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Dose Response Effects of Quillivant XR in Children With ADHD and Autism: A Pilot Study

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ClinicalTrials.gov Identifier: NCT02255565
Recruitment Status : Completed
First Posted : October 2, 2014
Results First Posted : June 5, 2017
Last Update Posted : August 1, 2017
Sponsor:
Collaborator:
Pfizer
Information provided by (Responsible Party):
Mark Stein, Seattle Children's Hospital

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Outcomes Assessor);   Primary Purpose: Treatment
Conditions ADHD
Autism
Interventions Drug: Very Low Dose Quillivant XR
Drug: Low Dose Quillivant XR
Drug: Moderate Dose Quillivant XR
Enrollment 36
Recruitment Details Eligible participants were recruited from the investigators' practices, clinic referrals, and letter mailings. Participants were enrolled between September 2014 and September 2016.
Pre-assignment Details 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.
Arm/Group Title Very Low Dose Quillivant XR Low Dose Quillivant XR Moderate Dose Quillivant XR
Hide Arm/Group Description

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

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

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

Period Title: Overall Study
Started 9 9 9
Completed 9 8 9
Not Completed 0 1 0
Reason Not Completed
Withdrawal by Subject             0             1             0
Arm/Group Title Very Low Dose Quillivant XR Low Dose Quillivant XR Moderate Dose Quillivant XR Total
Hide Arm/Group Description

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

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

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 of all reporting groups
Overall Number of Baseline Participants 9 9 9 27
Hide Baseline Analysis Population Description
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.
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 9 participants 9 participants 9 participants 27 participants
<=18 years
9
 100.0%
9
 100.0%
9
 100.0%
27
 100.0%
Between 18 and 65 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 9 participants 9 participants 9 participants 27 participants
9.33  (2.92) 8.00  (2.96) 10.22  (3.03) 9.19  (3.00)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 9 participants 9 participants 9 participants 27 participants
Female
1
  11.1%
0
   0.0%
1
  11.1%
2
   7.4%
Male
8
  88.9%
9
 100.0%
8
  88.9%
25
  92.6%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 9 participants 9 participants 9 participants 27 participants
9 9 9 26
1.Primary Outcome
Title ADHD Rating Scale - IV
Hide Description 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.
Time Frame once a week for 6 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Very Low Dose Quillivant XR - Week 1 Very Low Dose Quillivant XR - Week 2 Very Low Dose Quillivant XR - Week 3 Very Low Dose Quillivant XR - Week 4 Very Low Dose Quillivant XR - Week 5 Very Low Dose Quillivant XR - Week 6 Low Dose Quillivant XR - Week 1 Low Dose Quillivant XR - Week 2 Low Dose Quillivant XR - Week 3 Low Dose Quillivant XR - Week 4 Low Dose Quillivant XR - Week 5 Low Dose Quillivant XR - Week 6 Moderate Dose Quillivant XR - Week 1 Moderate Dose Quillivant XR - Week 2 Moderate Dose Quillivant XR - Week 3 Moderate Dose Quillivant XR - Week 4 Moderate Dose Quillivant XR - Week 5 Moderate Dose Quillivant XR - Week 6
Hide Arm/Group Description:

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

Overall Number of Participants Analyzed 9 9 9 9 9 9 9 9 9 8 8 9 9 9 9 9 9 9
Mean (Standard Deviation)
Unit of Measure: units on a scale
Inattention Subscale Score 17.89  (3.95) 16.78  (4.18) 16.67  (2.74) 14.33  (6.26) 14.56  (5.53) 12.89  (5.01) 16.33  (6.89) 14.00  (5.83) 12.00  (5.22) 8.38  (5.90) 9.50  (4.57) 9.56  (6.17) 18.11  (4.43) 14.67  (5.15) 13.67  (6.98) 13.56  (5.10) 13.00  (5.55) 11.78  (5.43)
Hyperactivity Subscale Score 12.44  (7.91) 10.56  (8.16) 11.56  (6.25) 12.33  (5.70) 9.22  (7.55) 8.78  (5.67) 15.33  (8.23) 14.33  (7.38) 10.22  (5.24) 6.88  (4.42) 9.38  (4.75) 6.56  (4.28) 12.78  (3.87) 11.33  (2.78) 11.78  (6.26) 9.67  (5.87) 9.22  (5.83) 7.33  (2.87)
Total Score 30.33  (9.27) 27.33  (11.14) 28.22  (7.24) 26.67  (10.20) 23.78  (11.51) 21.67  (7.78) 31.67  (14.67) 28.33  (12.41) 22.22  (9.90) 15.25  (9.77) 18.88  (9.06) 16.11  (8.99) 30.89  (6.17) 26.00  (5.87) 25.44  (12.70) 23.22  (10.02) 22.22  (10.03) 19.11  (7.44)
2.Secondary Outcome
Title Clinical Global Impressions-ADHD - Severity
Hide Description The 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.
Time Frame once a week for 6 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Very Low Dose Quillivant XR - Week 1 Very Low Dose Quillivant XR - Week 2 Very Low Dose Quillivant XR - Week 3 Very Low Dose Quillivant XR - Week 4 Very Low Dose Quillivant XR - Week 5 Very Low Dose Quillivant XR - Week 6 Low Dose Quillivant XR - Week 1 Low Dose Quillivant XR - Week 2 Low Dose Quillivant XR - Week 3 Low Dose Quillivant XR - Week 4 Low Dose Quillivant XR - Week 5 Low Dose Quillivant XR - Week 6 Moderate Dose Quillivant XR - Week 1 Moderate Dose Quillivant XR - Week 2 Moderate Dose Quillivant XR - Week 3 Moderate Dose Quillivant XR - Week 4 Moderate Dose Quillivant XR - Week 5 Moderate Dose Quillivant XR - Week 6
Hide Arm/Group Description:

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

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

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

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

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

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

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

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

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

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

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

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

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 40mg dose

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 40mg dose

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 40mg dose

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 40mg dose

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 40mg dose

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 40mg dose

Overall Number of Participants Analyzed 9 9 9 9 9 9 9 9 9 8 8 9 9 9 9 9 9 9
Mean (Standard Deviation)
Unit of Measure: units on a scale
4.78  (0.44) 4.33  (0.87) 4.44  (0.88) 4.33  (0.87) 4.11  (1.05) 4.00  (0.87) 4.33  (1.12) 4.00  (1.22) 3.67  (1.00) 2.75  (1.16) 2.88  (1.25) 2.78  (1.30) 4.89  (0.33) 4.56  (0.53) 4.11  (0.60) 4.00  (0.71) 3.56  (0.88) 3.44  (1.24)
3.Secondary Outcome
Title Clinical Global Impression - Improvement (CGI-I)
Hide Description The 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.
Time Frame once a week for 6 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Very Low Dose Quillivant XR - Week 1 Very Low Dose Quillivant XR - Week 2 Very Low Dose Quillivant XR - Week 3 Very Low Dose Quillivant XR - Week 4 Very Low Dose Quillivant XR - Week 5 Very Low Dose Quillivant XR - Week 6 Low Dose Quillivant XR - Week 1 Low Dose Quillivant XR - Week 2 Low Dose Quillivant XR - Week 3 Low Dose Quillivant XR - Week 4 Low Dose Quillivant XR - Week 5 Low Dose Quillivant XR - Week 6 Moderate Dose Quillivant XR - Week 1 Moderate Dose Quillivant XR - Week 2 Moderate Dose Quillivant XR - Week 3 Moderate Dose Quillivant XR - Week 4 Moderate Dose Quillivant XR - Week 5 Moderate Dose Quillivant XR - Week 6
Hide Arm/Group Description:

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 10mg dose

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 10mg dose

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 10mg dose

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 10mg dose

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 10mg dose

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 10mg dose

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

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

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

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

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

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

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 40mg dose

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 40mg dose

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 40mg dose

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 40mg dose

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 40mg dose

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 40mg dose

Overall Number of Participants Analyzed 9 9 9 9 9 9 9 9 9 8 8 9 9 9 9 9 9 9
Mean (Standard Deviation)
Unit of Measure: units on a scale
3.89  (0.60) 3.56  (0.88) 3.44  (0.53) 3.22  (0.83) 3.00  (1.00) 2.89  (0.78) 3.78  (1.30) 3.00  (0.87) 2.22  (0.83) 1.63  (0.74) 2.13  (0.99) 2.00  (0.87) 3.33  (0.50) 3.11  (0.60) 2.67  (1.12) 2.89  (0.60) 2.56  (1.01) 2.22  (0.83)
Time Frame 6 weeks. Adverse events were collected from participants while they were in the study, this time frame was 6 weeks.
Adverse Event Reporting Description 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.
 
Arm/Group Title Very Low Dose Quillivant XR Low Dose Quillivant XR Moderate Dose Quillivant XR
Hide Arm/Group Description

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

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

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

All-Cause Mortality
Very Low Dose Quillivant XR Low Dose Quillivant XR Moderate Dose Quillivant XR
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Very Low Dose Quillivant XR Low Dose Quillivant XR Moderate Dose Quillivant XR
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/9 (0.00%)      0/9 (0.00%)      0/9 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Very Low Dose Quillivant XR Low Dose Quillivant XR Moderate Dose Quillivant XR
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   8/9 (88.89%)      8/9 (88.89%)      9/9 (100.00%)    
Gastrointestinal disorders       
Constipation  1 [1]  2/9 (22.22%)  7 3/9 (33.33%)  9 0/9 (0.00%)  0
Vomiting  1 [2]  0/9 (0.00%)  0 1/9 (11.11%)  1 0/9 (0.00%)  0
General disorders       
Difficulty Falling Asleep  1  5/9 (55.56%)  17 6/9 (66.67%)  10 6/9 (66.67%)  17
Waking at Night  1 [3]  2/9 (22.22%)  2 2/9 (22.22%)  5 1/9 (11.11%)  1
Waking up Early  1 [4]  3/9 (33.33%)  9 5/9 (55.56%)  16 2/9 (22.22%)  5
Nightmares  1 [5]  1/9 (11.11%)  1 0/9 (0.00%)  0 1/9 (11.11%)  1
Talks less  1 [6]  2/9 (22.22%)  3 1/9 (11.11%)  1 2/9 (22.22%)  2
Uninterested  1 [7]  2/9 (22.22%)  7 1/9 (11.11%)  1 4/9 (44.44%)  5
Decreased Appetite  1 [8]  3/9 (33.33%)  9 6/9 (66.67%)  13 4/9 (44.44%)  13
Irritable  1 [9]  7/9 (77.78%)  22 4/9 (44.44%)  6 4/9 (44.44%)  11
Hostility  1 [10]  6/9 (66.67%)  18 3/9 (33.33%)  5 5/9 (55.56%)  7
Stomachaches  1 [11]  2/9 (22.22%)  2 2/9 (22.22%)  2 0/9 (0.00%)  0
Headaches  1 [12]  2/9 (22.22%)  2 0/9 (0.00%)  0 0/9 (0.00%)  0
Drowsiness  1 [13]  1/9 (11.11%)  1 2/9 (22.22%)  3 3/9 (33.33%)  3
Sad/Unhappy  1 [14]  1/9 (11.11%)  1 1/9 (11.11%)  1 0/9 (0.00%)  0
Prone to Crying  1 [15]  4/9 (44.44%)  12 3/9 (33.33%)  8 1/9 (11.11%)  2
Anxious/worries  1 [16]  3/9 (33.33%)  11 3/9 (33.33%)  8 2/9 (22.22%)  2
Bites Fingernails  1 [17]  2/9 (22.22%)  7 1/9 (11.11%)  1 1/9 (11.11%)  1
Picking  1 [18]  1/9 (11.11%)  1 1/9 (11.11%)  1 3/9 (33.33%)  9
Euphoric/Happy  1 [19]  3/9 (33.33%)  4 3/9 (33.33%)  9 5/9 (55.56%)  9
Nausea  1 [20]  1/9 (11.11%)  1 2/9 (22.22%)  2 0/9 (0.00%)  0
Jittery or nervous  1 [21]  2/9 (22.22%)  6 2/9 (22.22%)  4 1/9 (11.11%)  1
Mood Swings/Lability  1 [22]  5/9 (55.56%)  17 3/9 (33.33%)  5 3/9 (33.33%)  5
Fatigue  1 [23]  1/9 (11.11%)  1 2/9 (22.22%)  2 1/9 (11.11%)  3
Stares A Lot  1 [24]  0/9 (0.00%)  0 2/9 (22.22%)  2 3/9 (33.33%)  3
Abdominal pain  1 [25]  0/9 (0.00%)  0 1/9 (11.11%)  1 0/9 (0.00%)  0
Rash  1 [26]  0/9 (0.00%)  0 1/9 (11.11%)  1 3/9 (33.33%)  9
Cold Hands and Feet  1 [27]  0/9 (0.00%)  0 0/9 (0.00%)  0 1/9 (11.11%)  1
Psychiatric disorders       
Flat Affect / No Emotion  1 [28]  2/9 (22.22%)  3 0/9 (0.00%)  0 2/9 (22.22%)  2
Rebound at end of day  1 [29]  4/9 (44.44%)  16 4/9 (44.44%)  19 5/9 (55.56%)  15
Aggression  1 [30]  6/9 (66.67%)  16 2/9 (22.22%)  5 4/9 (44.44%)  7
Tics  1 [31]  2/9 (22.22%)  8 2/9 (22.22%)  3 3/9 (33.33%)  4
Indicates events were collected by systematic assessment
1
Term from vocabulary, RISK
[1]
Infrequent bowel movements
[2]
Throwing up
[3]
Difficulty remaining asleep throughout the night
[4]
Premature awakening in the morning, is too alert to resume sleeping after waking
[5]
Distressing dreams
[6]
Child talks less than is normal for him/her.
[7]
Child appears not to be interested in things or people around him/her
[8]
Reduction in the intensity or frequency of hunger; a reduced desire to eat
[9]
Easily irritated or annoyed
[10]
Showing antagonism and opposition towards people and/or circumstances
[11]
Persistent pain localized in the stomach area
[12]
Persistent physical pain in the child's head
[13]
An irresistible urge to fall asleep at inappropriate times
[14]
Child appears inappropriately sad (moods is not congruent with setting or circumstance)
[15]
Cries easily or often
[16]
Apprehension, fear, concern, or dread
[17]
Child bites fingernails or cuticles
[18]
Child picks at skin, cuticles, fingernails, etc.
[19]
Child appears inappropriately happy (mood is not congruent with setting or circumstance)
[20]
The urge to vomit; child feels like he/she might vomit
[21]
An edgy, tense state; is easily agitated or anxious
[22]
Unpredictable or easily changeable moods; unstable moods or emotions
[23]
A reduction of strength or energy
[24]
Child frequently has a fixed look with his/her wide open, looks into space
[25]
Persistent pain localized in the abdomen
[26]
Skin becomes reddened, itchy, and/or raised (not due to an insect bite)
[27]
Hands and feet are cold to the touch
[28]
Complete (or nearly complete) absence of emotional expression.
[29]
An intensification of ADHD symptoms at the end of the day
[30]
Behaving in an actively hostile manner
[31]
Child makes repetitive, uncontrollable movements or sounds
No placebo was available for comparison to Quillivant XR. Small sample size.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Mark Stein
Organization: Dept. of Psychiatry, University of Washington
Phone: 206-987-1161
EMail: mstein42@uw.edu
Layout table for additonal information
Responsible Party: Mark Stein, Seattle Children's Hospital
ClinicalTrials.gov Identifier: NCT02255565     History of Changes
Other Study ID Numbers: WI185890
First Submitted: September 24, 2014
First Posted: October 2, 2014
Results First Submitted: March 7, 2017
Results First Posted: June 5, 2017
Last Update Posted: August 1, 2017