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Methylphenidate ER Liquid Formulation in Adults With ASD and ADHD

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2016 by Massachusetts General Hospital
Sponsor:
Information provided by (Responsible Party):
Gagan Joshi, MD, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT02096952
First received: March 24, 2014
Last updated: August 10, 2016
Last verified: August 2016
  Purpose
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).

Condition Intervention Phase
Attention-deficit/Hyperactivity Disorder
Autism Spectrum Disorder
Drug: Methylphenidate extended-release liquid formulation
Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Massachusetts General Hospital:

Primary Outcome Measures:
  • Adult ADHD Investigator Symptom Report Scale (AISRS) [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 40
Study Start Date: May 2014
Estimated Study Completion Date: November 2016
Estimated Primary Completion Date: November 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Methylphenidate extended-release liquid
Methylphenidate extended-release liquid formulation
Drug: Methylphenidate extended-release liquid formulation
Other Name: Quillivant extended release

  Eligibility

Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria

  • 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.
  • 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.

Exclusion Criteria

  • 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:
  • 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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02096952

Contacts
Contact: Ryan Kilcullen 617-724-7301 jrkilcullen@mgh.harvard.edu
Contact: Alexa Pulli, BS 617-726-4651 apulli@mgh.harvard.edu

Locations
United States, Massachusetts
Massachusetts General Hospital Recruiting
Boston, Massachusetts, United States, 02144
Contact: Ryan Kilcullen    617-724-7301    jrkilcullen@mgh.harvard.edu   
Contact: Leah Feinberg, BS    617-726-4651    lkfeinberg@mgh.harvard.edu   
Principal Investigator: Gagan Joshi, MD         
Sponsors and Collaborators
Massachusetts General Hospital
Investigators
Principal Investigator: Gagan Joshi, MD Massachusetts General Hospital
  More Information

Responsible Party: Gagan Joshi, MD, Assistant professor of Psychiatry, Harvard Medical School; Director, Autism Spectrum Disorder Clinical & Research Program, Pediatric Psychopharmacology, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT02096952     History of Changes
Other Study ID Numbers: 2014P000501 
Study First Received: March 24, 2014
Last Updated: August 10, 2016
Health Authority: United States: Food and Drug Administration

Keywords provided by Massachusetts General Hospital:
Attention-deficit/hyperactivity disorder
ADHD
Autism spectrum disorder
ASD
High-functioning ASD
Asperger's disorder
Asperger's

Additional relevant MeSH terms:
Disease
Attention Deficit Disorder with Hyperactivity
Autistic Disorder
Hyperkinesis
Autism Spectrum Disorder
Child Development Disorders, Pervasive
Pathologic Processes
Attention Deficit and Disruptive Behavior Disorders
Neurodevelopmental Disorders
Mental Disorders
Dyskinesias
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Methylphenidate
Central Nervous System Stimulants
Physiological Effects of Drugs
Dopamine Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Dopamine Agents
Neurotransmitter Agents

ClinicalTrials.gov processed this record on September 27, 2016