Using gabapentin to improve social cognition in adolescents with autism
Biomarker-Driven Pharmacological Treatment for Autism Spectrum Disorder
This study is testing if the medication gabapentin can help improve social skills in teenagers with autism by looking at changes in their brain chemistry over eight weeks.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 13 Years to 17 Years |
| Sex | All |
| Sponsor | University of Massachusetts, Worcester Academic / other |
| Locations | 1 site (Worcester, Massachusetts) |
| Trial ID | NCT05063656 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effects of gabapentin on social cognitive deficits in adolescents aged 13-17 with Autism Spectrum Disorder (ASD). By employing magnetic resonance spectroscopy (MRS) to measure GABA levels in the brain, the study aims to correct neurotransmitter imbalances that contribute to social cognition challenges. Participants will undergo an 8-week open-label treatment with gabapentin, with assessments including clinical measures of social cognition and neuroimaging to evaluate treatment response. The goal is to develop targeted therapies for ASD based on measurable brain biomarkers.
Who should consider this trial
Good fit: Ideal candidates are adolescents aged 13-17 diagnosed with Autism Spectrum Disorder and with an IQ above 70.
Not a fit: Patients with neurological or genetic disorders, unstable psychiatric conditions, or contraindications for MRI will not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly enhance social cognitive abilities in adolescents with autism, improving their quality of life.
How similar studies have performed: While the approach of using gabapentin in this context is novel, previous studies have shown promise in addressing neurotransmitter imbalances in ASD.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age 13-17 years * English as primary language (both child and legal guardian) * DSM-5 criteria for Autism Spectrum Disorder * IQ \>70 per Weschler Abbreviated Scale of Intelligence (WASI) * Informed assent for the study (The guardian must also give written informed consent) * For sexually active females, agreement to use two forms of contraception during trial to avoid pregnancy Exclusion Criteria: * Any neurological disorder (e.g., cerebral palsy, fetal alcohol syndrome, cerebral neoplasm, bacterial meningitis, epilepsy, etc.) * Genetic disorders (e.g., Fragile X, Rett Syndrome, etc.) * Contraindications for MRI, such as metallic or electronic implants in the body, or severe claustrophobia * Unstable psychiatric disorder expected to require psychotropic medication changes over the course of the study * History of psychotic disorder * Any condition that would prevent the subject from being able to complete study protocol * Unstable medical illness such as diabetes, asthma, thyroid disease * Currently on medications that cause respiratory depression, e.g. opioids, benzodiazepines * Clinically significant suicidal ideation as assessed by the Columbia Suicide Severity Rating Scale * History of intolerance to gabapentin or pregabalin * Current substance use (including nicotine) * Current treatment with gabapentin * History of renal dysfunction * Pregnancy in female participants.
Where this trial is running
Worcester, Massachusetts
- University of Massachusetts Medical School — Worcester, Massachusetts, United States (Recruiting)
Study contacts
- Principal investigator: David Cochran, MD — UMass Medical School
- Study coordinator: Taylor Merk
- Email: taylor.merk@umassmed.edu
- Phone: 774-455-4112
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.