Task is measured by speed of performance (lower score = better performance). One Card Learning Task measures the accuracy of performance (higher score = better performance).
Time frame: Baseline and Day 5
Population: Safety Set consisted of subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in Cognitive Test Battery (CogState Battery) Score at Day 5: One Card Learning Task, 150 mg | 0.026 Arcsine proportion correct | Standard Error 0.0415 |
| SPD489 (Lisdexamfetamine Dimesylate)(50 mg) | Change From Baseline in Cognitive Test Battery (CogState Battery) Score at Day 5: One Card Learning Task, 150 mg | 0.042 Arcsine proportion correct | Standard Error 0.0222 |
Secondary
Change From Baseline in Cognitive Test Battery (CogState Battery) Score at Day 5: One Card Learning Task, 200 mg
This battery is a series of 4 computerized cognition tests (Groton Maze Learning Test, Detection Task, Identification Task, and One Card Learning Task) designed to measure reaction time, visual learning and reasoning, and problem solving. The entire battery takes approximately 12 minutes to complete. CogState scores are measured on a linear scale (no maximum score). The Groton Maze Learning Test measures total number of errors made in problem solving (lower score = better performance). The Detection Task is measured by speed of performance (lower score = better performance). The Identification Task is measured by speed of performance (lower score = better performance). One Card Learning Task measures the accuracy of performance (higher score = better performance).
Time frame: Baseline and Day 5
Population: Safety Set consisted of subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in Cognitive Test Battery (CogState Battery) Score at Day 5: One Card Learning Task, 200 mg | -0.020 Arcsine proportion correct | Standard Error 0.0394 |
| SPD489 (Lisdexamfetamine Dimesylate)(50 mg) | Change From Baseline in Cognitive Test Battery (CogState Battery) Score at Day 5: One Card Learning Task, 200 mg | 0.046 Arcsine proportion correct | Standard Error 0.0219 |
Secondary
Change From Baseline in Cognitive Test Battery (CogState Battery) Score at Day 5: One Card Learning Task, 250 mg
This battery is a series of 4 computerized cognition tests (Groton Maze Learning Test, Detection Task, Identification Task, and One Card Learning Task) designed to measure reaction time, visual learning and reasoning, and problem solving. The entire battery takes approximately 12 minutes to complete. CogState scores are measured on a linear scale (no maximum score). The Groton Maze Learning Test measures total number of errors made in problem solving (lower score = better performance). The Detection Task is measured by speed of performance (lower score = better performance). The Identification Task is measured by speed of performance (lower score = better performance). One Card Learning Task measures the accuracy of performance (higher score = better performance).
Time frame: Baseline and Day 5
Population: Safety Set consisted of subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in Cognitive Test Battery (CogState Battery) Score at Day 5: One Card Learning Task, 250 mg | 0.018 Arcsine proportion correct | Standard Error 0.0432 |
| SPD489 (Lisdexamfetamine Dimesylate)(50 mg) | Change From Baseline in Cognitive Test Battery (CogState Battery) Score at Day 5: One Card Learning Task, 250 mg | 0.022 Arcsine proportion correct | Standard Error 0.025 |
Secondary
Change From Baseline in Cognitive Test Battery (CogState Battery) Score at Day 5: One Card Learning Task, 50 mg
This battery is a series of 4 computerized cognition tests (Groton Maze Learning Test, Detection Task, Identification Task, and One Card Learning Task) designed to measure reaction time, visual learning and reasoning, and problem solving. The entire battery takes approximately 12 minutes to complete. CogState scores are measured on a linear scale (no maximum score). The Groton Maze Learning Test measures total number of errors made in problem solving (lower score = better performance). The Detection Task is measured by speed of performance (lower score = better performance). The Identification Task is measured by speed of performance (lower score = better performance). One Card Learning Task measures the accuracy of performance (higher score = better performance).
Time frame: Baseline and Day 5
Population: Safety Set consisted of subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in Cognitive Test Battery (CogState Battery) Score at Day 5: One Card Learning Task, 50 mg | 0.025 Arcsine proportion correct | Standard Error 0.0234 |
| SPD489 (Lisdexamfetamine Dimesylate)(50 mg) | Change From Baseline in Cognitive Test Battery (CogState Battery) Score at Day 5: One Card Learning Task, 50 mg | 0.005 Arcsine proportion correct | Standard Error 0.0179 |
Secondary
Change From Baseline in Cognitive Test Battery (CogState Battery) Score at Day 5: One Card Learning Task, 70 mg
This battery is a series of 4 computerized cognition tests (Groton Maze Learning Test, Detection Task, Identification Task, and One Card Learning Task) designed to measure reaction time, visual learning and reasoning, and problem solving. The entire battery takes approximately 12 minutes to complete. CogState scores are measured on a linear scale (no maximum score). The Groton Maze Learning Test measures total number of errors made in problem solving (lower score = better performance). The Detection Task is measured by speed of performance (lower score = better performance). The Identification Task is measured by speed of performance (lower score = better performance). One Card Learning Task measures the accuracy of performance (higher score = better performance).
Time frame: Baseline and Day 5
Population: Safety Set consisted of subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in Cognitive Test Battery (CogState Battery) Score at Day 5: One Card Learning Task, 70 mg | 0.015 Arcsine proportion correct | Standard Error 0.0322 |
| SPD489 (Lisdexamfetamine Dimesylate)(50 mg) | Change From Baseline in Cognitive Test Battery (CogState Battery) Score at Day 5: One Card Learning Task, 70 mg | 0.021 Arcsine proportion correct | Standard Error 0.0189 |
Secondary
Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score at Day 5: 100 mg
The PANSS is a validated measure that evaluates the presence, absence, and severity of 30 symptoms of schizophrenia including both positive and negative symptoms and general psychopathology. Each of the 30-items are rated on a scale of 1 (absent) to 7 (extreme) with a total scoring range of 30 to 210. Higher scores indicate more impairment.
Time frame: Baseline and Day 5
Population: Safety Set consisted of subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score at Day 5: 100 mg | -3.6 units on a scale | Standard Error 1.43 |
| SPD489 (Lisdexamfetamine Dimesylate)(50 mg) | Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score at Day 5: 100 mg | -3.9 units on a scale | Standard Error 1.68 |
Secondary
Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score at Day 5: 150 mg
The PANSS is a validated measure that evaluates the presence, absence, and severity of 30 symptoms of schizophrenia including both positive and negative symptoms and general psychopathology. Each of the 30-items are rated on a scale of 1 (absent) to 7 (extreme) with a total scoring range of 30 to 210. Higher scores indicate more impairment.
Time frame: Baseline and Day 5
Population: Safety Set consisted of subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score at Day 5: 150 mg | -2.1 units on a scale | Standard Error 1.4 |
| SPD489 (Lisdexamfetamine Dimesylate)(50 mg) | Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score at Day 5: 150 mg | -4.7 units on a scale | Standard Error 1.44 |
Secondary
Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score at Day 5: 200 mg
The PANSS is a validated measure that evaluates the presence, absence, and severity of 30 symptoms of schizophrenia including both positive and negative symptoms and general psychopathology. Each of the 30-items are rated on a scale of 1 (absent) to 7 (extreme) with a total scoring range of 30 to 210. Higher scores indicate more impairment.
Time frame: Baseline and Day 5
Population: Safety Set consisted of subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score at Day 5: 200 mg | -2.3 units on a scale | Standard Error 2.01 |
| SPD489 (Lisdexamfetamine Dimesylate)(50 mg) | Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score at Day 5: 200 mg | -4.6 units on a scale | Standard Error 1.81 |
Secondary
Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score at Day 5: 250 mg
The PANSS is a validated measure that evaluates the presence, absence, and severity of 30 symptoms of schizophrenia including both positive and negative symptoms and general psychopathology. Each of the 30-items are rated on a scale of 1 (absent) to 7 (extreme) with a total scoring range of 30 to 210. Higher scores indicate more impairment.
Time frame: Baseline and Day 5
Population: Safety Set consisted of subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score at Day 5: 250 mg | -2.3 units on a scale | Standard Error 2.03 |
| SPD489 (Lisdexamfetamine Dimesylate)(50 mg) | Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score at Day 5: 250 mg | -2.4 units on a scale | Standard Error 2.01 |
Secondary
Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score at Day 5: 50 mg
The PANSS is a validated measure that evaluates the presence, absence, and severity of 30 symptoms of schizophrenia including both positive and negative symptoms and general psychopathology. Each of the 30-items are rated on a scale of 1 (absent) to 7 (extreme) with a total scoring range of 30 to 210. Higher scores indicate more impairment.
Time frame: Baseline and Day 5
Population: Safety Set consisted of subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score at Day 5: 50 mg | 0.6 units on a scale | Standard Error 2.22 |
| SPD489 (Lisdexamfetamine Dimesylate)(50 mg) | Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score at Day 5: 50 mg | -1.9 units on a scale | Standard Error 1.1 |
Secondary
Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score at Day 5: 70 mg
The PANSS is a validated measure that evaluates the presence, absence, and severity of 30 symptoms of schizophrenia including both positive and negative symptoms and general psychopathology. Each of the 30-items are rated on a scale of 1 (absent) to 7 (extreme) with a total scoring range of 30 to 210. Higher scores indicate more impairment.
Time frame: Baseline and Day 5
Population: Safety Set consisted of subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score at Day 5: 70 mg | -2.1 units on a scale | Standard Error 1.81 |
| SPD489 (Lisdexamfetamine Dimesylate)(50 mg) | Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score at Day 5: 70 mg | -2.9 units on a scale | Standard Error 1.5 |
Secondary
Change From Baseline in Scale for the Assessment of Negative Symptoms (SANS-18) Total Score at Day 5: 100 mg
The SANS was modified by eliminating the global and attention items; the score of the remaining non-global items is referred to as the SANS-18 total score. Each of the 18-items is scored on a scale from 0 (not at all) to 5 (severe) with a total scoring range of 0 to 90. Higher scores indicate more impairment.
Time frame: Baseline and Day 5
Population: Safety Set consisted of subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in Scale for the Assessment of Negative Symptoms (SANS-18) Total Score at Day 5: 100 mg | -7.0 units on a scale | Standard Error 3.07 |
| SPD489 (Lisdexamfetamine Dimesylate)(50 mg) | Change From Baseline in Scale for the Assessment of Negative Symptoms (SANS-18) Total Score at Day 5: 100 mg | -2.6 units on a scale | Standard Error 1.27 |
Secondary
Change From Baseline in Scale for the Assessment of Negative Symptoms (SANS-18) Total Score at Day 5: 150 mg
The SANS was modified by eliminating the global and attention items; the score of the remaining non-global items is referred to as the SANS-18 total score. Each of the 18-items is scored on a scale from 0 (not at all) to 5 (severe) with a total scoring range of 0 to 90. Higher scores indicate more impairment.
Time frame: Baseline and Day 5
Population: Safety Set consisted of subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in Scale for the Assessment of Negative Symptoms (SANS-18) Total Score at Day 5: 150 mg | -4.0 units on a scale | Standard Error 3.24 |
| SPD489 (Lisdexamfetamine Dimesylate)(50 mg) | Change From Baseline in Scale for the Assessment of Negative Symptoms (SANS-18) Total Score at Day 5: 150 mg | -3.0 units on a scale | Standard Error 1.17 |
Secondary
Change From Baseline in Scale for the Assessment of Negative Symptoms (SANS-18) Total Score at Day 5: 200 mg
The SANS was modified by eliminating the global and attention items; the score of the remaining non-global items is referred to as the SANS-18 total score. Each of the 18-items is scored on a scale from 0 (not at all) to 5 (severe) with a total scoring range of 0 to 90. Higher scores indicate more impairment.
Time frame: Baseline and Day 5
Population: Safety Set consisted of subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in Scale for the Assessment of Negative Symptoms (SANS-18) Total Score at Day 5: 200 mg | 1.3 units on a scale | Standard Error 3.75 |
| SPD489 (Lisdexamfetamine Dimesylate)(50 mg) | Change From Baseline in Scale for the Assessment of Negative Symptoms (SANS-18) Total Score at Day 5: 200 mg | -2.6 units on a scale | Standard Error 1.11 |
Secondary
Change From Baseline in Scale for the Assessment of Negative Symptoms (SANS-18) Total Score at Day 5: 250 mg
The SANS was modified by eliminating the global and attention items; the score of the remaining non-global items is referred to as the SANS-18 total score. Each of the 18-items is scored on a scale from 0 (not at all) to 5 (severe) with a total scoring range of 0 to 90. Higher scores indicate more impairment.
Time frame: Baseline and Day 5
Population: Safety Set consisted of subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in Scale for the Assessment of Negative Symptoms (SANS-18) Total Score at Day 5: 250 mg | -4.2 units on a scale | Standard Error 2.15 |
| SPD489 (Lisdexamfetamine Dimesylate)(50 mg) | Change From Baseline in Scale for the Assessment of Negative Symptoms (SANS-18) Total Score at Day 5: 250 mg | -3.3 units on a scale | Standard Error 1.47 |
Secondary
Change From Baseline in Scale for the Assessment of Negative Symptoms (SANS-18) Total Score at Day 5: 50 mg
The SANS was modified by eliminating the global and attention items; the score of the remaining non-global items is referred to as the SANS-18 total score. Each of the 18-items is scored on a scale from 0 (not at all) to 5 (severe) with a total scoring range of 0 to 90. Higher scores indicate more impairment.
Time frame: Baseline and Day 5
Population: Safety Set consisted of subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in Scale for the Assessment of Negative Symptoms (SANS-18) Total Score at Day 5: 50 mg | -1.4 units on a scale | Standard Error 1.54 |
| SPD489 (Lisdexamfetamine Dimesylate)(50 mg) | Change From Baseline in Scale for the Assessment of Negative Symptoms (SANS-18) Total Score at Day 5: 50 mg | -1.7 units on a scale | Standard Error 1.09 |
Secondary
Change From Baseline in Scale for the Assessment of Negative Symptoms (SANS-18) Total Score at Day 5: 70 mg
The SANS was modified by eliminating the global and attention items; the score of the remaining non-global items is referred to as the SANS-18 total score. Each of the 18-items is scored on a scale from 0 (not at all) to 5 (severe) with a total scoring range of 0 to 90. Higher scores indicate more impairment.
Time frame: Baseline and Day 5
Population: Safety Set consisted of subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in Scale for the Assessment of Negative Symptoms (SANS-18) Total Score at Day 5: 70 mg | -3.0 units on a scale | Standard Error 2.85 |
| SPD489 (Lisdexamfetamine Dimesylate)(50 mg) | Change From Baseline in Scale for the Assessment of Negative Symptoms (SANS-18) Total Score at Day 5: 70 mg | -3.1 units on a scale | Standard Error 1.15 |
Secondary
Change From Baseline in Simpson Angus Scale (SAS) Total Score at Day 5: 100 mg
SAS is a 10-item scale used to evaluate the presence and severity of extrapyramidal symptoms. The items are scored on a scale from 0 to 4 with item-specific definitions given for each point. Total scores range from 0 to 40. Lower scores indicate less impairment.
Time frame: Baseline and Day 5
Population: Safety Set consisted of subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in Simpson Angus Scale (SAS) Total Score at Day 5: 100 mg | -0.4 units on a scale | Standard Error 0.48 |
| SPD489 (Lisdexamfetamine Dimesylate)(50 mg) | Change From Baseline in Simpson Angus Scale (SAS) Total Score at Day 5: 100 mg | 0.0 units on a scale | Standard Error 0.21 |
Secondary
Change From Baseline in Simpson Angus Scale (SAS) Total Score at Day 5: 150 mg
SAS is a 10-item scale used to evaluate the presence and severity of extrapyramidal symptoms. The items are scored on a scale from 0 to 4 with item-specific definitions given for each point. Total scores range from 0 to 40. Lower scores indicate less impairment.
Time frame: Baseline and Day 5
Population: Safety Set consisted of subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in Simpson Angus Scale (SAS) Total Score at Day 5: 150 mg | -0.3 units on a scale | Standard Error 0.29 |
| SPD489 (Lisdexamfetamine Dimesylate)(50 mg) | Change From Baseline in Simpson Angus Scale (SAS) Total Score at Day 5: 150 mg | 0.1 units on a scale | Standard Error 0.19 |
Secondary
Change From Baseline in Simpson Angus Scale (SAS) Total Score at Day 5: 200 mg
SAS is a 10-item scale used to evaluate the presence and severity of extrapyramidal symptoms. The items are scored on a scale from 0 to 4 with item-specific definitions given for each point. Total scores range from 0 to 40. Lower scores indicate less impairment.
Time frame: Baseline and Day 5
Population: Safety Set consisted of subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in Simpson Angus Scale (SAS) Total Score at Day 5: 200 mg | 0.0 units on a scale | Standard Error 0.52 |
| SPD489 (Lisdexamfetamine Dimesylate)(50 mg) | Change From Baseline in Simpson Angus Scale (SAS) Total Score at Day 5: 200 mg | 0.0 units on a scale | Standard Error 0.2 |
Secondary
Change From Baseline in Simpson Angus Scale (SAS) Total Score at Day 5: 250 mg
SAS is a 10-item scale used to evaluate the presence and severity of extrapyramidal symptoms. The items are scored on a scale from 0 to 4 with item-specific definitions given for each point. Total scores range from 0 to 40. Lower scores indicate less impairment.
Time frame: Baseline and Day 5
Population: Safety Set consisted of subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in Simpson Angus Scale (SAS) Total Score at Day 5: 250 mg | 0.2 units on a scale | Standard Error 0.31 |
| SPD489 (Lisdexamfetamine Dimesylate)(50 mg) | Change From Baseline in Simpson Angus Scale (SAS) Total Score at Day 5: 250 mg | 0.0 units on a scale | Standard Error 0.21 |
Secondary
Change From Baseline in Simpson Angus Scale (SAS) Total Score at Day 5: 50 mg
SAS is a 10-item scale used to evaluate the presence and severity of extrapyramidal symptoms. The items are scored on a scale from 0 to 4 with item-specific definitions given for each point. Total scores range from 0 to 40. Lower scores indicate less impairment.
Time frame: Baseline and Day 5
Population: Safety Set consisted of subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in Simpson Angus Scale (SAS) Total Score at Day 5: 50 mg | -0.4 units on a scale | Standard Error 0.3 |
| SPD489 (Lisdexamfetamine Dimesylate)(50 mg) | Change From Baseline in Simpson Angus Scale (SAS) Total Score at Day 5: 50 mg | 0.0 units on a scale | Standard Error 0.18 |
Secondary
Change From Baseline in Simpson Angus Scale (SAS) Total Score at Day 5: 70 mg
SAS is a 10-item scale used to evaluate the presence and severity of extrapyramidal symptoms. The items are scored on a scale from 0 to 4 with item-specific definitions given for each point. Total scores range from 0 to 40. Lower scores indicate less impairment.
Time frame: Baseline and Day 5
Population: Safety Set consisted of subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in Simpson Angus Scale (SAS) Total Score at Day 5: 70 mg | -0.6 units on a scale | Standard Error 0.43 |
| SPD489 (Lisdexamfetamine Dimesylate)(50 mg) | Change From Baseline in Simpson Angus Scale (SAS) Total Score at Day 5: 70 mg | -0.1 units on a scale | Standard Error 0.18 |
Secondary
Maximum Plasma Concentration (Cmax) of Lisdexamfetamine Dimesylate on Day 5: 100 mg
Cmax is a term that refers to the maximum (or peak) concentration that a drug achieves in the body after the drug has been administrated.
Time frame: Day 5 (12-hour sampling period post-dose)
Population: Pharmacokinetic Set defined as all subjects in the Safety set who had evaluable concentration-time profiles for lisdexamfetamine and/or d-amphetamine.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Maximum Plasma Concentration (Cmax) of Lisdexamfetamine Dimesylate on Day 5: 100 mg | 50.6 ng/ml | Standard Deviation 18.9 |
Secondary
Maximum Plasma Concentration (Cmax) of Lisdexamfetamine Dimesylate on Day 5: 150 mg
Cmax is a term that refers to the maximum (or peak) concentration that a drug achieves in the body after the drug has been administrated.
Time frame: Day 5 (12-hour sampling period post-dose)
Population: Pharmacokinetic Set defined as all subjects in the Safety set who had evaluable concentration-time profiles for lisdexamfetamine and/or d-amphetamine.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Maximum Plasma Concentration (Cmax) of Lisdexamfetamine Dimesylate on Day 5: 150 mg | 90.34 ng/ml | Standard Deviation 30.45 |
Secondary
Maximum Plasma Concentration (Cmax) of Lisdexamfetamine Dimesylate on Day 5: 200 mg
Cmax is a term that refers to the maximum (or peak) concentration that a drug achieves in the body after the drug has been administrated.
Time frame: Day 5 (12-hour sampling period post-dose)
Population: Pharmacokinetic Set defined as all subjects in the Safety set who had evaluable concentration-time profiles for lisdexamfetamine and/or d-amphetamine.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Maximum Plasma Concentration (Cmax) of Lisdexamfetamine Dimesylate on Day 5: 200 mg | 133.3 ng/ml | Standard Deviation 63.17 |
Secondary
Maximum Plasma Concentration (Cmax) of Lisdexamfetamine Dimesylate on Day 5: 250 mg
Cmax is a term that refers to the maximum (or peak) concentration that a drug achieves in the body after the drug has been administrated.
Time frame: Day 5 (12-hour sampling period post-dose)
Population: Pharmacokinetic Set defined as all subjects in the Safety set who had evaluable concentration-time profiles for lisdexamfetamine and/or d-amphetamine.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Maximum Plasma Concentration (Cmax) of Lisdexamfetamine Dimesylate on Day 5: 250 mg | 181.53 ng/ml | Standard Deviation 72.82 |
Secondary
Maximum Plasma Concentration (Cmax) of Lisdexamfetamine Dimesylate on Day 5: 50 mg
Cmax is a term that refers to the maximum (or peak) concentration that a drug achieves in the body after the drug has been administrated.
Time frame: Day 5 (12-hour sampling period post-dose)
Population: Pharmacokinetic Set defined as all subjects in the Safety set who had evaluable concentration-time profiles for lisdexamfetamine and/or d-amphetamine.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Maximum Plasma Concentration (Cmax) of Lisdexamfetamine Dimesylate on Day 5: 50 mg | 21.93 ng/ml | Standard Deviation 9.96 |
Secondary
Maximum Plasma Concentration (Cmax) of Lisdexamfetamine Dimesylate on Day 5: 70 mg
Cmax is a term that refers to the maximum (or peak) concentration that a drug achieves in the body after the drug has been administrated.
Time frame: Day 5 (12-hour sampling period post-dose)
Population: Pharmacokinetic Set defined as all subjects in the Safety set who had evaluable concentration-time profiles for lisdexamfetamine and/or d-amphetamine.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Maximum Plasma Concentration (Cmax) of Lisdexamfetamine Dimesylate on Day 5: 70 mg | 35.02 ng/ml | Standard Deviation 21.35 |