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Study of Neuroimaging Biomarkers of Social Cognition Deficits in Adolescents (Age 13-17) With Autism Spectrum Disorder and Effects of Gabapentin
Phase < 1
Waitlist Available
Led By David Cochran, MD, PhD
Research Sponsored by University of Massachusetts, Worcester
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 hours post-administration
Awards & highlights
No Placebo-Only Group
Summary
This trial tests gabapentin, a medication for nerve pain and seizures, to see if it can help adolescents with Autism Spectrum Disorder (ASD) improve their social communication skills. The study focuses on adolescents aged 13-17 because they often struggle with social communication. Gabapentin may work by increasing a calming brain chemical called GABA. Gabapentin is a newer medication used in children and has been evaluated for its effectiveness and safety in various studies.
Eligible Conditions
- Autism Spectrum Disorder
- Autism
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 6 hours post-administration
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 hours post-administration
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Cortical GABA in Anterior Cingulate Cortex
Cortical GABA in Right Anterior Insula
Secondary study objectives
Cortical Glx in Anterior Cingulate Cortex
Cortical Glx in Right Anterior Insula
Side effects data
From 2021 Phase 4 trial • 88 Patients • NCT030128152%
Allergic reaction
100%
80%
60%
40%
20%
0%
Study treatment Arm
Gabapentin
Benzodiazepine
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: GabapentinExperimental Treatment1 Intervention
Single dose of gabapentin 900 mg will be given and neuroimaging markers will be measured before and after administration of gabapentin
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Gabapentin
2013
Completed Phase 4
~1550
Find a Location
Who is running the clinical trial?
National Institute of Mental Health (NIMH)NIH
2,928 Previous Clinical Trials
2,745,000 Total Patients Enrolled
84 Trials studying Autism Spectrum Disorder
41,233 Patients Enrolled for Autism Spectrum Disorder
University of Massachusetts, WorcesterLead Sponsor
362 Previous Clinical Trials
993,027 Total Patients Enrolled
2 Trials studying Autism Spectrum Disorder
6,664 Patients Enrolled for Autism Spectrum Disorder
Johns Hopkins UniversityOTHER
2,332 Previous Clinical Trials
14,874,881 Total Patients Enrolled
6 Trials studying Autism Spectrum Disorder
239 Patients Enrolled for Autism Spectrum Disorder
David Cochran, MD, PhDPrincipal Investigator - University of Massachusetts, Worcester
UMass Memorial Medical Center-University Campus