Attention-deficit/Hyperactivity DisorderPhase 4NCT02096952
Methylphenidate ER Liquid Formulation in Adults With ASD and ADHD
A Phase 4 study testing Methylphenidate extended-release liquid formulation in people with Attention-deficit/Hyperactivity Disorder and Autism Spectrum Disorder, run by Massachusetts General Hospital at 1 site in United States.
Trial summary
The purpose of this study is to determine whether methylphenidate hydrochloride extended release liquid formulation is safe and effective in the treatment of attention-deficit/hyperactivity disorder (ADHD) in high-functioning adults with autism spectrum disorders (ASD). Read more about this study
- Who is it for?
- Ages 18 to 40 years
- Conditions the study is for
- Attention-deficit/Hyperactivity Disorder, Autism Spectrum Disorder
- What is being tested?
- Methylphenidate extended-release liquid formulation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- May 2014to Jan 2018
- 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 18 to 40 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Male or female participants between 18 and 40 years of age (inclusive)
- Fulfills DSM-5 diagnostic criteria for autism spectrum disorder as established by the clinical diagnostic interview and ADOS
- Fulfills DSM-5 diagnostic criteria for ADHD as established by the clinical diagnostic interview and confirmed by the K-SADS-E ADHD module
- Participants with at least moderately severe symptoms of ASD as demonstrated by SRS raw score ≥ 85 and CGI-ASD severity score ≥ 4
- Participants with at least moderately severe symptoms of ADHD as assessed by AISRS score ≥ 24 and CGI-ADHD severity score ≥ 4
- Participants and/or their legal representative must understand the nature of the study. Participants and/or their legal representative must sign an IRB-approved informed consent form before initiation of any study procedures.
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- Participants and/or their legal representative must have a level of understanding sufficient to communicate with the investigator and study coordinator, and to cooperate with all tests and examinations required by the protocol.
- Participant must be able to participate in mandatory blood draws.
- Participant with major mood and/or anxiety disorders will be allowed to participate in the study provided they do not meet any exclusionary criteria.
Who cannot join
- Impaired intellectual capacity (IQ <85)
- Participant is unable to communicate due to delay in, or total lack of, spoken language development (grossly impaired language skills)
- Clinically unstable psychiatric conditions or judged to be at serious safety risk to self (suicidal risk) or others (within past 30 days).
- Subjects currently (within past 30 days) experiencing significant features of anxiety, mood, or psychotic disorder as indicated by a >3 score on the disorder-specific Clinical Global Impression-Severity (CGI-S) clinician-rated scale.
- History of substance use (except nicotine or caffeine) within past 3 months (inclusive) or with urine drug screen positive for substances of abuse
- Subjects with a medical condition or treatment that will either jeopardize subject safety or affect the scientific merit of the study, including:
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- Pregnant or nursing females or females with a positive beta-HCG pregnancy test.
- Uncorrected hypothyroidism or hyperthyroidism.
- History of non-febrile seizures within last 1 month without a clear and resolved etiology.
- History of renal or hepatic impairment.
- Glaucoma
- Tourette's syndrome and/or motor tics
- Serious, unstable systemic illness
- Personal history of cardiac disease or a family history of non-geriatric cardiac disease or death
- Clinically significant abnormal baseline laboratory values which include the following:
- Values more than 20% above the upper range of the laboratory standard for a basic metabolic screen.
- Systolic and diastolic blood pressure parameters above 140 and 90, respectively.
- Resting heart rate outside of 60-100 bpm.
- Abnormal ECG parameters defined as QTC> 460msec, QRS>120 msec, and/or PR>200 msec.
- ECG evidence of ischemia or arrhythmia as reviewed by an independent cardiologist.
- Participant with a history of non-response to adequate trial of methylphenidate (therapeutic dose for an adequate duration) as determined by clinician.
- History of intolerance or an allergic reaction to methylphenidate.
- Current or recent treatment (within the past 30 days) with current stimulant class of anti-ADHD medications.
- Current treatment with monoamine oxidase inhibitors (MAOIs)
- Current treatment with a first- or second-generation antipsychotic medication on a dose that has not been stable for at least 4 weeks prior to baseline visit.
- Current treatment with a psychotropic medication on a dose that has not been stable for at least 4 weeks prior to baseline visit.
- Investigator and his/her immediate family, defined as the investigator's spouse, parent, child, grandparent, or grandchild.
- While stably treated or remitted hypertension is not exclusionary, any subject with a history of high blood pressure will be asked to obtain approval from their primary care physician certifying that their hypertension is stable and that they may safely begin stimulant therapy. Subjects will be informed of the cardiovascular risks of MPH, and any subject with a history of hypertension who is unwilling to consult with their current treater-or to grant study staff permission to consult with the subject's current treater-will be excluded because of the potential risks to subject safety. Per the FDA approved MPH-ERLF package insert, high blood pressure is not a contraindication of MPH therapy; however, due to the cardiovascular side effects, it is recommended that subjects with a history of high blood pressure be monitored carefully. Cardiovascular risk factors are carefully monitored throughout the study for all subjects by way of screening electrocardiograms and pulse/blood pressure readings at every office visit. Patients with current untreated hypertension are not eligible.
Trial locations and contacts
1 site in 1 country.
United States1 site
Massachusetts General Hospital
Boston, Massachusetts, 02144
About this study
Official title: Open-Label Treatment Trial to Assess the Short-Term Tolerability, Safety, and Efficacy of Methylphenidate Hydrochloride Extended-Release Liquid Formulation in High-Functioning Autism Spectrum Disorder Adults With Attention-Deficit/Hyperactivity Disorder
The purpose of this study is to determine whether methylphenidate hydrochloride extended release liquid formulation is safe and effective in the treatment of attention-deficit/hyperactivity disorder (ADHD) in high-functioning adults with autism spectrum disorders (ASD).
- Being tested
- Methylphenidate extended-release liquid formulation
- Keywords
- Attention-deficit/hyperactivity disorder, ADHD, Autism spectrum disorder, ASD, High-functioning ASD, Asperger's disorder, Asperger's
- Medical subject headings
- Attention Deficit Disorder with Hyperactivity, Autism Spectrum Disorder, Asperger Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Methylphenidate extended-release liquid formulationDrug
Also called Quillivant extended release
| Study group | Role | What they receive |
|---|---|---|
| Methylphenidate extended-release liquid | Experimental | Methylphenidate extended-release liquid formulation Receives: Drug: Methylphenidate extended-release liquid formulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Adult ADHD Investigator Symptom Report Scale (AISRS) Score
The Adult ADHD Investigator Symptom Report Scale (AISRS) assesses each of the 18 individual symptoms of ADHD in DSM-IV on a Likert scale from 0 (not present) to 3 (severe), with a total possible score of 54.
The change in AISRS score from baseline to endpoint (6 weeks) was calculated as the later time point score minus the earlier time point score.
Measured: Baseline to 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2014 (estimated)
- Study startMay 2014
- Primary completionJan 2018
- Study completionJan 2018
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 (1)Papers the sponsor has linked to this study.
- Other trials for Attention-deficit/Hyperactivity DisorderStudies of the same condition, open and under way.
- More trials run by Massachusetts General 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gagan Joshi, Massachusetts General Hospital
- Investigators
- Gagan Joshi, MD, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02096952
- Sponsor's protocol ID
- 2014P000501
- Status last verified
- Jun 2024
- First submitted
- 24 Mar 2014
- Last updated
- 1 Jul 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Joshi G, DiSalvo M, Wozniak J, Ceranoglu TA, Yule A, Surman C, Fried R, Galdo M, Hoskova B, Belser A, Biederman J. A prospective open-label trial of long-acting liquid methylphenidate for the treatment of attention deficit/hyperactivity disorder in intellectually capable adults with autism spectrum disorder. World J Biol Psychiatry. 2020 Apr;21(4):274-290. doi: 10.1080/15622975.2019.1679392. Epub 2019 Dec 19.
PubMed 31607204
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open-Label Treatment Trial to Assess the Short-Term Tolerability, Safety, and Efficacy of Methylphenidate Hydrochloride Extended-Release Liquid Formulation in High-Functioning Autism Spectrum Disorder Adults With Attention-Deficit/Hyperactivity Disorder
- ClinicalTrials.gov ID
- NCT02096952
- Acronym / sponsor ID
- 2014P000501
- Keywords
- Attention-deficit/hyperactivity disorder, ADHD, Autism spectrum disorder, ASD, High-functioning ASD, Asperger's disorder, Asperger's
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Study start
- May 2014
- Primary completion
- Jan 2018 (actual)
- Study completion
- Jan 2018 (actual)
- First posted
- 26 Mar 2014 (estimated)
- Results
- Posted 23 Feb 2018
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 methylphenidate hydrochloride extended release liquid formulation is safe and effective in the treatment of attention-deficit/hyperactivity disorder (ADHD) in high-functioning adults with autism spectrum disorders (ASD).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Methylphenidate extended-release liquid | Experimental | Drug: Methylphenidate extended-release liquid formulationMethylphenidate extended-release liquid formulation |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- Male or female participants between 18 and 40 years of age (inclusive)
- Fulfills DSM-5 diagnostic criteria for autism spectrum disorder as established by the clinical diagnostic interview and ADOS
- Fulfills DSM-5 diagnostic criteria for ADHD as established by the clinical diagnostic interview and confirmed by the K-SADS-E ADHD module
- Participants with at least moderately severe symptoms of ASD as demonstrated by SRS raw score ≥ 85 and CGI-ASD severity score ≥ 4
- Participants with at least moderately severe symptoms of ADHD as assessed by AISRS score ≥ 24 and CGI-ADHD severity score ≥ 4
Key exclusion criteria (28 listed)
- Impaired intellectual capacity (IQ <85)
- Participant is unable to communicate due to delay in, or total lack of, spoken language development (grossly impaired language skills)
- Clinically unstable psychiatric conditions or judged to be at serious safety risk to self (suicidal risk) or others (within past 30 days).
- Subjects currently (within past 30 days) experiencing significant features of anxiety, mood, or psychotic disorder as indicated by a >3 score on the disorder-specific Clinical Global Impression-Severity (CGI-S) clinician-rated scale.
- History of substance use (except nicotine or caffeine) within past 3 months (inclusive) or with urine drug screen positive for substances of abuse
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 |
|---|---|---|
| Methylphenidate extended-release liquid formulationAlso: Quillivant extended release | Drug | Methylphenidate extended-release liquid |
Primary outcome
Change in Adult ADHD Investigator Symptom Report Scale (AISRS) Score
Time frame: Baseline to 6 weeks
The Adult ADHD Investigator Symptom Report Scale (AISRS) assesses each of the 18 individual symptoms of ADHD in DSM-IV on a Likert scale from 0 (not present) to 3 (severe), with a total possible score of 54. The change in AISRS score from baseline to endpoint (6 weeks) was calculated as the later time point score minus the earlier time point score.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 31607204Joshi G, DiSalvo M, Wozniak J, Ceranoglu TA, Yule A, Surman C, Fried R, Galdo M, Hoskova B, Belser A, Biederman J. A prospective open-label trial of long-acting liquid methylphenidate for the treatment of attention deficit/hyperactivity disorder in intellectually capable adults with autism spectrum disorder. World J Biol Psychiatry. 2020 Apr;21(4):274-290. doi: 10.1080/15622975.2019.1679392. Epub 2019 Dec 19.
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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.
Gagan Joshi, MD principal investigator
Massachusetts General 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 Methylphenidate extended-release liquid formulation in people with Attention-deficit/Hyperactivity Disorder and Autism Spectrum Disorder, run by Massachusetts General 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 9 inclusion and 28 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 Jul 2024. 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 23 Feb 2018). 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?
Change in Adult ADHD Investigator Symptom Report Scale (AISRS) Score (time frame: Baseline to 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 NCT02096952, which also lists 1 linked publication.
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 Jul 2024.