Down SyndromePhase 4TEAM-DSNCT04219280
Evaluating Treatment of ADHD in Children With Down Syndrome
A Phase 4 study testing Quillivant XR in people with Down Syndrome and ADHD, run by Children's Hospital Medical Center, Cincinnati at 4 sites in United States.
Trial summary
Children with Down syndrome (DS) have a 3-5 time greater prevalence of Attention Deficit Hyperactivity Disorder (ADHD) than typically developing (TD) children. Despite this higher risk of ADHD, rates of stimulant medication treatment are disproportionately low in children with DS+ADHD, even though stimulants are the… Read more about this study
- Who is it for?
- Ages 6 to 17 yearsHealthy volunteers can take part
- Conditions the study is for
- Down Syndrome, ADHD
- What is being tested?
- Quillivant XR
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 44 participants
- Where
- 4 sitesUnited States
- Study dates
- 2 Oct 2020to 31 Aug 2026
- Phase
- Phase 4
- Are there results?
- None posted in the registry
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 6 to 17 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Stated willingness to comply with all study procedures and availability for the duration of the study.
- Male or female, between the ages of 6.00-17.99 years at the time of consent.
- Able to take oral (liquid) medication.
- English is primary language.
- Meets criteria for ADHD (hyperactivity, inattention, or combined) on the KSADS
- Meets criteria for ADHD (hyperactivity, inattention, or combined) on the Vanderbilt (historically or currently, as indicated by a teacher/professional)
Who cannot join
- Current use of ADHD stimulant or non-stimulant medication and unwilling to discontinue for >/= 3 days prior to starting the study.
- Children with psychoses or bipolar disorder based on diagnostic interview with the parent.
- Organic Brain Injury: Children must not have a history of head trauma with loss of consciousness, epilepsy, or any other organic disorder that could possibly affect brain function.
- Specific heart conditions including the following:
- QTc on baseline ECG>470ms or QTC > 500 in patients with repaired CHD, as determined by ECG
- Brugada pattern, as determined by ECG
Show all 31Show fewer
- Baseline heart rate or systolic blood pressure > 2 SD above mean for age as determined by medical examination.
- 2nd or 3rd degree AV block, as determined by ECG
- History of aborted sudden cardiac death or unexplained syncope as determined by medical history
- History of a single ventricle as determined by medical history
- Valvular regurgitation or stenosis > mild, as determined by ECHO
- Moderate or greater ventricular dysfunction, as determined by ECHO
- Pulmonary hypertension, defined as right ventricular pressure >33% systemic pressure or septal position consistent with >mild right ventricular hypertension, as determined by ECHO
- Use of a pacemaker as determined by medical history
- Wolff Parkinson White/pre-ventricular excitation, as determined by ECG
- Atrial, junctional, or ventricular tachyarrhythmia, as determined by ECG
- Frequent premature ventricular contractions (PVCs) or premature atrial contractions (PACs), as determined by ECG
- Abnormal T waves with inversion in V5 and/or V6, bizarre T wave morphology, notched biphasic T waves, or ST segment depression suggesting ischemia or inflammation, as determined by ECG
- Moderate or larger atrial septal defect, as determined by ECHO
- Ventricular septal defect > small by ECHO
- Valvar stenosis > mild by ECHO
- Aortic root dilation > 2SD above mean by ECHO.
- If participants meet any of the following heart conditions, they must be evaluated for the study by a cardiologist before beginning:
- Right ventricular enlargement/right axis deviation, as determined by ECG
- Intraventricular conduction delay >120ms in child >12 years old or >100ms in child <8 years old, as determined by ECG
- Right or left bundle branch block, as determined by ECG
- Treatment with a monoamine oxidase inhibitor (MAOI) or use of an MAOI within 14 days.
- Active titration of non-ADHD, non-MAO psychotropic medication. Stable use of non-ADHD, non-MAO psychotropic medication, defined by no dose changes for >/= 4 weeks before starting the study medication trial, will be allowed.
- Known hypersensitivity or allergic reactions to methylphenidate or product components such as banana (due to bananas serving as flavoring in the formulation of the project's study interventions - Quillivant XR and the placebo).
- Severe Obstructive Sleep Apnea (OSA) as rated by McGill index of 4
- Pregnancy. (Since there is limited information regarding the safety of Quillivant XR during pregnancy, a pregnancy test will be conducted at the medical screen for female participants who have commenced the menstrual cycle. If pregnancy is indicated, the participant will be excluded from the study as a precautionary measure).
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Boston Children's Hospital
Boston, Massachusetts, 02115
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15203
University of California Davis MIND Institute
Sacramento, California, 95817
About this study
Official title: Evaluating Assessment and Medication Treatment of ADHD in Children With Down Syndrome
Children with Down syndrome (DS) have a 3-5 time greater prevalence of Attention Deficit Hyperactivity Disorder (ADHD) than typically developing (TD) children. Despite this higher risk of ADHD, rates of stimulant medication treatment are disproportionately low in children with DS+ADHD, even though stimulants are the most efficacious ADHD treatment and are recommended by consensus guidelines for use in children with intellectual disability and ADHD.
The investigators propose the first randomized clinical trial (RCT) of stimulant medication in children with DS+ADHD. This RCT may provide evidence regarding the short- and long-term safety and efficacy of stimulant use in children with DS+ADHD, both with and without CHD. All children enrolled in the study will complete a comprehensive assessment battery evaluating ADHD diagnostic criteria, as well as behavioral, cognitive, academic, and functional impairments.
Read the detailed description
The purpose of this study is to conduct a clinical trial of stimulant medication treatment (i.e., methylphenidate (MPH)) in children with DS+ADHD to determine methylphenidate's efficacy in remediating behavioral, cognitive, and functional impairments in children with DS+ADHD and to assess the short- and long-term safety of stimulant treatment in children with DS+ADHD with a specific focus on cardiac safety. It has the potential to significantly improve the outcomes of approximately 45,000 children with DS+ADHD nationwide.
To achieve this, 100 children with DS+ADHD, between the ages of 6.00-17.99 years, will be invited to participate in a clinical trial across four sites. Following pre-screening to determine study eligibility, children with DS+ADHD will be assessed at 13 different times points. The first pre-medication visit will include baseline intelligence, diagnostic, behavioral, cognitive, health, and functioning assessments. The second through sixth visits will begin Phase 1 of the clinical trial, and during this time, participants will begin the lowest dose of MPH and titrate incrementally upward per pediatric guidelines based on the participant's weight. Bieekly diagnostic and health assessments will be conducted to monitor the safety and efficacy of MPH during this phase. Further, this biweekly monitoring will ultimately guide the selection of the participant's optimal dose. At the seventh visit, participants will enter Phase 2 of the clinical trial where they will be randomized to receive an optimal dose of MPH (as determined by the assessments conducted throughout the titration phase) or the placebo. This visit will involve a repeat of most of the baseline measures. The eighth visit will initiate Phase 3 of the clinical trial in which participants will crossover to the study intervention not previously assigned during Phase 2. For example, a participant who was assigned his or her optimal dose during Phase 2 will receive the placebo during Phase 3, and vice versa. Further, this visit will involve a repeat of the assessments conducted during Phase 2 which allows each participants to serve as his or her own control, contributing data both while on an optimal dose of MPH and while on the placebo.
Prior to commencing Phase 4, MPH non-responders or placebo responders will be removed from the study and referred for non-study (clinical) treatment. Participants for whom MPH is judged to be effective and tolerable based on clinician ratings and parent/teacher reports will be invited to undergo an open label trial with their optimal MPH dose for a four-month maintenance period. During this phase, participants will undergo monthly diagnostic and health assessments to monitor the safety and efficacy of his or her optimal dose of MPH. The final visit (week 30) will include diagnostic, behavioral, cognitive, functioning, and health assessments to evaluate change across time.
- Conditions
- Down Syndrome, ADHD
- Being tested
- Quillivant XR, Placebo
- Medical subject headings
- Down Syndrome, Attention Deficit Disorder with Hyperactivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Quillivant XRDrug
Long-lasting liquid solution of Quillivant XR.
PlaceboDrug
Liquid solution to mimic the color and taste of Quillivant XR.
| Study group | Role | What they receive |
|---|---|---|
| Quillivant XR | Active comparator | Once-daily, long-lasting MPH solution with the following dosing schedules: 7.5mg/15mg/22.5mg/30mg for children 20-25kg 10mg/20mg/30mg/40mg for children 26-30kg 10mg/22mg/34mg/46mg for children > 30 mg Receives: Drug: Quillivant XR |
| Placebo | Placebo comparator | Liquid-based suspension to match the color and banana-flavor of Quillivant XR. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean magnitude of change in ADHD Symptoms as measured by parent and teacher report on the Vanderbilt ADHD Parent and Teacher Rating Scales, compared to placebo, during the optimal MPH dosage period. [ Time Frame: Phase 2, Phase 3 ]
A 49-item parent-report measure used to assess parent and teacher perceptions of youth's school and social functioning. The first 47 items assess symptoms of inattention, hyperactivity, combined inattention and hyperactivity, oppositional-defiant disorder, conduct disorder, and anxiety/depression. These items are scored on a 0-3 scale (0 = Never; 1 = Occasionally; 2 = Often; 3 = Very Often). The next two items measure impairment in performance and are scored on a 1-5 scale (1 = Above Average; 3 = Average; 5 = Problematic). For both sub-scales, lower scores mean better outcomes. Data will be entered into SPSS and used as a diagnostic outcome measure.
Measured: Baseline, Weeks 2-14, Weeks 18, 22, 26, and 30
Mean magnitude of change in Emotion Regulation as measured by parent and teacher report on the BRIEF2, compared to placebo, during the optimal MPH dosage period. [ Time Frame: Phase 2, Phase 3 ]
A 63-item parent and teacher rating scale used to assess everyday skills measuring executive functioning, including inhibition, shifting attention, emotional control, initiating tasks, problem solving, working memory, and monitoring activities. All 63-items are scored on a 3-item scale (N = never, S = Sometimes, O = Often). Scoring is performed through a software which generates T-scores for 13 sub-scales, with borderline and clinical ranges identified. Lower scores on this measure indicate better outcomes. Data will be entered into SPSS and used as a behavioral outcome measure.
Measured: Baseline, Week 12, Week 14, and Week 30
Secondary outcomes (9)
Mean magnitude change in Externalizing Behaviors as measured by parent and teacher report on the Achenbach Child Behavior Checklist (CBCL/TRF), compared to placebo, during the optimal MPH dosage period. [ Time Frame: Phase 2, Phase 3 ]
A 113-item rating scale used to obtain parent and teacher ratings of problem behaviors, in addition to descriptions of a child's strengths and challenges. All items are scored on a 0-2 scale (0 = Not True; 1 = Somewhat True or Sometimes True; 2 = Very True or Often True). T-scores for 8 sub-scales with borderline and clinical ranges are generated and identified through a scoring software, and lower scores on this measure indicate better outcomes. Data will be entered into SPSS and used as a behavioral outcome measure.
Measured: Baseline, Week 12, Week 14, and Week 30
Mean magnitude of change in Behavior Regulation as measured by parent and teacher report on the BRIEF2, compared to placebo, during the optimal MPH dosage period. [ Time Frame: Phase 2, Phase 3 ]
A 63-item parent and teacher rating scale used to assess everyday skills measuring executive functioning, including inhibition, shifting attention, emotional control, initiating tasks, problem solving, working memory, and monitoring activities. All 63-items are scored on a 3-item scale (N = never, S = Sometimes, O = Often). Scoring is performed through a software which generates T-scores for 13 sub-scales, with borderline and clinical ranges identified. Lower scores on this measure indicate better outcomes. Data will be entered into SPSS and used as a behavioral outcome measure.
Measured: Baseline, Week 12, Week 14, and Week 30
Frequency of clinically significant physician-collected cardiac occurrences on MPH - clinically significant change from baseline in ECG findings during the during the MPH titration trial [Phase 1] and the optimal MPH dosage maintenance period [Phase 4].
An ECG will be acquired at standard amplitude and speed (10mm/mV and 25mm/sec), and an electrophysiologist will inspect the recorded ECG for satisfactory quality and findings. The electrodes and lead wires will be applied to the extremities and chest with proper lead placement.The ECG readings will be used to assess the cardiovascular safety of stimulant medication treatment among the participants. Data will be reviewed by a cardiologist, and entered into SPSS to serve as a safety outcome measure.
Measured: Baseline, Week 8, Week 10, Week 22, and Week 30
Frequency of clinically significant cardiac occurrences on MPH- clinically significant changes for Heart Rate (HR) during the MPH titration trial [Phase 1] and the MPH dosage maintenance period [Phase 4].
HR will be assessed and collected by trained study staff and clinically significant changes will be tracked and assessed based on the participant's age.
Measured: Baseline, Weeks 2-14, Weeks 18, 22, 26, and 30
Frequency of clinically significant cardiac occurrences on MPH- clinically significant changes for Blood Pressure (BP) during the MPH titration trial [Phase 1] and the MPH dosage maintenance period [Phase 4].
BP measurement will be acquired by trained study staff or medical staff and clinically significant changes will be tracked and assessed based on the participant's age and height.
Measured: Baseline, Weeks 2-14, Weeks 18, 22, 26, and 30
Mean magnitude of change in Heart Rate (HR) compared to participants' pre-trial baseline, on maximum dosage of MPH received during the MPH titration trial [Phase 1] and during the optimal MPH dosage maintenance period [Phase 4].
HR will be acquired at each visit and compared to baseline measurements based on participant's age.
Measured: Baseline, Weeks 2-14, Weeks 18, 22, 26, and 30
Mean magnitude of change in Systolic Blood Pressure (SBP) compared to participants' pre-trial baseline, on maximum dosage of MPH received during the MPH titration trial [Phase 1] and during the optimal MPH dosage maintenance period [Phase 4].
SBP will be acquired at each visit and compared to baseline measurements based on participant's age and height.
Measured: Baseline, Weeks 2-14, Weeks 18, 22, 26, and 30
Mean magnitude of change in Diastolic Blood Pressure (DBP) compared to participants' pre-trial baseline, on maximum dosage of MPH received during the MPH titration trial [Phase 1] and during the optimal MPH dosage maintenance period [Phase 4].
DBP will be acquired at each visit and compared to baseline measurement based on participant's age and height.
Measured: Baseline, Weeks 2-14, Weeks 18, 22, 26, and 30
Frequency of parent-rated MPH side effects
A 19-item parent rating scale used to assess known side effects will be administered at each visit using a 4-item scale (0-None, 1-Mild, 2-Moderate, 3-Severe). A medical interview will be conducted to discuss side effects outside of the scope of this measurement and any unexpected or unrelated side effects or adverse events,
Measured: Baseline, Weeks 2-14, Weeks 18, 22, 26, and 30
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2020
- Study start2 Oct 2020
- Primary completion31 Aug 2026
- Study completion31 Aug 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Down SyndromeStudies of the same condition, open and under way.
- More trials run by Children's Hospital Medical Center, CincinnatiThe 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
- Factorial
- Model description
- Phase 1 is a Sequential model, Phase 2-3 is a Crossover model, Phase 4 is a Single-Group model.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Hospital Medical Center, Cincinnati
- Sponsor type
- University, hospital or other
- Collaborators
- University of California, Davis, University of Pittsburgh Medical Center, Boston Children's Hospital, Boston, MA, USA
- Responsible party
- Sponsor
- Investigators
- Anna Esbensen, PhD, Principal investigator, Children's Hospital Medical Center, CincinnatiTanya Froehlich, MD, Principal investigator, Children's Hospital Medical Center, CincinnatiKathleen Angkustsiri, MD, Principal investigator, University of California Davis MIND InstituteBenjamin Handen, MD, Principal investigator, University of Pittsburgh Medical CenterSabrina Sargado, MD, Principal investigator, Boston Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04219280
- Sponsor's protocol ID
- 2019-1016
- Acronym
- TEAM-DS
- Status last verified
- Oct 2026
- First submitted
- 31 Dec 2019
- Last updated
- 2 Nov 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: The research team will enter information in the clinical trial record at least once per year, and will enter the results of the primary outcomes within one year of the completion of the trial. The dataset generated and shared will include de-identified demographic information, parent- and teacher-rating scales, side effects and vital signs, cardiac monitoring, and blinded clinical global impressions. The dataset will include all composite variables and scores, with no identifying information included. The data and associated documentation will be made available to users only under a data sharing agreement.
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating Assessment and Medication Treatment of ADHD in Children With Down Syndrome
- ClinicalTrials.gov ID
- NCT04219280
- Acronym / sponsor ID
- TEAM-DS / 2019-1016
- Conditions
- Down Syndrome, ADHD
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Children's Hospital Medical Center, CincinnatiUniversity, hospital or other
- Collaborators
- University of California, Davis, University of Pittsburgh Medical Center, Boston Children's Hospital, Boston, MA, USA
- Study start
- 2 Oct 2020 (actual)
- Primary completion
- 31 Aug 2026 (actual)
- Study completion
- 31 Aug 2026 (actual)
- First posted
- 7 Jan 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Children with Down syndrome (DS) have a 3-5 time greater prevalence of Attention Deficit Hyperactivity Disorder (ADHD) than typically developing (TD) children. Despite this higher risk of ADHD, rates of stimulant medication treatment are disproportionately low in children with DS+ADHD, even though stimulants are the most efficacious ADHD treatment and are recommended by consensus guidelines for use in children with intellectual disability and ADHD.
The investigators propose the first randomized clinical trial (RCT) of stimulant medication in children with DS+ADHD. This RCT may provide evidence regarding the short- and long-term safety and efficacy of stimulant use in children with DS+ADHD, both with and without CHD. All children enrolled in the study will complete a comprehensive assessment battery evaluating ADHD diagnostic criteria, as well as behavioral, cognitive, academic, and functional impairments.
Detailed description
The purpose of this study is to conduct a clinical trial of stimulant medication treatment (i.e., methylphenidate (MPH)) in children with DS+ADHD to determine methylphenidate's efficacy in remediating behavioral, cognitive, and functional impairments in children with DS+ADHD and to assess the short- and long-term safety of stimulant treatment in children with DS+ADHD with a specific focus on cardiac safety. It has the potential to significantly improve the outcomes of approximately 45,000 children with DS+ADHD nationwide.
To achieve this, 100 children with DS+ADHD, between the ages of 6.00-17.99 years, will be invited to participate in a clinical trial across four sites. Following pre-screening to determine study eligibility, children with DS+ADHD will be assessed at 13 different times points. The first pre-medication visit will include baseline intelligence, diagnostic, behavioral, cognitive, health, and functioning assessments. The second through sixth visits will begin Phase 1 of the clinical trial, and during this time, participants will begin the lowest dose of MPH and titrate incrementally upward per pediatric guidelines based on the participant's weight. Bieekly diagnostic and health assessments will be conducted to monitor the safety and efficacy of MPH during this phase. Further, this biweekly monitoring will ultimately guide the selection of the participant's optimal dose. At the seventh visit, participants will enter Phase 2 of the clinical trial where they will be randomized to receive an optimal dose of MPH (as determined by the assessments conducted throughout the titration phase) or the placebo. This visit will involve a repeat of most of the baseline measures. The eighth visit will initiate Phase 3 of the clinical trial in which participants will crossover to the study intervention not previously assigned during Phase 2. For example, a participant who was assigned his or her optimal dose during Phase 2 will receive the placebo during Phase 3, and vice versa. Further, this visit will involve a repeat of the assessments conducted during Phase 2 which allows each participants to serve as his or her own control, contributing data both while on an optimal dose of MPH and while on the placebo.
Prior to commencing Phase 4, MPH non-responders or placebo responders will be removed from the study and referred for non-study (clinical) treatment. Participants for whom MPH is judged to be effective and tolerable based on clinician ratings and parent/teacher reports will be invited to undergo an open label trial with their optimal MPH dose for a four-month maintenance period. During this phase, participants will undergo monthly diagnostic and health assessments to monitor the safety and efficacy of his or her optimal dose of MPH. The final visit (week 30) will include diagnostic, behavioral, cognitive, functioning, and health assessments to evaluate change across time.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
- Model description
- Phase 1 is a Sequential model, Phase 2-3 is a Crossover model, Phase 4 is a Single-Group model.
| Arm | Type | Receives |
|---|---|---|
| Quillivant XR | Active comparator | Drug: Quillivant XROnce-daily, long-lasting MPH solution with the following dosing schedules: 7.5mg/15mg/22.5mg/30mg for children 20-25kg 10mg/20mg/30mg/40mg for children 26-30kg 10mg/22mg/34mg/46mg for children > 30 mg |
| Placebo | Placebo comparator | Drug: PlaceboLiquid-based suspension to match the color and banana-flavor of Quillivant XR. |
Who may qualify
- Ages
- 6 to 17 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- Stated willingness to comply with all study procedures and availability for the duration of the study.
- Male or female, between the ages of 6.00-17.99 years at the time of consent.
- Able to take oral (liquid) medication.
- English is primary language.
- Meets criteria for ADHD (hyperactivity, inattention, or combined) on the KSADS
Key exclusion criteria (31 listed)
- Current use of ADHD stimulant or non-stimulant medication and unwilling to discontinue for >/= 3 days prior to starting the study.
- Children with psychoses or bipolar disorder based on diagnostic interview with the parent.
- Organic Brain Injury: Children must not have a history of head trauma with loss of consciousness, epilepsy, or any other organic disorder that could possibly affect brain function.
- Specific heart conditions including the following:
- If participants meet any of the following heart conditions, they must be evaluated for the study by a cardiologist before beginning:
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 |
|---|---|---|
| Quillivant XRLong-lasting liquid solution of Quillivant XR. | Drug | Quillivant XR |
| PlaceboLiquid solution to mimic the color and taste of Quillivant XR. | Drug | Placebo |
Primary outcome
Mean magnitude of change in ADHD Symptoms as measured by parent and teacher report on the Vanderbilt ADHD Parent and Teacher Rating Scales, compared to placebo, during the optimal MPH dosage period. [ Time Frame: Phase 2, Phase 3 ]
Time frame: Baseline, Weeks 2-14, Weeks 18, 22, 26, and 30
A 49-item parent-report measure used to assess parent and teacher perceptions of youth's school and social functioning. The first 47 items assess symptoms of inattention, hyperactivity, combined inattention and hyperactivity, oppositional-defiant disorder, conduct disorder, and anxiety/depression. These items are scored on a 0-3 scale (0 = Never; 1 = Occasionally; 2 = Often; 3 = Very Often). The next two items measure impairment in performance and are scored on a 1-5 scale (1 = Above Average; 3 = Average; 5 = Problematic). For both sub-scales, lower scores mean better outcomes. Data will be entered into SPSS and used as a diagnostic outcome measure.
Mean magnitude of change in Emotion Regulation as measured by parent and teacher report on the BRIEF2, compared to placebo, during the optimal MPH dosage period. [ Time Frame: Phase 2, Phase 3 ]
Time frame: Baseline, Week 12, Week 14, and Week 30
A 63-item parent and teacher rating scale used to assess everyday skills measuring executive functioning, including inhibition, shifting attention, emotional control, initiating tasks, problem solving, working memory, and monitoring activities. All 63-items are scored on a 3-item scale (N = never, S = Sometimes, O = Often). Scoring is performed through a software which generates T-scores for 13 sub-scales, with borderline and clinical ranges identified. Lower scores on this measure indicate better outcomes. Data will be entered into SPSS and used as a behavioral outcome measure.
9 secondary outcomes
Mean magnitude change in Externalizing Behaviors as measured by parent and teacher report on the Achenbach Child Behavior Checklist (CBCL/TRF), compared to placebo, during the optimal MPH dosage period. [ Time Frame: Phase 2, Phase 3 ]
Time frame: Baseline, Week 12, Week 14, and Week 30
Mean magnitude of change in Behavior Regulation as measured by parent and teacher report on the BRIEF2, compared to placebo, during the optimal MPH dosage period. [ Time Frame: Phase 2, Phase 3 ]
Time frame: Baseline, Week 12, Week 14, and Week 30
Frequency of clinically significant physician-collected cardiac occurrences on MPH - clinically significant change from baseline in ECG findings during the during the MPH titration trial [Phase 1] and the optimal MPH dosage maintenance period [Phase 4].
Time frame: Baseline, Week 8, Week 10, Week 22, and Week 30
Frequency of clinically significant cardiac occurrences on MPH- clinically significant changes for Heart Rate (HR) during the MPH titration trial [Phase 1] and the MPH dosage maintenance period [Phase 4].
Time frame: Baseline, Weeks 2-14, Weeks 18, 22, 26, and 30
Frequency of clinically significant cardiac occurrences on MPH- clinically significant changes for Blood Pressure (BP) during the MPH titration trial [Phase 1] and the MPH dosage maintenance period [Phase 4].
Time frame: Baseline, Weeks 2-14, Weeks 18, 22, 26, and 30
Mean magnitude of change in Heart Rate (HR) compared to participants' pre-trial baseline, on maximum dosage of MPH received during the MPH titration trial [Phase 1] and during the optimal MPH dosage maintenance period [Phase 4].
Time frame: Baseline, Weeks 2-14, Weeks 18, 22, 26, and 30
Mean magnitude of change in Systolic Blood Pressure (SBP) compared to participants' pre-trial baseline, on maximum dosage of MPH received during the MPH titration trial [Phase 1] and during the optimal MPH dosage maintenance period [Phase 4].
Time frame: Baseline, Weeks 2-14, Weeks 18, 22, 26, and 30
Mean magnitude of change in Diastolic Blood Pressure (DBP) compared to participants' pre-trial baseline, on maximum dosage of MPH received during the MPH titration trial [Phase 1] and during the optimal MPH dosage maintenance period [Phase 4].
Time frame: Baseline, Weeks 2-14, Weeks 18, 22, 26, and 30
Frequency of parent-rated MPH side effects
Time frame: Baseline, Weeks 2-14, Weeks 18, 22, 26, and 30
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2026.
- Individual participant dataSharing planned: Yes. The research team will enter information in the clinical trial record at least once per year, and will enter the results of the primary outcomes within one year of the completion of the trial. The dataset generated and shared will include de-identified demographic information, parent- and teacher-rating scales, side effects and vital signs, cardiac monitoring, and blinded clinical global impressions. The dataset will include all composite variables and scores, with no identifying information included. The data and associated documentation will be made available to users only under a data sharing agreement.
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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.
Anna Esbensen, PhD principal investigator
Children's Hospital Medical Center, Cincinnati
Tanya Froehlich, MD principal investigator
Children's Hospital Medical Center, Cincinnati
Kathleen Angkustsiri, MD principal investigator
University of California Davis MIND Institute
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Quillivant XR in people with Down Syndrome and ADHD, run by Children's Hospital Medical Center, Cincinnati at 4 sites 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 31 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 2 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites 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. Some participants in this study may receive a placebo. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Mean magnitude of change in ADHD Symptoms as measured by parent and teacher report on the Vanderbilt ADHD Parent and Teacher Rating Scales, compared to placebo, during the optimal MPH dosage period. [ Time Frame: Phase 2, Phase 3 ] (time frame: Baseline, Weeks 2-14, Weeks 18, 22, 26, and 30). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 2 Nov 2026.