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| Name | Class |
|---|---|
| Pfizer | INDUSTRY |
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The purpose of this study is to determine whether Quillivant XR is effective in the treatment of ADHD in children with Autism Spectrum Disorder (ASD).
To evaluate the safety and tolerability of low to moderate dose effects of Quillivant XR (liquid methylphenidate) and to observe changes in ADHD symptoms and functional outcomes in children with ASD and ADHD. The investigators propose to investigate the low to moderate dose range of methylphenidate compared with a very low dose with a gradual dose escalation schedule because children with ASD have been found to be more sensitive to the adverse effects of methylphenidate (especially in medium to high doses) than children without ASD.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Very Low Dose Quillivant XR | Experimental | Patients in this treatment arm are given Quillivant XR (a liquid medication) to treat ADHD at a very low dose level for 6 weeks. |
|
| Low Dose Quillivant XR | Experimental | Patients in this treatment arm are given Quillivant XR (a liquid medication) to treat ADHD at a low dose level for 6 weeks. |
|
| Moderate dose Quillivant XR | Experimental | Patients in this treatment arm are given Quillivant XR (a liquid medication) to treat ADHD at a moderate dose level for 6 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Very Low Dose Quillivant XR | Drug | Oral suspension dose once a day increasing to a 10mg dose |
|
| Measure | Description | Time Frame |
|---|---|---|
| ADHD Rating Scale - IV | 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. | once a week for 6 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical Global Impressions-ADHD - Severity | 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. | once a week for 6 weeks |
| Clinical Global Impression - Improvement (CGI-I) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mark Stein, PhD | Seattle Children's Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Seattle Children's Hospital | Seattle | Washington | 98105 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 16477513 | Background | Gadow KD, DeVincent CJ, Pomeroy J. ADHD symptom subtypes in children with pervasive developmental disorder. J Autism Dev Disord. 2006 Feb;36(2):271-83. doi: 10.1007/s10803-005-0060-3. | |
| 17201617 | Background | Lee DO, Ousley OY. Attention-deficit hyperactivity disorder symptoms in a clinic sample of children and adolescents with pervasive developmental disorders. J Child Adolesc Psychopharmacol. 2006 Dec;16(6):737-46. doi: 10.1089/cap.2006.16.737. |
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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.
Eligible participants were recruited from the investigators' practices, clinic referrals, and letter mailings. Participants were enrolled between September 2014 and September 2016.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| FG001 | 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 |
| FG002 | 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 |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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.
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| BG001 | Low Dose Quillivant XR |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | ADHD Rating Scale - IV | 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. | Posted | Mean | Standard Deviation | units on a scale | once a week for 6 weeks |
|
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.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Difficulty Falling Asleep | General disorders | RISK | Systematic Assessment |
No placebo was available for comparison to Quillivant XR. Small sample size.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Mark Stein | Dept. of Psychiatry, University of Washington | 206-987-1161 | mstein42@uw.edu |
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| ID | Term |
|---|---|
| D001289 | Attention Deficit Disorder with Hyperactivity |
| D001321 | Autistic Disorder |
| ID | Term |
|---|---|
| D019958 | Attention Deficit and Disruptive Behavior Disorders |
| D065886 | Neurodevelopmental Disorders |
| D001523 | Mental Disorders |
| D000067877 | Autism Spectrum Disorder |
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| ID | Term |
|---|---|
| D008774 | Methylphenidate |
| ID | Term |
|---|---|
| D010648 | Phenylacetates |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
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| Low Dose Quillivant XR | Drug | Oral suspension dose once a day increasing to a 20mg dose |
|
|
| Moderate Dose Quillivant XR | Drug | Oral suspension dose once a day increasing to a 40mg dose |
|
|
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. |
| once a week for 6 weeks |
| Background | Rao, P. A. and R. J. Landa (2013). |
| 16275814 | Background | Research Units on Pediatric Psychopharmacology Autism Network. Randomized, controlled, crossover trial of methylphenidate in pervasive developmental disorders with hyperactivity. Arch Gen Psychiatry. 2005 Nov;62(11):1266-74. doi: 10.1001/archpsyc.62.11.1266. |
| Background | Stein, M.A. et al. |
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 |
| BG002 | 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 |
| BG003 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 | Very Low Dose Quillivant XR - Week 2 | 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 |
| OG002 | Very Low Dose Quillivant XR - Week 3 | 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 |
| OG003 | Very Low Dose Quillivant XR - Week 4 | 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 |
| OG004 | Very Low Dose Quillivant XR - Week 5 | 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 |
| OG005 | Very Low Dose Quillivant XR - Week 6 | 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 |
| OG006 | Low Dose Quillivant XR - Week 1 | 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 |
| OG007 | Low Dose Quillivant XR - Week 2 | 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 |
| OG008 | Low Dose Quillivant XR - Week 3 | 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 |
| OG009 | Low Dose Quillivant XR - Week 4 | 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 |
| OG010 | Low Dose Quillivant XR - Week 5 | 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 |
| OG011 | Low Dose Quillivant XR - Week 6 | 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 |
| OG012 | Moderate Dose Quillivant XR - Week 1 | 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 |
| OG013 | Moderate Dose Quillivant XR - Week 2 | 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 |
| OG014 | Moderate Dose Quillivant XR - Week 3 | 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 |
| OG015 | Moderate Dose Quillivant XR - Week 4 | 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 |
| OG016 | Moderate Dose Quillivant XR - Week 5 | 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 |
| OG017 | Moderate Dose Quillivant XR - Week 6 | 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 |
|
|
| Secondary | Clinical Global Impressions-ADHD - Severity | 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. | Posted | Mean | Standard Deviation | units on a scale | once a week for 6 weeks |
|
|
|
| Secondary | Clinical Global Impression - Improvement (CGI-I) | 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. | Posted | Mean | Standard Deviation | units on a scale | once a week for 6 weeks |
|
|
|
| 0 |
| 9 |
| 8 |
| 9 |
| EG001 | 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 | 0 | 9 | 8 | 9 |
| EG002 | 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 | 0 | 9 | 9 | 9 |
| Waking at Night | General disorders | RISK | Systematic Assessment | Difficulty remaining asleep throughout the night |
|
| Waking up Early | General disorders | RISK | Systematic Assessment | Premature awakening in the morning, is too alert to resume sleeping after waking |
|
| Nightmares | General disorders | RISK | Systematic Assessment | Distressing dreams |
|
| Flat Affect / No Emotion | Psychiatric disorders | RISK | Systematic Assessment | Complete (or nearly complete) absence of emotional expression. |
|
| Rebound at end of day | Psychiatric disorders | RISK | Systematic Assessment | An intensification of ADHD symptoms at the end of the day |
|
| Aggression | Psychiatric disorders | RISK | Systematic Assessment | Behaving in an actively hostile manner |
|
| Talks less | General disorders | RISK | Systematic Assessment | Child talks less than is normal for him/her. |
|
| Uninterested | General disorders | RISK | Systematic Assessment | Child appears not to be interested in things or people around him/her |
|
| Decreased Appetite | General disorders | RISK | Systematic Assessment | Reduction in the intensity or frequency of hunger; a reduced desire to eat |
|
| Irritable | General disorders | RISK | Systematic Assessment | Easily irritated or annoyed |
|
| Hostility | General disorders | RISK | Systematic Assessment | Showing antagonism and opposition towards people and/or circumstances |
|
| Stomachaches | General disorders | RISK | Systematic Assessment | Persistent pain localized in the stomach area |
|
| Headaches | General disorders | RISK | Systematic Assessment | Persistent physical pain in the child's head |
|
| Drowsiness | General disorders | RISK | Systematic Assessment | An irresistible urge to fall asleep at inappropriate times |
|
| Sad/Unhappy | General disorders | RISK | Systematic Assessment | Child appears inappropriately sad (moods is not congruent with setting or circumstance) |
|
| Prone to Crying | General disorders | RISK | Systematic Assessment | Cries easily or often |
|
| Anxious/worries | General disorders | RISK | Systematic Assessment | Apprehension, fear, concern, or dread |
|
| Bites Fingernails | General disorders | RISK | Systematic Assessment | Child bites fingernails or cuticles |
|
| Picking | General disorders | RISK | Systematic Assessment | Child picks at skin, cuticles, fingernails, etc. |
|
| Euphoric/Happy | General disorders | RISK | Systematic Assessment | Child appears inappropriately happy (mood is not congruent with setting or circumstance) |
|
| Nausea | General disorders | RISK | Systematic Assessment | The urge to vomit; child feels like he/she might vomit |
|
| Tics | Psychiatric disorders | RISK | Systematic Assessment | Child makes repetitive, uncontrollable movements or sounds |
|
| Jittery or nervous | General disorders | RISK | Systematic Assessment | An edgy, tense state; is easily agitated or anxious |
|
| Mood Swings/Lability | General disorders | RISK | Systematic Assessment | Unpredictable or easily changeable moods; unstable moods or emotions |
|
| Fatigue | General disorders | RISK | Systematic Assessment | A reduction of strength or energy |
|
| Constipation | Gastrointestinal disorders | RISK | Systematic Assessment | Infrequent bowel movements |
|
| Stares A Lot | General disorders | RISK | Systematic Assessment | Child frequently has a fixed look with his/her wide open, looks into space |
|
| Abdominal pain | General disorders | RISK | Systematic Assessment | Persistent pain localized in the abdomen |
|
| Rash | General disorders | RISK | Systematic Assessment | Skin becomes reddened, itchy, and/or raised (not due to an insect bite) |
|
| Vomiting | Gastrointestinal disorders | RISK | Systematic Assessment | Throwing up |
|
| Cold Hands and Feet | General disorders | RISK | Systematic Assessment | Hands and feet are cold to the touch |
|
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| D002659 | Child Development Disorders, Pervasive |
| D010880 |
| Piperidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |