Methylphenidate ER Liquid Formulation in Adults With ASD and ADHD (NCT02096952) | Clinical Trial Compass
CompletedPhase 4
Methylphenidate ER Liquid Formulation in Adults With ASD and ADHD
United States15 participantsStarted 2014-05
Plain-language 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).
Who can participate
Age range18 Years – 40 Years
SexALL
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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)
*…
What they're measuring
1
Change in Adult ADHD Investigator Symptom Report Scale (AISRS) Score