Methylphenidate ER Liquid Formulation in Adults With ASD and ADHD

NCT02096952 | Completed Phase 4 Results

• 1 other identifier: 2014P000501
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Attention-deficit/Hyperactivity Disorder; Autism Spectrum Disorder

Keywords

Attention-deficit/hyperactivity disorder; ADHD; Autism spectrum disorder; ASD; High-functioning ASD; Asperger's disorder; Asperger's

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline to 6 weeks

Study Arms (1)

Methylphenidate extended-release liquid

EXPERIMENTAL

Methylphenidate extended-release liquid formulation

Drug: Methylphenidate extended-release liquid formulation

Interventions

Methylphenidate extended-release liquid formulation DRUG

Also known as: Quillivant extended release

Methylphenidate extended-release liquid

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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:

Sponsors & Collaborators

• Massachusetts General Hospital: lead

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02144, United States

Location

Related Publications (1)

• 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.

  PMID: 31607204 DERIVED

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity; Autism Spectrum Disorder; Asperger Syndrome

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Mental Disorders; Child Development Disorders, Pervasive

Results Point of Contact

• Title: Dr. Gahan Joshi
• Organization: Massachusetts General Hospital

joshi.gagan@mgh.harvard.edu

617-726-8392

Study Officials

• Gagan Joshi, MD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant professor of Psychiatry, Harvard Medical School; Director, Autism Spectrum Disorder Clinical & Research Program, Pediatric Psychopharmacology

Study Record Dates

• First Submitted: March 24, 2014
• First Posted: March 26, 2014
• Study Start: May 1, 2014
• Primary Completion: January 1, 2018
• Study Completion: January 1, 2018
• Last Updated: July 1, 2024
• Results First Posted: February 23, 2018

Record last verified: 2024-06

Locations

US (1)