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
Overview
- Phase
- Phase 4
- Intervention
- Methylphenidate extended-release liquid formulation
- Conditions
- Attention-deficit/Hyperactivity Disorder
- Sponsor
- Massachusetts General Hospital
- Enrollment
- 15
- Locations
- 1
- Primary Endpoint
- Change in Adult ADHD Investigator Symptom Report Scale (AISRS) Score
- Status
- Completed
- Last Updated
- last year
Overview
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).
Investigators
Gagan Joshi
Assistant professor of Psychiatry, Harvard Medical School; Director, Autism Spectrum Disorder Clinical & Research Program, Pediatric Psychopharmacology
Massachusetts General Hospital
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
Methylphenidate extended-release liquid
Methylphenidate extended-release liquid formulation
Intervention: Methylphenidate extended-release liquid formulation
Outcomes
Primary Outcomes
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.