ADHDPhase 4NCT02255565
Dose Response Effects of Quillivant XR in Children With ADHD and Autism: A Pilot Study
A Phase 4 study testing Very Low Dose Quillivant XR, Low Dose Quillivant XR and Moderate Dose Quillivant XR in people with ADHD and Autism, run by Seattle Children's Hospital at 1 site in United States.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 5 to 16 years
- What is being tested?
- Very Low Dose Quillivant XR, Low Dose Quillivant XR and Moderate Dose Quillivant XR
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2014to Oct 2016
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 16 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- A clinical diagnosis of Autistic disorder or Asperger's disorder by DSM-IV or Autism Spectrum Disorder by DSM-V.
- A DSM-V diagnosis of ADHD based upon the K-SADS-P.
- Clinical Global Impressions - Severity for ADHD (CGI-S-ADHD) rating > 4.
- Findings on physical exam, labs and ECG are judged to be normal for age with pulse and blood pressure within 95% of age and gender mean.
- Informed consent by a parent or legal guardian, and assent for children with developmental age 7 years or older.
- At least one parent fluent in English
Who cannot join
- History of Seizure disorder (Febrile seizures are non-exclusionary).
- History of Intellectual Disability (IQ< 70)
- Treatment with MAO Inhibitor (or within 14 days following discontinuation of MAO Inhibitor).
- Other psychotropic medication other than stable dose of Selective Serotonin Reuptake Inhibitors, which is permitted)
- Known to be hypersensitive to methylphenidate, or other components of Quillivant XR
- Cardiac or other medical contraindications for stimulant trial (e.g., family history of heart attack at age younger than 40 years, personal history of heart disease, history of fainting while exercising, structural cardiac abnormalities, cardiomyopathy, serious cardiac arrhythmias, coronary artery disease, or other serious cardiac problems. If any doubt, children will be referred to a cardiologist for a cardiac clearance.
- Raynaud's disease
- Pregnancy or Breast-feeding.
Trial locations and contacts
1 site in 1 country.
United States1 site
Seattle Children's Hospital
Seattle, Washington, 98105
About this study
Official title: Quillivant XR in Children With Attention Deficit/Hyperactivity Disorder (ADHD) and Autism Spectrum Disorder (ASD): A Pilot Study
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).
Read the detailed description
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.
- Being tested
- Very Low Dose Quillivant XR, Low Dose Quillivant XR, Moderate Dose Quillivant XR
- Keywords
- Quillivant
- Medical subject headings
- Attention Deficit Disorder with Hyperactivity, Autistic Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Very Low Dose Quillivant XRDrug
Also called Methylphenidate HCl
Oral suspension dose once a day increasing to a 10mg dose
Low Dose Quillivant XRDrug
Also called Methylphenidate HCl
Oral suspension dose once a day increasing to a 20mg dose
Moderate Dose Quillivant XRDrug
Also called Methylphenidate HCl
Oral suspension dose once a day increasing to a 40mg dose
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Very Low Dose Quillivant XR |
| 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. Receives: Drug: Low Dose Quillivant XR |
| 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. Receives: Drug: Moderate Dose Quillivant XR |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: once a week for 6 weeks
Secondary outcomes (2)
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.
Measured: once a week for 6 weeks
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.
Measured: once a week for 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2014 (estimated)
- Study startSep 2014
- Primary completionSep 2016
- Study completionOct 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for ADHDStudies of the same condition, open and under way.
- More trials run by Seattle Children's HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seattle Children's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Pfizer
- Responsible party
- Principal investigator, Mark Stein, Seattle Children's Hospital
- Investigators
- Mark Stein, PhD, Principal investigator, Seattle Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02255565
- Sponsor's protocol ID
- WI185890
- Status last verified
- Jul 2017
- First submitted
- 24 Sep 2014
- Last updated
- 1 Aug 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
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.
PubMed 16477513Lee 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.
PubMed 17201617Rao, P. A. and R. J. Landa (2013).
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.
PubMed 16275814Stein, M.A. et al.
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Quillivant XR in Children With Attention Deficit/Hyperactivity Disorder (ADHD) and Autism Spectrum Disorder (ASD): A Pilot Study
- ClinicalTrials.gov ID
- NCT02255565
- Acronym / sponsor ID
- WI185890
- Keywords
- Quillivant
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Seattle Children's HospitalUniversity, hospital or other
- Collaborators
- Pfizer
- Study start
- Sep 2014
- Primary completion
- Sep 2016 (actual)
- Study completion
- Oct 2016 (actual)
- First posted
- 2 Oct 2014 (estimated)
- Results
- Posted 5 Jun 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Very Low Dose Quillivant XR | Experimental | Drug: Very Low Dose Quillivant XRPatients 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 | Drug: Low Dose Quillivant XRPatients 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 | Drug: Moderate Dose Quillivant XRPatients in this treatment arm are given Quillivant XR (a liquid medication) to treat ADHD at a moderate dose level for 6 weeks. |
Who may qualify
- Ages
- 5 to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- A clinical diagnosis of Autistic disorder or Asperger's disorder by DSM-IV or Autism Spectrum Disorder by DSM-V.
- A DSM-V diagnosis of ADHD based upon the K-SADS-P.
- Clinical Global Impressions - Severity for ADHD (CGI-S-ADHD) rating > 4.
- Findings on physical exam, labs and ECG are judged to be normal for age with pulse and blood pressure within 95% of age and gender mean.
- Informed consent by a parent or legal guardian, and assent for children with developmental age 7 years or older.
Key exclusion criteria (8 listed)
- History of Seizure disorder (Febrile seizures are non-exclusionary).
- History of Intellectual Disability (IQ< 70)
- Treatment with MAO Inhibitor (or within 14 days following discontinuation of MAO Inhibitor).
- Other psychotropic medication other than stable dose of Selective Serotonin Reuptake Inhibitors, which is permitted)
- Known to be hypersensitive to methylphenidate, or other components of Quillivant XR
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Very Low Dose Quillivant XRAlso: Methylphenidate HClOral suspension dose once a day increasing to a 10mg dose | Drug | Very Low Dose Quillivant XR |
| Low Dose Quillivant XRAlso: Methylphenidate HClOral suspension dose once a day increasing to a 20mg dose | Drug | Low Dose Quillivant XR |
| Moderate Dose Quillivant XRAlso: Methylphenidate HClOral suspension dose once a day increasing to a 40mg dose | Drug | Moderate dose Quillivant XR |
Primary outcome
ADHD Rating Scale - IV
Time frame: once a week for 6 weeks
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.
2 secondary outcomes
Clinical Global Impressions-ADHD - Severity
Time frame: once a week for 6 weeks
Clinical Global Impression - Improvement (CGI-I)
Time frame: once a week for 6 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 16477513Gadow 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.
- Background: PubMed 17201617Lee 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.
- BackgroundRao, P. A. and R. J. Landa (2013).
- Background: PubMed 16275814Research 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.
- BackgroundStein, M.A. et al.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mark Stein, PhD principal investigator
Seattle Children's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Very Low Dose Quillivant XR, Low Dose Quillivant XR and Moderate Dose Quillivant XR in people with ADHD and Autism, run by Seattle Children's Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 5 Jun 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ADHD Rating Scale - IV (time frame: once a week for 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02255565, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Aug 2017.