Trial Outcomes & Findings for Dose Response Effects of Quillivant XR in Children With ADHD and Autism: A Pilot Study (NCT NCT02255565)
NCT ID: NCT02255565
Last Updated: 2017-08-01
Results Overview
Measures the severity of Total ADHD symptoms, Inattention and Hyperactivity/Impulsive symptoms. The Inattention and Hyperactivity/Impulsive symptoms can range from 0 to 27 each, with a higher score reflecting more severe ADHD symptoms. The total score is calculated by summing the inattention and Hyperactivity/Impulsive subscales. The total score can range from 0 to 54 with a higher score reflecting more severe ADHD symptoms.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
36 participants
Primary outcome timeframe
once a week for 6 weeks
Results posted on
2017-08-01
Participant Flow
Eligible participants were recruited from the investigators' practices, clinic referrals, and letter mailings. Participants were enrolled between September 2014 and September 2016.
Of the 36 participants enrolled, 27 were randomized to receive treatment. 3 participants withdrew, 2 due to time commitment issues and 1 due to stress over screening. 6 participants were deemed ineligible for the study due to no Autism Spectrum Disorder (ASD) diagnosis based on screening assessments.
Participant milestones
| Measure |
Very Low Dose Quillivant XR
Patients in this treatment arm are given Quillivant XR (a liquid medication) to treat ADHD at a very low dose level for 6 weeks.
Very Low Dose Quillivant XR: Oral suspension dose once a day starting at 5mg and increasing to a 10mg dose
|
Low Dose Quillivant XR
Patients in this treatment arm are given Quillivant XR (a liquid medication) to treat ADHD at a low dose level for 6 weeks.
Low Dose Quillivant XR: Oral suspension dose once a day starting at 5mg and increasing to a 20mg dose
|
Moderate Dose Quillivant XR
Patients in this treatment arm are given Quillivant XR (a liquid medication) to treat ADHD at a moderate dose level for 6 weeks.
Moderate Dose Quillivant XR: Oral suspension dose once a day starting at 5mg and increasing to a 40mg dose
|
|---|---|---|---|
|
Overall Study
STARTED
|
9
|
9
|
9
|
|
Overall Study
COMPLETED
|
9
|
8
|
9
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
0
|
Reasons for withdrawal
| Measure |
Very Low Dose Quillivant XR
Patients in this treatment arm are given Quillivant XR (a liquid medication) to treat ADHD at a very low dose level for 6 weeks.
Very Low Dose Quillivant XR: Oral suspension dose once a day starting at 5mg and increasing to a 10mg dose
|
Low Dose Quillivant XR
Patients in this treatment arm are given Quillivant XR (a liquid medication) to treat ADHD at a low dose level for 6 weeks.
Low Dose Quillivant XR: Oral suspension dose once a day starting at 5mg and increasing to a 20mg dose
|
Moderate Dose Quillivant XR
Patients in this treatment arm are given Quillivant XR (a liquid medication) to treat ADHD at a moderate dose level for 6 weeks.
Moderate Dose Quillivant XR: Oral suspension dose once a day starting at 5mg and increasing to a 40mg dose
|
|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
0
|
Baseline Characteristics
Dose Response Effects of Quillivant XR in Children With ADHD and Autism: A Pilot Study
Baseline characteristics by cohort
| Measure |
Very Low Dose Quillivant XR
n=9 Participants
Patients in this treatment arm are given Quillivant XR (a liquid medication) to treat ADHD at a very low dose level for 6 weeks.
Very Low Dose Quillivant XR: Oral suspension dose once a day starting at 5mg and increasing to a 10mg dose
|
Low Dose Quillivant XR
n=9 Participants
Patients in this treatment arm are given Quillivant XR (a liquid medication) to treat ADHD at a low dose level for 6 weeks.
Low Dose Quillivant XR: Oral suspension dose once a day starting at 5mg and increasing to a 20mg dose
|
Moderate Dose Quillivant XR
n=9 Participants
Patients in this treatment arm are given Quillivant XR (a liquid medication) to treat ADHD at a moderate dose level for 6 weeks.
Moderate Dose Quillivant XR: Oral suspension dose once a day starting at 5mg and increasing to a 40mg dose
|
Total
n=27 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
9 Participants
n=99 Participants
|
9 Participants
n=107 Participants
|
9 Participants
n=206 Participants
|
27 Participants
n=7 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Age, Continuous
|
9.33 years
STANDARD_DEVIATION 2.92 • n=99 Participants
|
8.00 years
STANDARD_DEVIATION 2.96 • n=107 Participants
|
10.22 years
STANDARD_DEVIATION 3.03 • n=206 Participants
|
9.19 years
STANDARD_DEVIATION 3.00 • n=7 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
2 Participants
n=7 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=99 Participants
|
9 Participants
n=107 Participants
|
8 Participants
n=206 Participants
|
25 Participants
n=7 Participants
|
|
Region of Enrollment
United States
|
9 participants
n=99 Participants
|
9 participants
n=107 Participants
|
9 participants
n=206 Participants
|
26 participants
n=7 Participants
|
PRIMARY outcome
Timeframe: once a week for 6 weeksMeasures the severity of Total ADHD symptoms, Inattention and Hyperactivity/Impulsive symptoms. The Inattention and Hyperactivity/Impulsive symptoms can range from 0 to 27 each, with a higher score reflecting more severe ADHD symptoms. The total score is calculated by summing the inattention and Hyperactivity/Impulsive subscales. The total score can range from 0 to 54 with a higher score reflecting more severe ADHD symptoms.
Outcome measures
| Measure |
Very Low Dose Quillivant XR - Week 1
n=9 Participants
Patients in this treatment arm are given Quillivant XR (a liquid medication) to treat ADHD at a very low dose level for 6 weeks. The dose titration was based on the physician's discretion and parent-reported Adverse Events (AE's).
Very Low Dose Quillivant XR: Oral suspension dose once a day starting at 5mg and increasing to a 10mg dose
|
Very Low Dose Quillivant XR - Week 2
n=9 Participants
Patients in this treatment arm are given Quillivant XR (a liquid medication) to treat ADHD at a very low dose level for 6 weeks. The dose titration was based on the physician's discretion and parent-reported Adverse Events (AE's).
Very Low Dose Quillivant XR: Oral suspension dose once a day starting at 5mg and increasing to a 10mg dose
|
Very Low Dose Quillivant XR - Week 3
n=9 Participants
Patients in this treatment arm are given Quillivant XR (a liquid medication) to treat ADHD at a very low dose level for 6 weeks. The dose titration was based on the physician's discretion and parent-reported Adverse Events (AE's).
Very Low Dose Quillivant XR: Oral suspension dose once a day starting at 5mg and increasing to a 10mg dose
|
Very Low Dose Quillivant XR - Week 4
n=9 Participants
Patients in this treatment arm are given Quillivant XR (a liquid medication) to treat ADHD at a very low dose level for 6 weeks. The dose titration was based on the physician's discretion and parent-reported Adverse Events (AE's).
Very Low Dose Quillivant XR: Oral suspension dose once a day starting at 5mg and increasing to a 10mg dose
|
Very Low Dose Quillivant XR - Week 5
n=9 Participants
Patients in this treatment arm are given Quillivant XR (a liquid medication) to treat ADHD at a very low dose level for 6 weeks. The dose titration was based on the physician's discretion and parent-reported Adverse Events (AE's).
Very Low Dose Quillivant XR: Oral suspension dose once a day starting at 5mg and increasing to a 10mg dose
|
Very Low Dose Quillivant XR - Week 6
n=9 Participants
Patients in this treatment arm are given Quillivant XR (a liquid medication) to treat ADHD at a very low dose level for 6 weeks. The dose titration was based on the physician's discretion and parent-reported Adverse Events (AE's).
Very Low Dose Quillivant XR: Oral suspension dose once a day starting at 5mg and increasing to a 10mg dose
|
Low Dose Quillivant XR - Week 1
n=9 Participants
Patients in this treatment arm are given Quillivant XR (a liquid medication) to treat ADHD at a low dose level for 6 weeks.The dose titration was based on the physician's discretion and parent-reported Adverse Events (AE's).
Low Dose Quillivant XR: Oral suspension dose once a day starting at 5mg and increasing to a 20mg dose
|
Low Dose Quillivant XR - Week 2
n=9 Participants
Patients in this treatment arm are given Quillivant XR (a liquid medication) to treat ADHD at a low dose level for 6 weeks.The dose titration was based on the physician's discretion and parent-reported Adverse Events (AE's).
Low Dose Quillivant XR: Oral suspension dose once a day starting at 5mg and increasing to a 20mg dose
|
Low Dose Quillivant XR - Week 3
n=9 Participants
Patients in this treatment arm are given Quillivant XR (a liquid medication) to treat ADHD at a low dose level for 6 weeks.The dose titration was based on the physician's discretion and parent-reported Adverse Events (AE's).
Low Dose Quillivant XR: Oral suspension dose once a day starting at 5mg and increasing to a 20mg dose
|
Low Dose Quillivant XR - Week 4
n=8 Participants
Patients in this treatment arm are given Quillivant XR (a liquid medication) to treat ADHD at a low dose level for 6 weeks.The dose titration was based on the physician's discretion and parent-reported Adverse Events (AE's).
Low Dose Quillivant XR: Oral suspension dose once a day starting at 5mg and increasing to a 20mg dose
|
Low Dose Quillivant XR - Week 5
n=8 Participants
Patients in this treatment arm are given Quillivant XR (a liquid medication) to treat ADHD at a low dose level for 6 weeks.The dose titration was based on the physician's discretion and parent-reported Adverse Events (AE's).
Low Dose Quillivant XR: Oral suspension dose once a day starting at 5mg and increasing to a 20mg dose
|
Low Dose Quillivant XR - Week 6
n=9 Participants
Patients in this treatment arm are given Quillivant XR (a liquid medication) to treat ADHD at a low dose level for 6 weeks.The dose titration was based on the physician's discretion and parent-reported Adverse Events (AE's).
Low Dose Quillivant XR: Oral suspension dose once a day starting at 5mg and increasing to a 20mg dose
|
Moderate Dose Quillivant XR - Week 1
n=9 Participants
Patients in this treatment arm are given Quillivant XR (a liquid medication) to treat ADHD at a moderate dose level for 6 weeks. The dose titration was based on the physician's discretion and parent-reported Adverse Events (AE's).
Moderate Dose Quillivant XR: Oral suspension dose once a day starting at 5mg and increasing to a 40mg dose
|
Moderate Dose Quillivant XR - Week 2
n=9 Participants
Patients in this treatment arm are given Quillivant XR (a liquid medication) to treat ADHD at a moderate dose level for 6 weeks. The dose titration was based on the physician's discretion and parent-reported Adverse Events (AE's).
Moderate Dose Quillivant XR: Oral suspension dose once a day starting at 5mg and increasing to a 40mg dose
|
Moderate Dose Quillivant XR - Week 3
n=9 Participants
Patients in this treatment arm are given Quillivant XR (a liquid medication) to treat ADHD at a moderate dose level for 6 weeks. The dose titration was based on the physician's discretion and parent-reported Adverse Events (AE's).
Moderate Dose Quillivant XR: Oral suspension dose once a day starting at 5mg and increasing to a 40mg dose
|
Moderate Dose Quillivant XR - Week 4
n=9 Participants
Patients in this treatment arm are given Quillivant XR (a liquid medication) to treat ADHD at a moderate dose level for 6 weeks. The dose titration was based on the physician's discretion and parent-reported Adverse Events (AE's).
Moderate Dose Quillivant XR: Oral suspension dose once a day starting at 5mg and increasing to a 40mg dose
|
Moderate Dose Quillivant XR - Week 5
n=9 Participants
Patients in this treatment arm are given Quillivant XR (a liquid medication) to treat ADHD at a moderate dose level for 6 weeks. The dose titration was based on the physician's discretion and parent-reported Adverse Events (AE's).
Moderate Dose Quillivant XR: Oral suspension dose once a day starting at 5mg and increasing to a 40mg dose
|
Moderate Dose Quillivant XR - Week 6
n=9 Participants
Patients in this treatment arm are given Quillivant XR (a liquid medication) to treat ADHD at a moderate dose level for 6 weeks. The dose titration was based on the physician's discretion and parent-reported Adverse Events (AE's).
Moderate Dose Quillivant XR: Oral suspension dose once a day starting at 5mg and increasing to a 40mg dose
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
ADHD Rating Scale - IV
Inattention Subscale Score
|
17.89 units on a scale
Standard Deviation 3.95
|
16.78 units on a scale
Standard Deviation 4.18
|
16.67 units on a scale
Standard Deviation 2.74
|
14.33 units on a scale
Standard Deviation 6.26
|
14.56 units on a scale
Standard Deviation 5.53
|
12.89 units on a scale
Standard Deviation 5.01
|
16.33 units on a scale
Standard Deviation 6.89
|
14.00 units on a scale
Standard Deviation 5.83
|
12.00 units on a scale
Standard Deviation 5.22
|
8.38 units on a scale
Standard Deviation 5.90
|
9.50 units on a scale
Standard Deviation 4.57
|
9.56 units on a scale
Standard Deviation 6.17
|
18.11 units on a scale
Standard Deviation 4.43
|
14.67 units on a scale
Standard Deviation 5.15
|
13.67 units on a scale
Standard Deviation 6.98
|
13.56 units on a scale
Standard Deviation 5.10
|
13.00 units on a scale
Standard Deviation 5.55
|
11.78 units on a scale
Standard Deviation 5.43
|
|
ADHD Rating Scale - IV
Hyperactivity Subscale Score
|
12.44 units on a scale
Standard Deviation 7.91
|
10.56 units on a scale
Standard Deviation 8.16
|
11.56 units on a scale
Standard Deviation 6.25
|
12.33 units on a scale
Standard Deviation 5.70
|
9.22 units on a scale
Standard Deviation 7.55
|
8.78 units on a scale
Standard Deviation 5.67
|
15.33 units on a scale
Standard Deviation 8.23
|
14.33 units on a scale
Standard Deviation 7.38
|
10.22 units on a scale
Standard Deviation 5.24
|
6.88 units on a scale
Standard Deviation 4.42
|
9.38 units on a scale
Standard Deviation 4.75
|
6.56 units on a scale
Standard Deviation 4.28
|
12.78 units on a scale
Standard Deviation 3.87
|
11.33 units on a scale
Standard Deviation 2.78
|
11.78 units on a scale
Standard Deviation 6.26
|
9.67 units on a scale
Standard Deviation 5.87
|
9.22 units on a scale
Standard Deviation 5.83
|
7.33 units on a scale
Standard Deviation 2.87
|
|
ADHD Rating Scale - IV
Total Score
|
30.33 units on a scale
Standard Deviation 9.27
|
27.33 units on a scale
Standard Deviation 11.14
|
28.22 units on a scale
Standard Deviation 7.24
|
26.67 units on a scale
Standard Deviation 10.20
|
23.78 units on a scale
Standard Deviation 11.51
|
21.67 units on a scale
Standard Deviation 7.78
|
31.67 units on a scale
Standard Deviation 14.67
|
28.33 units on a scale
Standard Deviation 12.41
|
22.22 units on a scale
Standard Deviation 9.90
|
15.25 units on a scale
Standard Deviation 9.77
|
18.88 units on a scale
Standard Deviation 9.06
|
16.11 units on a scale
Standard Deviation 8.99
|
30.89 units on a scale
Standard Deviation 6.17
|
26.00 units on a scale
Standard Deviation 5.87
|
25.44 units on a scale
Standard Deviation 12.70
|
23.22 units on a scale
Standard Deviation 10.02
|
22.22 units on a scale
Standard Deviation 10.03
|
19.11 units on a scale
Standard Deviation 7.44
|
SECONDARY outcome
Timeframe: once a week for 6 weeksThe CGI-S scale summarizes the clinician's impression of the participant's symptom severity and ranges from 1-7 with 1 representing normal (not at all ill) and 7 representing extremely ill.
Outcome measures
| Measure |
Very Low Dose Quillivant XR - Week 1
n=9 Participants
Patients in this treatment arm are given Quillivant XR (a liquid medication) to treat ADHD at a very low dose level for 6 weeks. The dose titration was based on the physician's discretion and parent-reported Adverse Events (AE's).
Very Low Dose Quillivant XR: Oral suspension dose once a day starting at 5mg and increasing to a 10mg dose
|
Very Low Dose Quillivant XR - Week 2
n=9 Participants
Patients in this treatment arm are given Quillivant XR (a liquid medication) to treat ADHD at a very low dose level for 6 weeks. The dose titration was based on the physician's discretion and parent-reported Adverse Events (AE's).
Very Low Dose Quillivant XR: Oral suspension dose once a day starting at 5mg and increasing to a 10mg dose
|
Very Low Dose Quillivant XR - Week 3
n=9 Participants
Patients in this treatment arm are given Quillivant XR (a liquid medication) to treat ADHD at a very low dose level for 6 weeks. The dose titration was based on the physician's discretion and parent-reported Adverse Events (AE's).
Very Low Dose Quillivant XR: Oral suspension dose once a day starting at 5mg and increasing to a 10mg dose
|
Very Low Dose Quillivant XR - Week 4
n=9 Participants
Patients in this treatment arm are given Quillivant XR (a liquid medication) to treat ADHD at a very low dose level for 6 weeks. The dose titration was based on the physician's discretion and parent-reported Adverse Events (AE's).
Very Low Dose Quillivant XR: Oral suspension dose once a day starting at 5mg and increasing to a 10mg dose
|
Very Low Dose Quillivant XR - Week 5
n=9 Participants
Patients in this treatment arm are given Quillivant XR (a liquid medication) to treat ADHD at a very low dose level for 6 weeks. The dose titration was based on the physician's discretion and parent-reported Adverse Events (AE's).
Very Low Dose Quillivant XR: Oral suspension dose once a day starting at 5mg and increasing to a 10mg dose
|
Very Low Dose Quillivant XR - Week 6
n=9 Participants
Patients in this treatment arm are given Quillivant XR (a liquid medication) to treat ADHD at a very low dose level for 6 weeks. The dose titration was based on the physician's discretion and parent-reported Adverse Events (AE's).
Very Low Dose Quillivant XR: Oral suspension dose once a day starting at 5mg and increasing to a 10mg dose
|
Low Dose Quillivant XR - Week 1
n=9 Participants
Patients in this treatment arm are given Quillivant XR (a liquid medication) to treat ADHD at a low dose level for 6 weeks.The dose titration was based on the physician's discretion and parent-reported Adverse Events (AE's).
Low Dose Quillivant XR: Oral suspension dose once a day starting at 5mg and increasing to a 20mg dose
|
Low Dose Quillivant XR - Week 2
n=9 Participants
Patients in this treatment arm are given Quillivant XR (a liquid medication) to treat ADHD at a low dose level for 6 weeks.The dose titration was based on the physician's discretion and parent-reported Adverse Events (AE's).
Low Dose Quillivant XR: Oral suspension dose once a day starting at 5mg and increasing to a 20mg dose
|
Low Dose Quillivant XR - Week 3
n=9 Participants
Patients in this treatment arm are given Quillivant XR (a liquid medication) to treat ADHD at a low dose level for 6 weeks.The dose titration was based on the physician's discretion and parent-reported Adverse Events (AE's).
Low Dose Quillivant XR: Oral suspension dose once a day starting at 5mg and increasing to a 20mg dose
|
Low Dose Quillivant XR - Week 4
n=8 Participants
Patients in this treatment arm are given Quillivant XR (a liquid medication) to treat ADHD at a low dose level for 6 weeks.The dose titration was based on the physician's discretion and parent-reported Adverse Events (AE's).
Low Dose Quillivant XR: Oral suspension dose once a day starting at 5mg and increasing to a 20mg dose
|
Low Dose Quillivant XR - Week 5
n=8 Participants
Patients in this treatment arm are given Quillivant XR (a liquid medication) to treat ADHD at a low dose level for 6 weeks.The dose titration was based on the physician's discretion and parent-reported Adverse Events (AE's).
Low Dose Quillivant XR: Oral suspension dose once a day starting at 5mg and increasing to a 20mg dose
|
Low Dose Quillivant XR - Week 6
n=9 Participants
Patients in this treatment arm are given Quillivant XR (a liquid medication) to treat ADHD at a low dose level for 6 weeks.The dose titration was based on the physician's discretion and parent-reported Adverse Events (AE's).
Low Dose Quillivant XR: Oral suspension dose once a day starting at 5mg and increasing to a 20mg dose
|
Moderate Dose Quillivant XR - Week 1
n=9 Participants
Patients in this treatment arm are given Quillivant XR (a liquid medication) to treat ADHD at a moderate dose level for 6 weeks. The dose titration was based on the physician's discretion and parent-reported Adverse Events (AE's).
Moderate Dose Quillivant XR: Oral suspension dose once a day starting at 5mg and increasing to a 40mg dose
|
Moderate Dose Quillivant XR - Week 2
n=9 Participants
Patients in this treatment arm are given Quillivant XR (a liquid medication) to treat ADHD at a moderate dose level for 6 weeks. The dose titration was based on the physician's discretion and parent-reported Adverse Events (AE's).
Moderate Dose Quillivant XR: Oral suspension dose once a day starting at 5mg and increasing to a 40mg dose
|
Moderate Dose Quillivant XR - Week 3
n=9 Participants
Patients in this treatment arm are given Quillivant XR (a liquid medication) to treat ADHD at a moderate dose level for 6 weeks. The dose titration was based on the physician's discretion and parent-reported Adverse Events (AE's).
Moderate Dose Quillivant XR: Oral suspension dose once a day starting at 5mg and increasing to a 40mg dose
|
Moderate Dose Quillivant XR - Week 4
n=9 Participants
Patients in this treatment arm are given Quillivant XR (a liquid medication) to treat ADHD at a moderate dose level for 6 weeks. The dose titration was based on the physician's discretion and parent-reported Adverse Events (AE's).
Moderate Dose Quillivant XR: Oral suspension dose once a day starting at 5mg and increasing to a 40mg dose
|
Moderate Dose Quillivant XR - Week 5
n=9 Participants
Patients in this treatment arm are given Quillivant XR (a liquid medication) to treat ADHD at a moderate dose level for 6 weeks. The dose titration was based on the physician's discretion and parent-reported Adverse Events (AE's).
Moderate Dose Quillivant XR: Oral suspension dose once a day starting at 5mg and increasing to a 40mg dose
|
Moderate Dose Quillivant XR - Week 6
n=9 Participants
Patients in this treatment arm are given Quillivant XR (a liquid medication) to treat ADHD at a moderate dose level for 6 weeks. The dose titration was based on the physician's discretion and parent-reported Adverse Events (AE's).
Moderate Dose Quillivant XR: Oral suspension dose once a day starting at 5mg and increasing to a 40mg dose
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Clinical Global Impressions-ADHD - Severity
|
4.78 units on a scale
Standard Deviation 0.44
|
4.33 units on a scale
Standard Deviation 0.87
|
4.44 units on a scale
Standard Deviation 0.88
|
4.33 units on a scale
Standard Deviation 0.87
|
4.11 units on a scale
Standard Deviation 1.05
|
4.00 units on a scale
Standard Deviation 0.87
|
4.33 units on a scale
Standard Deviation 1.12
|
4.00 units on a scale
Standard Deviation 1.22
|
3.67 units on a scale
Standard Deviation 1.00
|
2.75 units on a scale
Standard Deviation 1.16
|
2.88 units on a scale
Standard Deviation 1.25
|
2.78 units on a scale
Standard Deviation 1.30
|
4.89 units on a scale
Standard Deviation 0.33
|
4.56 units on a scale
Standard Deviation 0.53
|
4.11 units on a scale
Standard Deviation 0.60
|
4.00 units on a scale
Standard Deviation 0.71
|
3.56 units on a scale
Standard Deviation 0.88
|
3.44 units on a scale
Standard Deviation 1.24
|
SECONDARY outcome
Timeframe: once a week for 6 weeksThe CGI-I scale summarizes the clinician's impression of the participant's symptom improvement and ranges from 1-7 with 1 representing very much improved and 7 representing very much worse.
Outcome measures
| Measure |
Very Low Dose Quillivant XR - Week 1
n=9 Participants
Patients in this treatment arm are given Quillivant XR (a liquid medication) to treat ADHD at a very low dose level for 6 weeks. The dose titration was based on the physician's discretion and parent-reported Adverse Events (AE's).
Very Low Dose Quillivant XR: Oral suspension dose once a day starting at 5mg and increasing to a 10mg dose
|
Very Low Dose Quillivant XR - Week 2
n=9 Participants
Patients in this treatment arm are given Quillivant XR (a liquid medication) to treat ADHD at a very low dose level for 6 weeks. The dose titration was based on the physician's discretion and parent-reported Adverse Events (AE's).
Very Low Dose Quillivant XR: Oral suspension dose once a day starting at 5mg and increasing to a 10mg dose
|
Very Low Dose Quillivant XR - Week 3
n=9 Participants
Patients in this treatment arm are given Quillivant XR (a liquid medication) to treat ADHD at a very low dose level for 6 weeks. The dose titration was based on the physician's discretion and parent-reported Adverse Events (AE's).
Very Low Dose Quillivant XR: Oral suspension dose once a day starting at 5mg and increasing to a 10mg dose
|
Very Low Dose Quillivant XR - Week 4
n=9 Participants
Patients in this treatment arm are given Quillivant XR (a liquid medication) to treat ADHD at a very low dose level for 6 weeks. The dose titration was based on the physician's discretion and parent-reported Adverse Events (AE's).
Very Low Dose Quillivant XR: Oral suspension dose once a day starting at 5mg and increasing to a 10mg dose
|
Very Low Dose Quillivant XR - Week 5
n=9 Participants
Patients in this treatment arm are given Quillivant XR (a liquid medication) to treat ADHD at a very low dose level for 6 weeks. The dose titration was based on the physician's discretion and parent-reported Adverse Events (AE's).
Very Low Dose Quillivant XR: Oral suspension dose once a day starting at 5mg and increasing to a 10mg dose
|
Very Low Dose Quillivant XR - Week 6
n=9 Participants
Patients in this treatment arm are given Quillivant XR (a liquid medication) to treat ADHD at a very low dose level for 6 weeks. The dose titration was based on the physician's discretion and parent-reported Adverse Events (AE's).
Very Low Dose Quillivant XR: Oral suspension dose once a day starting at 5mg and increasing to a 10mg dose
|
Low Dose Quillivant XR - Week 1
n=9 Participants
Patients in this treatment arm are given Quillivant XR (a liquid medication) to treat ADHD at a low dose level for 6 weeks.The dose titration was based on the physician's discretion and parent-reported Adverse Events (AE's).
Low Dose Quillivant XR: Oral suspension dose once a day starting at 5mg and increasing to a 20mg dose
|
Low Dose Quillivant XR - Week 2
n=9 Participants
Patients in this treatment arm are given Quillivant XR (a liquid medication) to treat ADHD at a low dose level for 6 weeks.The dose titration was based on the physician's discretion and parent-reported Adverse Events (AE's).
Low Dose Quillivant XR: Oral suspension dose once a day starting at 5mg and increasing to a 20mg dose
|
Low Dose Quillivant XR - Week 3
n=9 Participants
Patients in this treatment arm are given Quillivant XR (a liquid medication) to treat ADHD at a low dose level for 6 weeks.The dose titration was based on the physician's discretion and parent-reported Adverse Events (AE's).
Low Dose Quillivant XR: Oral suspension dose once a day starting at 5mg and increasing to a 20mg dose
|
Low Dose Quillivant XR - Week 4
n=8 Participants
Patients in this treatment arm are given Quillivant XR (a liquid medication) to treat ADHD at a low dose level for 6 weeks.The dose titration was based on the physician's discretion and parent-reported Adverse Events (AE's).
Low Dose Quillivant XR: Oral suspension dose once a day starting at 5mg and increasing to a 20mg dose
|
Low Dose Quillivant XR - Week 5
n=8 Participants
Patients in this treatment arm are given Quillivant XR (a liquid medication) to treat ADHD at a low dose level for 6 weeks.The dose titration was based on the physician's discretion and parent-reported Adverse Events (AE's).
Low Dose Quillivant XR: Oral suspension dose once a day starting at 5mg and increasing to a 20mg dose
|
Low Dose Quillivant XR - Week 6
n=9 Participants
Patients in this treatment arm are given Quillivant XR (a liquid medication) to treat ADHD at a low dose level for 6 weeks.The dose titration was based on the physician's discretion and parent-reported Adverse Events (AE's).
Low Dose Quillivant XR: Oral suspension dose once a day starting at 5mg and increasing to a 20mg dose
|
Moderate Dose Quillivant XR - Week 1
n=9 Participants
Patients in this treatment arm are given Quillivant XR (a liquid medication) to treat ADHD at a moderate dose level for 6 weeks. The dose titration was based on the physician's discretion and parent-reported Adverse Events (AE's).
Moderate Dose Quillivant XR: Oral suspension dose once a day starting at 5mg and increasing to a 40mg dose
|
Moderate Dose Quillivant XR - Week 2
n=9 Participants
Patients in this treatment arm are given Quillivant XR (a liquid medication) to treat ADHD at a moderate dose level for 6 weeks. The dose titration was based on the physician's discretion and parent-reported Adverse Events (AE's).
Moderate Dose Quillivant XR: Oral suspension dose once a day starting at 5mg and increasing to a 40mg dose
|
Moderate Dose Quillivant XR - Week 3
n=9 Participants
Patients in this treatment arm are given Quillivant XR (a liquid medication) to treat ADHD at a moderate dose level for 6 weeks. The dose titration was based on the physician's discretion and parent-reported Adverse Events (AE's).
Moderate Dose Quillivant XR: Oral suspension dose once a day starting at 5mg and increasing to a 40mg dose
|
Moderate Dose Quillivant XR - Week 4
n=9 Participants
Patients in this treatment arm are given Quillivant XR (a liquid medication) to treat ADHD at a moderate dose level for 6 weeks. The dose titration was based on the physician's discretion and parent-reported Adverse Events (AE's).
Moderate Dose Quillivant XR: Oral suspension dose once a day starting at 5mg and increasing to a 40mg dose
|
Moderate Dose Quillivant XR - Week 5
n=9 Participants
Patients in this treatment arm are given Quillivant XR (a liquid medication) to treat ADHD at a moderate dose level for 6 weeks. The dose titration was based on the physician's discretion and parent-reported Adverse Events (AE's).
Moderate Dose Quillivant XR: Oral suspension dose once a day starting at 5mg and increasing to a 40mg dose
|
Moderate Dose Quillivant XR - Week 6
n=9 Participants
Patients in this treatment arm are given Quillivant XR (a liquid medication) to treat ADHD at a moderate dose level for 6 weeks. The dose titration was based on the physician's discretion and parent-reported Adverse Events (AE's).
Moderate Dose Quillivant XR: Oral suspension dose once a day starting at 5mg and increasing to a 40mg dose
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Clinical Global Impression - Improvement (CGI-I)
|
3.89 units on a scale
Standard Deviation 0.60
|
3.56 units on a scale
Standard Deviation 0.88
|
3.44 units on a scale
Standard Deviation 0.53
|
3.22 units on a scale
Standard Deviation 0.83
|
3.00 units on a scale
Standard Deviation 1.00
|
2.89 units on a scale
Standard Deviation 0.78
|
3.78 units on a scale
Standard Deviation 1.30
|
3.00 units on a scale
Standard Deviation 0.87
|
2.22 units on a scale
Standard Deviation 0.83
|
1.63 units on a scale
Standard Deviation 0.74
|
2.13 units on a scale
Standard Deviation 0.99
|
2.00 units on a scale
Standard Deviation 0.87
|
3.33 units on a scale
Standard Deviation 0.50
|
3.11 units on a scale
Standard Deviation 0.60
|
2.67 units on a scale
Standard Deviation 1.12
|
2.89 units on a scale
Standard Deviation 0.60
|
2.56 units on a scale
Standard Deviation 1.01
|
2.22 units on a scale
Standard Deviation 0.83
|
Adverse Events
Very Low Dose Quillivant XR
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
Low Dose Quillivant XR
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
Moderate Dose Quillivant XR
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Very Low Dose Quillivant XR
n=9 participants at risk
Patients in this treatment arm are given Quillivant XR (a liquid medication) to treat ADHD at a very low dose level for 6 weeks.
Very Low Dose Quillivant XR: Oral suspension dose once a day starting at 5mg and increasing to a 10mg dose
|
Low Dose Quillivant XR
n=9 participants at risk
Patients in this treatment arm are given Quillivant XR (a liquid medication) to treat ADHD at a low dose level for 6 weeks.
Low Dose Quillivant XR: Oral suspension dose once a day starting at 5mg and increasing to a 20mg dose
|
Moderate Dose Quillivant XR
n=9 participants at risk
Patients in this treatment arm are given Quillivant XR (a liquid medication) to treat ADHD at a moderate dose level for 6 weeks.
Moderate Dose Quillivant XR: Oral suspension dose once a day starting at 5mg and increasing to a 40mg dose
|
|---|---|---|---|
|
General disorders
Difficulty Falling Asleep
|
55.6%
5/9 • Number of events 17 • 6 weeks. Adverse events were collected from participants while they were in the study, this time frame was 6 weeks.
At each weekly visit, children and their parents met with the investigators and research staff. Parents completed the Response Impressions Side Effects Checklist - Kids (RISK Checklist), a 38-item scale that is rated on a 10-point (0-9) scale ranging from absent to serious.
|
66.7%
6/9 • Number of events 10 • 6 weeks. Adverse events were collected from participants while they were in the study, this time frame was 6 weeks.
At each weekly visit, children and their parents met with the investigators and research staff. Parents completed the Response Impressions Side Effects Checklist - Kids (RISK Checklist), a 38-item scale that is rated on a 10-point (0-9) scale ranging from absent to serious.
|
66.7%
6/9 • Number of events 17 • 6 weeks. Adverse events were collected from participants while they were in the study, this time frame was 6 weeks.
At each weekly visit, children and their parents met with the investigators and research staff. Parents completed the Response Impressions Side Effects Checklist - Kids (RISK Checklist), a 38-item scale that is rated on a 10-point (0-9) scale ranging from absent to serious.
|
|
General disorders
Waking at Night
|
22.2%
2/9 • Number of events 2 • 6 weeks. Adverse events were collected from participants while they were in the study, this time frame was 6 weeks.
At each weekly visit, children and their parents met with the investigators and research staff. Parents completed the Response Impressions Side Effects Checklist - Kids (RISK Checklist), a 38-item scale that is rated on a 10-point (0-9) scale ranging from absent to serious.
|
22.2%
2/9 • Number of events 5 • 6 weeks. Adverse events were collected from participants while they were in the study, this time frame was 6 weeks.
At each weekly visit, children and their parents met with the investigators and research staff. Parents completed the Response Impressions Side Effects Checklist - Kids (RISK Checklist), a 38-item scale that is rated on a 10-point (0-9) scale ranging from absent to serious.
|
11.1%
1/9 • Number of events 1 • 6 weeks. Adverse events were collected from participants while they were in the study, this time frame was 6 weeks.
At each weekly visit, children and their parents met with the investigators and research staff. Parents completed the Response Impressions Side Effects Checklist - Kids (RISK Checklist), a 38-item scale that is rated on a 10-point (0-9) scale ranging from absent to serious.
|
|
General disorders
Waking up Early
|
33.3%
3/9 • Number of events 9 • 6 weeks. Adverse events were collected from participants while they were in the study, this time frame was 6 weeks.
At each weekly visit, children and their parents met with the investigators and research staff. Parents completed the Response Impressions Side Effects Checklist - Kids (RISK Checklist), a 38-item scale that is rated on a 10-point (0-9) scale ranging from absent to serious.
|
55.6%
5/9 • Number of events 16 • 6 weeks. Adverse events were collected from participants while they were in the study, this time frame was 6 weeks.
At each weekly visit, children and their parents met with the investigators and research staff. Parents completed the Response Impressions Side Effects Checklist - Kids (RISK Checklist), a 38-item scale that is rated on a 10-point (0-9) scale ranging from absent to serious.
|
22.2%
2/9 • Number of events 5 • 6 weeks. Adverse events were collected from participants while they were in the study, this time frame was 6 weeks.
At each weekly visit, children and their parents met with the investigators and research staff. Parents completed the Response Impressions Side Effects Checklist - Kids (RISK Checklist), a 38-item scale that is rated on a 10-point (0-9) scale ranging from absent to serious.
|
|
General disorders
Nightmares
|
11.1%
1/9 • Number of events 1 • 6 weeks. Adverse events were collected from participants while they were in the study, this time frame was 6 weeks.
At each weekly visit, children and their parents met with the investigators and research staff. Parents completed the Response Impressions Side Effects Checklist - Kids (RISK Checklist), a 38-item scale that is rated on a 10-point (0-9) scale ranging from absent to serious.
|
0.00%
0/9 • 6 weeks. Adverse events were collected from participants while they were in the study, this time frame was 6 weeks.
At each weekly visit, children and their parents met with the investigators and research staff. Parents completed the Response Impressions Side Effects Checklist - Kids (RISK Checklist), a 38-item scale that is rated on a 10-point (0-9) scale ranging from absent to serious.
|
11.1%
1/9 • Number of events 1 • 6 weeks. Adverse events were collected from participants while they were in the study, this time frame was 6 weeks.
At each weekly visit, children and their parents met with the investigators and research staff. Parents completed the Response Impressions Side Effects Checklist - Kids (RISK Checklist), a 38-item scale that is rated on a 10-point (0-9) scale ranging from absent to serious.
|
|
Psychiatric disorders
Flat Affect / No Emotion
|
22.2%
2/9 • Number of events 3 • 6 weeks. Adverse events were collected from participants while they were in the study, this time frame was 6 weeks.
At each weekly visit, children and their parents met with the investigators and research staff. Parents completed the Response Impressions Side Effects Checklist - Kids (RISK Checklist), a 38-item scale that is rated on a 10-point (0-9) scale ranging from absent to serious.
|
0.00%
0/9 • 6 weeks. Adverse events were collected from participants while they were in the study, this time frame was 6 weeks.
At each weekly visit, children and their parents met with the investigators and research staff. Parents completed the Response Impressions Side Effects Checklist - Kids (RISK Checklist), a 38-item scale that is rated on a 10-point (0-9) scale ranging from absent to serious.
|
22.2%
2/9 • Number of events 2 • 6 weeks. Adverse events were collected from participants while they were in the study, this time frame was 6 weeks.
At each weekly visit, children and their parents met with the investigators and research staff. Parents completed the Response Impressions Side Effects Checklist - Kids (RISK Checklist), a 38-item scale that is rated on a 10-point (0-9) scale ranging from absent to serious.
|
|
Psychiatric disorders
Rebound at end of day
|
44.4%
4/9 • Number of events 16 • 6 weeks. Adverse events were collected from participants while they were in the study, this time frame was 6 weeks.
At each weekly visit, children and their parents met with the investigators and research staff. Parents completed the Response Impressions Side Effects Checklist - Kids (RISK Checklist), a 38-item scale that is rated on a 10-point (0-9) scale ranging from absent to serious.
|
44.4%
4/9 • Number of events 19 • 6 weeks. Adverse events were collected from participants while they were in the study, this time frame was 6 weeks.
At each weekly visit, children and their parents met with the investigators and research staff. Parents completed the Response Impressions Side Effects Checklist - Kids (RISK Checklist), a 38-item scale that is rated on a 10-point (0-9) scale ranging from absent to serious.
|
55.6%
5/9 • Number of events 15 • 6 weeks. Adverse events were collected from participants while they were in the study, this time frame was 6 weeks.
At each weekly visit, children and their parents met with the investigators and research staff. Parents completed the Response Impressions Side Effects Checklist - Kids (RISK Checklist), a 38-item scale that is rated on a 10-point (0-9) scale ranging from absent to serious.
|
|
Psychiatric disorders
Aggression
|
66.7%
6/9 • Number of events 16 • 6 weeks. Adverse events were collected from participants while they were in the study, this time frame was 6 weeks.
At each weekly visit, children and their parents met with the investigators and research staff. Parents completed the Response Impressions Side Effects Checklist - Kids (RISK Checklist), a 38-item scale that is rated on a 10-point (0-9) scale ranging from absent to serious.
|
22.2%
2/9 • Number of events 5 • 6 weeks. Adverse events were collected from participants while they were in the study, this time frame was 6 weeks.
At each weekly visit, children and their parents met with the investigators and research staff. Parents completed the Response Impressions Side Effects Checklist - Kids (RISK Checklist), a 38-item scale that is rated on a 10-point (0-9) scale ranging from absent to serious.
|
44.4%
4/9 • Number of events 7 • 6 weeks. Adverse events were collected from participants while they were in the study, this time frame was 6 weeks.
At each weekly visit, children and their parents met with the investigators and research staff. Parents completed the Response Impressions Side Effects Checklist - Kids (RISK Checklist), a 38-item scale that is rated on a 10-point (0-9) scale ranging from absent to serious.
|
|
General disorders
Talks less
|
22.2%
2/9 • Number of events 3 • 6 weeks. Adverse events were collected from participants while they were in the study, this time frame was 6 weeks.
At each weekly visit, children and their parents met with the investigators and research staff. Parents completed the Response Impressions Side Effects Checklist - Kids (RISK Checklist), a 38-item scale that is rated on a 10-point (0-9) scale ranging from absent to serious.
|
11.1%
1/9 • Number of events 1 • 6 weeks. Adverse events were collected from participants while they were in the study, this time frame was 6 weeks.
At each weekly visit, children and their parents met with the investigators and research staff. Parents completed the Response Impressions Side Effects Checklist - Kids (RISK Checklist), a 38-item scale that is rated on a 10-point (0-9) scale ranging from absent to serious.
|
22.2%
2/9 • Number of events 2 • 6 weeks. Adverse events were collected from participants while they were in the study, this time frame was 6 weeks.
At each weekly visit, children and their parents met with the investigators and research staff. Parents completed the Response Impressions Side Effects Checklist - Kids (RISK Checklist), a 38-item scale that is rated on a 10-point (0-9) scale ranging from absent to serious.
|
|
General disorders
Uninterested
|
22.2%
2/9 • Number of events 7 • 6 weeks. Adverse events were collected from participants while they were in the study, this time frame was 6 weeks.
At each weekly visit, children and their parents met with the investigators and research staff. Parents completed the Response Impressions Side Effects Checklist - Kids (RISK Checklist), a 38-item scale that is rated on a 10-point (0-9) scale ranging from absent to serious.
|
11.1%
1/9 • Number of events 1 • 6 weeks. Adverse events were collected from participants while they were in the study, this time frame was 6 weeks.
At each weekly visit, children and their parents met with the investigators and research staff. Parents completed the Response Impressions Side Effects Checklist - Kids (RISK Checklist), a 38-item scale that is rated on a 10-point (0-9) scale ranging from absent to serious.
|
44.4%
4/9 • Number of events 5 • 6 weeks. Adverse events were collected from participants while they were in the study, this time frame was 6 weeks.
At each weekly visit, children and their parents met with the investigators and research staff. Parents completed the Response Impressions Side Effects Checklist - Kids (RISK Checklist), a 38-item scale that is rated on a 10-point (0-9) scale ranging from absent to serious.
|
|
General disorders
Decreased Appetite
|
33.3%
3/9 • Number of events 9 • 6 weeks. Adverse events were collected from participants while they were in the study, this time frame was 6 weeks.
At each weekly visit, children and their parents met with the investigators and research staff. Parents completed the Response Impressions Side Effects Checklist - Kids (RISK Checklist), a 38-item scale that is rated on a 10-point (0-9) scale ranging from absent to serious.
|
66.7%
6/9 • Number of events 13 • 6 weeks. Adverse events were collected from participants while they were in the study, this time frame was 6 weeks.
At each weekly visit, children and their parents met with the investigators and research staff. Parents completed the Response Impressions Side Effects Checklist - Kids (RISK Checklist), a 38-item scale that is rated on a 10-point (0-9) scale ranging from absent to serious.
|
44.4%
4/9 • Number of events 13 • 6 weeks. Adverse events were collected from participants while they were in the study, this time frame was 6 weeks.
At each weekly visit, children and their parents met with the investigators and research staff. Parents completed the Response Impressions Side Effects Checklist - Kids (RISK Checklist), a 38-item scale that is rated on a 10-point (0-9) scale ranging from absent to serious.
|
|
General disorders
Irritable
|
77.8%
7/9 • Number of events 22 • 6 weeks. Adverse events were collected from participants while they were in the study, this time frame was 6 weeks.
At each weekly visit, children and their parents met with the investigators and research staff. Parents completed the Response Impressions Side Effects Checklist - Kids (RISK Checklist), a 38-item scale that is rated on a 10-point (0-9) scale ranging from absent to serious.
|
44.4%
4/9 • Number of events 6 • 6 weeks. Adverse events were collected from participants while they were in the study, this time frame was 6 weeks.
At each weekly visit, children and their parents met with the investigators and research staff. Parents completed the Response Impressions Side Effects Checklist - Kids (RISK Checklist), a 38-item scale that is rated on a 10-point (0-9) scale ranging from absent to serious.
|
44.4%
4/9 • Number of events 11 • 6 weeks. Adverse events were collected from participants while they were in the study, this time frame was 6 weeks.
At each weekly visit, children and their parents met with the investigators and research staff. Parents completed the Response Impressions Side Effects Checklist - Kids (RISK Checklist), a 38-item scale that is rated on a 10-point (0-9) scale ranging from absent to serious.
|
|
General disorders
Hostility
|
66.7%
6/9 • Number of events 18 • 6 weeks. Adverse events were collected from participants while they were in the study, this time frame was 6 weeks.
At each weekly visit, children and their parents met with the investigators and research staff. Parents completed the Response Impressions Side Effects Checklist - Kids (RISK Checklist), a 38-item scale that is rated on a 10-point (0-9) scale ranging from absent to serious.
|
33.3%
3/9 • Number of events 5 • 6 weeks. Adverse events were collected from participants while they were in the study, this time frame was 6 weeks.
At each weekly visit, children and their parents met with the investigators and research staff. Parents completed the Response Impressions Side Effects Checklist - Kids (RISK Checklist), a 38-item scale that is rated on a 10-point (0-9) scale ranging from absent to serious.
|
55.6%
5/9 • Number of events 7 • 6 weeks. Adverse events were collected from participants while they were in the study, this time frame was 6 weeks.
At each weekly visit, children and their parents met with the investigators and research staff. Parents completed the Response Impressions Side Effects Checklist - Kids (RISK Checklist), a 38-item scale that is rated on a 10-point (0-9) scale ranging from absent to serious.
|
|
General disorders
Stomachaches
|
22.2%
2/9 • Number of events 2 • 6 weeks. Adverse events were collected from participants while they were in the study, this time frame was 6 weeks.
At each weekly visit, children and their parents met with the investigators and research staff. Parents completed the Response Impressions Side Effects Checklist - Kids (RISK Checklist), a 38-item scale that is rated on a 10-point (0-9) scale ranging from absent to serious.
|
22.2%
2/9 • Number of events 2 • 6 weeks. Adverse events were collected from participants while they were in the study, this time frame was 6 weeks.
At each weekly visit, children and their parents met with the investigators and research staff. Parents completed the Response Impressions Side Effects Checklist - Kids (RISK Checklist), a 38-item scale that is rated on a 10-point (0-9) scale ranging from absent to serious.
|
0.00%
0/9 • 6 weeks. Adverse events were collected from participants while they were in the study, this time frame was 6 weeks.
At each weekly visit, children and their parents met with the investigators and research staff. Parents completed the Response Impressions Side Effects Checklist - Kids (RISK Checklist), a 38-item scale that is rated on a 10-point (0-9) scale ranging from absent to serious.
|
|
General disorders
Headaches
|
22.2%
2/9 • Number of events 2 • 6 weeks. Adverse events were collected from participants while they were in the study, this time frame was 6 weeks.
At each weekly visit, children and their parents met with the investigators and research staff. Parents completed the Response Impressions Side Effects Checklist - Kids (RISK Checklist), a 38-item scale that is rated on a 10-point (0-9) scale ranging from absent to serious.
|
0.00%
0/9 • 6 weeks. Adverse events were collected from participants while they were in the study, this time frame was 6 weeks.
At each weekly visit, children and their parents met with the investigators and research staff. Parents completed the Response Impressions Side Effects Checklist - Kids (RISK Checklist), a 38-item scale that is rated on a 10-point (0-9) scale ranging from absent to serious.
|
0.00%
0/9 • 6 weeks. Adverse events were collected from participants while they were in the study, this time frame was 6 weeks.
At each weekly visit, children and their parents met with the investigators and research staff. Parents completed the Response Impressions Side Effects Checklist - Kids (RISK Checklist), a 38-item scale that is rated on a 10-point (0-9) scale ranging from absent to serious.
|
|
General disorders
Drowsiness
|
11.1%
1/9 • Number of events 1 • 6 weeks. Adverse events were collected from participants while they were in the study, this time frame was 6 weeks.
At each weekly visit, children and their parents met with the investigators and research staff. Parents completed the Response Impressions Side Effects Checklist - Kids (RISK Checklist), a 38-item scale that is rated on a 10-point (0-9) scale ranging from absent to serious.
|
22.2%
2/9 • Number of events 3 • 6 weeks. Adverse events were collected from participants while they were in the study, this time frame was 6 weeks.
At each weekly visit, children and their parents met with the investigators and research staff. Parents completed the Response Impressions Side Effects Checklist - Kids (RISK Checklist), a 38-item scale that is rated on a 10-point (0-9) scale ranging from absent to serious.
|
33.3%
3/9 • Number of events 3 • 6 weeks. Adverse events were collected from participants while they were in the study, this time frame was 6 weeks.
At each weekly visit, children and their parents met with the investigators and research staff. Parents completed the Response Impressions Side Effects Checklist - Kids (RISK Checklist), a 38-item scale that is rated on a 10-point (0-9) scale ranging from absent to serious.
|
|
General disorders
Sad/Unhappy
|
11.1%
1/9 • Number of events 1 • 6 weeks. Adverse events were collected from participants while they were in the study, this time frame was 6 weeks.
At each weekly visit, children and their parents met with the investigators and research staff. Parents completed the Response Impressions Side Effects Checklist - Kids (RISK Checklist), a 38-item scale that is rated on a 10-point (0-9) scale ranging from absent to serious.
|
11.1%
1/9 • Number of events 1 • 6 weeks. Adverse events were collected from participants while they were in the study, this time frame was 6 weeks.
At each weekly visit, children and their parents met with the investigators and research staff. Parents completed the Response Impressions Side Effects Checklist - Kids (RISK Checklist), a 38-item scale that is rated on a 10-point (0-9) scale ranging from absent to serious.
|
0.00%
0/9 • 6 weeks. Adverse events were collected from participants while they were in the study, this time frame was 6 weeks.
At each weekly visit, children and their parents met with the investigators and research staff. Parents completed the Response Impressions Side Effects Checklist - Kids (RISK Checklist), a 38-item scale that is rated on a 10-point (0-9) scale ranging from absent to serious.
|
|
General disorders
Prone to Crying
|
44.4%
4/9 • Number of events 12 • 6 weeks. Adverse events were collected from participants while they were in the study, this time frame was 6 weeks.
At each weekly visit, children and their parents met with the investigators and research staff. Parents completed the Response Impressions Side Effects Checklist - Kids (RISK Checklist), a 38-item scale that is rated on a 10-point (0-9) scale ranging from absent to serious.
|
33.3%
3/9 • Number of events 8 • 6 weeks. Adverse events were collected from participants while they were in the study, this time frame was 6 weeks.
At each weekly visit, children and their parents met with the investigators and research staff. Parents completed the Response Impressions Side Effects Checklist - Kids (RISK Checklist), a 38-item scale that is rated on a 10-point (0-9) scale ranging from absent to serious.
|
11.1%
1/9 • Number of events 2 • 6 weeks. Adverse events were collected from participants while they were in the study, this time frame was 6 weeks.
At each weekly visit, children and their parents met with the investigators and research staff. Parents completed the Response Impressions Side Effects Checklist - Kids (RISK Checklist), a 38-item scale that is rated on a 10-point (0-9) scale ranging from absent to serious.
|
|
General disorders
Anxious/worries
|
33.3%
3/9 • Number of events 11 • 6 weeks. Adverse events were collected from participants while they were in the study, this time frame was 6 weeks.
At each weekly visit, children and their parents met with the investigators and research staff. Parents completed the Response Impressions Side Effects Checklist - Kids (RISK Checklist), a 38-item scale that is rated on a 10-point (0-9) scale ranging from absent to serious.
|
33.3%
3/9 • Number of events 8 • 6 weeks. Adverse events were collected from participants while they were in the study, this time frame was 6 weeks.
At each weekly visit, children and their parents met with the investigators and research staff. Parents completed the Response Impressions Side Effects Checklist - Kids (RISK Checklist), a 38-item scale that is rated on a 10-point (0-9) scale ranging from absent to serious.
|
22.2%
2/9 • Number of events 2 • 6 weeks. Adverse events were collected from participants while they were in the study, this time frame was 6 weeks.
At each weekly visit, children and their parents met with the investigators and research staff. Parents completed the Response Impressions Side Effects Checklist - Kids (RISK Checklist), a 38-item scale that is rated on a 10-point (0-9) scale ranging from absent to serious.
|
|
General disorders
Bites Fingernails
|
22.2%
2/9 • Number of events 7 • 6 weeks. Adverse events were collected from participants while they were in the study, this time frame was 6 weeks.
At each weekly visit, children and their parents met with the investigators and research staff. Parents completed the Response Impressions Side Effects Checklist - Kids (RISK Checklist), a 38-item scale that is rated on a 10-point (0-9) scale ranging from absent to serious.
|
11.1%
1/9 • Number of events 1 • 6 weeks. Adverse events were collected from participants while they were in the study, this time frame was 6 weeks.
At each weekly visit, children and their parents met with the investigators and research staff. Parents completed the Response Impressions Side Effects Checklist - Kids (RISK Checklist), a 38-item scale that is rated on a 10-point (0-9) scale ranging from absent to serious.
|
11.1%
1/9 • Number of events 1 • 6 weeks. Adverse events were collected from participants while they were in the study, this time frame was 6 weeks.
At each weekly visit, children and their parents met with the investigators and research staff. Parents completed the Response Impressions Side Effects Checklist - Kids (RISK Checklist), a 38-item scale that is rated on a 10-point (0-9) scale ranging from absent to serious.
|
|
General disorders
Picking
|
11.1%
1/9 • Number of events 1 • 6 weeks. Adverse events were collected from participants while they were in the study, this time frame was 6 weeks.
At each weekly visit, children and their parents met with the investigators and research staff. Parents completed the Response Impressions Side Effects Checklist - Kids (RISK Checklist), a 38-item scale that is rated on a 10-point (0-9) scale ranging from absent to serious.
|
11.1%
1/9 • Number of events 1 • 6 weeks. Adverse events were collected from participants while they were in the study, this time frame was 6 weeks.
At each weekly visit, children and their parents met with the investigators and research staff. Parents completed the Response Impressions Side Effects Checklist - Kids (RISK Checklist), a 38-item scale that is rated on a 10-point (0-9) scale ranging from absent to serious.
|
33.3%
3/9 • Number of events 9 • 6 weeks. Adverse events were collected from participants while they were in the study, this time frame was 6 weeks.
At each weekly visit, children and their parents met with the investigators and research staff. Parents completed the Response Impressions Side Effects Checklist - Kids (RISK Checklist), a 38-item scale that is rated on a 10-point (0-9) scale ranging from absent to serious.
|
|
General disorders
Euphoric/Happy
|
33.3%
3/9 • Number of events 4 • 6 weeks. Adverse events were collected from participants while they were in the study, this time frame was 6 weeks.
At each weekly visit, children and their parents met with the investigators and research staff. Parents completed the Response Impressions Side Effects Checklist - Kids (RISK Checklist), a 38-item scale that is rated on a 10-point (0-9) scale ranging from absent to serious.
|
33.3%
3/9 • Number of events 9 • 6 weeks. Adverse events were collected from participants while they were in the study, this time frame was 6 weeks.
At each weekly visit, children and their parents met with the investigators and research staff. Parents completed the Response Impressions Side Effects Checklist - Kids (RISK Checklist), a 38-item scale that is rated on a 10-point (0-9) scale ranging from absent to serious.
|
55.6%
5/9 • Number of events 9 • 6 weeks. Adverse events were collected from participants while they were in the study, this time frame was 6 weeks.
At each weekly visit, children and their parents met with the investigators and research staff. Parents completed the Response Impressions Side Effects Checklist - Kids (RISK Checklist), a 38-item scale that is rated on a 10-point (0-9) scale ranging from absent to serious.
|
|
General disorders
Nausea
|
11.1%
1/9 • Number of events 1 • 6 weeks. Adverse events were collected from participants while they were in the study, this time frame was 6 weeks.
At each weekly visit, children and their parents met with the investigators and research staff. Parents completed the Response Impressions Side Effects Checklist - Kids (RISK Checklist), a 38-item scale that is rated on a 10-point (0-9) scale ranging from absent to serious.
|
22.2%
2/9 • Number of events 2 • 6 weeks. Adverse events were collected from participants while they were in the study, this time frame was 6 weeks.
At each weekly visit, children and their parents met with the investigators and research staff. Parents completed the Response Impressions Side Effects Checklist - Kids (RISK Checklist), a 38-item scale that is rated on a 10-point (0-9) scale ranging from absent to serious.
|
0.00%
0/9 • 6 weeks. Adverse events were collected from participants while they were in the study, this time frame was 6 weeks.
At each weekly visit, children and their parents met with the investigators and research staff. Parents completed the Response Impressions Side Effects Checklist - Kids (RISK Checklist), a 38-item scale that is rated on a 10-point (0-9) scale ranging from absent to serious.
|
|
Psychiatric disorders
Tics
|
22.2%
2/9 • Number of events 8 • 6 weeks. Adverse events were collected from participants while they were in the study, this time frame was 6 weeks.
At each weekly visit, children and their parents met with the investigators and research staff. Parents completed the Response Impressions Side Effects Checklist - Kids (RISK Checklist), a 38-item scale that is rated on a 10-point (0-9) scale ranging from absent to serious.
|
22.2%
2/9 • Number of events 3 • 6 weeks. Adverse events were collected from participants while they were in the study, this time frame was 6 weeks.
At each weekly visit, children and their parents met with the investigators and research staff. Parents completed the Response Impressions Side Effects Checklist - Kids (RISK Checklist), a 38-item scale that is rated on a 10-point (0-9) scale ranging from absent to serious.
|
33.3%
3/9 • Number of events 4 • 6 weeks. Adverse events were collected from participants while they were in the study, this time frame was 6 weeks.
At each weekly visit, children and their parents met with the investigators and research staff. Parents completed the Response Impressions Side Effects Checklist - Kids (RISK Checklist), a 38-item scale that is rated on a 10-point (0-9) scale ranging from absent to serious.
|
|
General disorders
Jittery or nervous
|
22.2%
2/9 • Number of events 6 • 6 weeks. Adverse events were collected from participants while they were in the study, this time frame was 6 weeks.
At each weekly visit, children and their parents met with the investigators and research staff. Parents completed the Response Impressions Side Effects Checklist - Kids (RISK Checklist), a 38-item scale that is rated on a 10-point (0-9) scale ranging from absent to serious.
|
22.2%
2/9 • Number of events 4 • 6 weeks. Adverse events were collected from participants while they were in the study, this time frame was 6 weeks.
At each weekly visit, children and their parents met with the investigators and research staff. Parents completed the Response Impressions Side Effects Checklist - Kids (RISK Checklist), a 38-item scale that is rated on a 10-point (0-9) scale ranging from absent to serious.
|
11.1%
1/9 • Number of events 1 • 6 weeks. Adverse events were collected from participants while they were in the study, this time frame was 6 weeks.
At each weekly visit, children and their parents met with the investigators and research staff. Parents completed the Response Impressions Side Effects Checklist - Kids (RISK Checklist), a 38-item scale that is rated on a 10-point (0-9) scale ranging from absent to serious.
|
|
General disorders
Mood Swings/Lability
|
55.6%
5/9 • Number of events 17 • 6 weeks. Adverse events were collected from participants while they were in the study, this time frame was 6 weeks.
At each weekly visit, children and their parents met with the investigators and research staff. Parents completed the Response Impressions Side Effects Checklist - Kids (RISK Checklist), a 38-item scale that is rated on a 10-point (0-9) scale ranging from absent to serious.
|
33.3%
3/9 • Number of events 5 • 6 weeks. Adverse events were collected from participants while they were in the study, this time frame was 6 weeks.
At each weekly visit, children and their parents met with the investigators and research staff. Parents completed the Response Impressions Side Effects Checklist - Kids (RISK Checklist), a 38-item scale that is rated on a 10-point (0-9) scale ranging from absent to serious.
|
33.3%
3/9 • Number of events 5 • 6 weeks. Adverse events were collected from participants while they were in the study, this time frame was 6 weeks.
At each weekly visit, children and their parents met with the investigators and research staff. Parents completed the Response Impressions Side Effects Checklist - Kids (RISK Checklist), a 38-item scale that is rated on a 10-point (0-9) scale ranging from absent to serious.
|
|
General disorders
Fatigue
|
11.1%
1/9 • Number of events 1 • 6 weeks. Adverse events were collected from participants while they were in the study, this time frame was 6 weeks.
At each weekly visit, children and their parents met with the investigators and research staff. Parents completed the Response Impressions Side Effects Checklist - Kids (RISK Checklist), a 38-item scale that is rated on a 10-point (0-9) scale ranging from absent to serious.
|
22.2%
2/9 • Number of events 2 • 6 weeks. Adverse events were collected from participants while they were in the study, this time frame was 6 weeks.
At each weekly visit, children and their parents met with the investigators and research staff. Parents completed the Response Impressions Side Effects Checklist - Kids (RISK Checklist), a 38-item scale that is rated on a 10-point (0-9) scale ranging from absent to serious.
|
11.1%
1/9 • Number of events 3 • 6 weeks. Adverse events were collected from participants while they were in the study, this time frame was 6 weeks.
At each weekly visit, children and their parents met with the investigators and research staff. Parents completed the Response Impressions Side Effects Checklist - Kids (RISK Checklist), a 38-item scale that is rated on a 10-point (0-9) scale ranging from absent to serious.
|
|
Gastrointestinal disorders
Constipation
|
22.2%
2/9 • Number of events 7 • 6 weeks. Adverse events were collected from participants while they were in the study, this time frame was 6 weeks.
At each weekly visit, children and their parents met with the investigators and research staff. Parents completed the Response Impressions Side Effects Checklist - Kids (RISK Checklist), a 38-item scale that is rated on a 10-point (0-9) scale ranging from absent to serious.
|
33.3%
3/9 • Number of events 9 • 6 weeks. Adverse events were collected from participants while they were in the study, this time frame was 6 weeks.
At each weekly visit, children and their parents met with the investigators and research staff. Parents completed the Response Impressions Side Effects Checklist - Kids (RISK Checklist), a 38-item scale that is rated on a 10-point (0-9) scale ranging from absent to serious.
|
0.00%
0/9 • 6 weeks. Adverse events were collected from participants while they were in the study, this time frame was 6 weeks.
At each weekly visit, children and their parents met with the investigators and research staff. Parents completed the Response Impressions Side Effects Checklist - Kids (RISK Checklist), a 38-item scale that is rated on a 10-point (0-9) scale ranging from absent to serious.
|
|
General disorders
Stares A Lot
|
0.00%
0/9 • 6 weeks. Adverse events were collected from participants while they were in the study, this time frame was 6 weeks.
At each weekly visit, children and their parents met with the investigators and research staff. Parents completed the Response Impressions Side Effects Checklist - Kids (RISK Checklist), a 38-item scale that is rated on a 10-point (0-9) scale ranging from absent to serious.
|
22.2%
2/9 • Number of events 2 • 6 weeks. Adverse events were collected from participants while they were in the study, this time frame was 6 weeks.
At each weekly visit, children and their parents met with the investigators and research staff. Parents completed the Response Impressions Side Effects Checklist - Kids (RISK Checklist), a 38-item scale that is rated on a 10-point (0-9) scale ranging from absent to serious.
|
33.3%
3/9 • Number of events 3 • 6 weeks. Adverse events were collected from participants while they were in the study, this time frame was 6 weeks.
At each weekly visit, children and their parents met with the investigators and research staff. Parents completed the Response Impressions Side Effects Checklist - Kids (RISK Checklist), a 38-item scale that is rated on a 10-point (0-9) scale ranging from absent to serious.
|
|
General disorders
Abdominal pain
|
0.00%
0/9 • 6 weeks. Adverse events were collected from participants while they were in the study, this time frame was 6 weeks.
At each weekly visit, children and their parents met with the investigators and research staff. Parents completed the Response Impressions Side Effects Checklist - Kids (RISK Checklist), a 38-item scale that is rated on a 10-point (0-9) scale ranging from absent to serious.
|
11.1%
1/9 • Number of events 1 • 6 weeks. Adverse events were collected from participants while they were in the study, this time frame was 6 weeks.
At each weekly visit, children and their parents met with the investigators and research staff. Parents completed the Response Impressions Side Effects Checklist - Kids (RISK Checklist), a 38-item scale that is rated on a 10-point (0-9) scale ranging from absent to serious.
|
0.00%
0/9 • 6 weeks. Adverse events were collected from participants while they were in the study, this time frame was 6 weeks.
At each weekly visit, children and their parents met with the investigators and research staff. Parents completed the Response Impressions Side Effects Checklist - Kids (RISK Checklist), a 38-item scale that is rated on a 10-point (0-9) scale ranging from absent to serious.
|
|
General disorders
Rash
|
0.00%
0/9 • 6 weeks. Adverse events were collected from participants while they were in the study, this time frame was 6 weeks.
At each weekly visit, children and their parents met with the investigators and research staff. Parents completed the Response Impressions Side Effects Checklist - Kids (RISK Checklist), a 38-item scale that is rated on a 10-point (0-9) scale ranging from absent to serious.
|
11.1%
1/9 • Number of events 1 • 6 weeks. Adverse events were collected from participants while they were in the study, this time frame was 6 weeks.
At each weekly visit, children and their parents met with the investigators and research staff. Parents completed the Response Impressions Side Effects Checklist - Kids (RISK Checklist), a 38-item scale that is rated on a 10-point (0-9) scale ranging from absent to serious.
|
33.3%
3/9 • Number of events 9 • 6 weeks. Adverse events were collected from participants while they were in the study, this time frame was 6 weeks.
At each weekly visit, children and their parents met with the investigators and research staff. Parents completed the Response Impressions Side Effects Checklist - Kids (RISK Checklist), a 38-item scale that is rated on a 10-point (0-9) scale ranging from absent to serious.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/9 • 6 weeks. Adverse events were collected from participants while they were in the study, this time frame was 6 weeks.
At each weekly visit, children and their parents met with the investigators and research staff. Parents completed the Response Impressions Side Effects Checklist - Kids (RISK Checklist), a 38-item scale that is rated on a 10-point (0-9) scale ranging from absent to serious.
|
11.1%
1/9 • Number of events 1 • 6 weeks. Adverse events were collected from participants while they were in the study, this time frame was 6 weeks.
At each weekly visit, children and their parents met with the investigators and research staff. Parents completed the Response Impressions Side Effects Checklist - Kids (RISK Checklist), a 38-item scale that is rated on a 10-point (0-9) scale ranging from absent to serious.
|
0.00%
0/9 • 6 weeks. Adverse events were collected from participants while they were in the study, this time frame was 6 weeks.
At each weekly visit, children and their parents met with the investigators and research staff. Parents completed the Response Impressions Side Effects Checklist - Kids (RISK Checklist), a 38-item scale that is rated on a 10-point (0-9) scale ranging from absent to serious.
|
|
General disorders
Cold Hands and Feet
|
0.00%
0/9 • 6 weeks. Adverse events were collected from participants while they were in the study, this time frame was 6 weeks.
At each weekly visit, children and their parents met with the investigators and research staff. Parents completed the Response Impressions Side Effects Checklist - Kids (RISK Checklist), a 38-item scale that is rated on a 10-point (0-9) scale ranging from absent to serious.
|
0.00%
0/9 • 6 weeks. Adverse events were collected from participants while they were in the study, this time frame was 6 weeks.
At each weekly visit, children and their parents met with the investigators and research staff. Parents completed the Response Impressions Side Effects Checklist - Kids (RISK Checklist), a 38-item scale that is rated on a 10-point (0-9) scale ranging from absent to serious.
|
11.1%
1/9 • Number of events 1 • 6 weeks. Adverse events were collected from participants while they were in the study, this time frame was 6 weeks.
At each weekly visit, children and their parents met with the investigators and research staff. Parents completed the Response Impressions Side Effects Checklist - Kids (RISK Checklist), a 38-item scale that is rated on a 10-point (0-9) scale ranging from absent to serious.
|
Additional Information
Dr. Mark Stein
Dept. of Psychiatry, University of Washington
Phone: 206-987-1161
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place