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Methylphenidate ER Liquid Formulation in Adults With ASD and ADHD

Phase 4
Completed
Conditions
Autism Spectrum Disorder
Attention-deficit/Hyperactivity Disorder
Interventions
Registration Number
NCT02096952
Lead Sponsor
Massachusetts General Hospital
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).

Detailed Description

Not available

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
15
Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

Study Type
INTERVENTIONAL
Study Design
SINGLE_GROUP
Arm && Interventions
GroupInterventionDescription
Methylphenidate extended-release liquidMethylphenidate extended-release liquid formulationMethylphenidate extended-release liquid formulation
Primary Outcome Measures
NameTimeMethod
Change in Adult ADHD Investigator Symptom Report Scale (AISRS) ScoreBaseline 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.

Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (1)

Massachusetts General Hospital

🇺🇸

Boston, Massachusetts, United States

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