Gabapentin for Autism
Trial Summary
What is the purpose of this trial?
This trial tests whether gabapentin can improve social skills in adolescents with autism by increasing levels of a calming brain chemical called GABA. The study involves 40 adolescents and aims to see if this treatment can correct brain chemical imbalances and improve social interactions.
Do I need to stop my current medications to join the trial?
The trial does not specify if you need to stop all current medications, but you cannot participate if you are on medications that cause respiratory depression, like opioids or benzodiazepines, or if you are currently being treated with gabapentin.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications, but you cannot participate if you are currently taking medications that cause respiratory depression or if you are already on gabapentin.
What data supports the idea that Gabapentin for Autism is an effective treatment?
The available research does not provide specific data supporting the effectiveness of Gabapentin for treating autism. Instead, it discusses other drugs like risperidone and haloperidol, which have shown some positive effects on symptoms associated with autism. However, these drugs can have significant side effects. Overall, there is no consensus or strong evidence from controlled studies validating the effectiveness of Gabapentin or other drugs specifically for autism.12345
What safety data exists for gabapentin treatment?
Gabapentin has been studied for safety in various contexts, primarily as an add-on therapy for partial seizures. Common adverse effects include somnolence, dizziness, and fatigue. In clinical trials, adverse events were reported in 69% of patients taking 900 mg/day and 64% taking 1,200 mg/day, compared to 52% in the placebo group. No significant hepatic or hematopoietic effects were observed. Additionally, there are reports of hypoglycemia as a potential adverse effect, particularly in patients with diabetes or on dialysis.678910
Is gabapentin generally safe for humans?
Is the drug Gabapentin promising for treating autism?
The research articles mainly discuss Gabapentin as a drug for epilepsy and pain management, not autism. They highlight its effectiveness in treating seizures and certain types of pain, but do not provide evidence or claims about its use for autism. Therefore, based on the available information, Gabapentin is not shown to be a promising treatment for autism.1112131415
How is the drug Gabapentin unique for treating autism?
Gabapentin is unique because it is primarily used as an anti-epileptic drug and for treating nerve pain, but its use in autism is novel as there are no standard treatments specifically for autism. It has a low incidence of side effects and minimal drug interactions, which may make it a promising option for managing symptoms in autism.1112131415
Research Team
David Cochran, MD
Principal Investigator
UMass Medical School
Eligibility Criteria
This trial is for English-speaking adolescents aged 13-17 with Autism Spectrum Disorder and an IQ over 70. They must be able to give informed assent, with a guardian's consent, and not have genetic disorders like Fragile X or Rett Syndrome. Participants should not have metal implants, severe claustrophobia, unstable psychiatric conditions requiring medication changes during the study, significant medical illnesses, renal dysfunction or be pregnant.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Acute Response Assessment
Single dose challenge of gabapentin to evaluate immediate GABA response
Treatment
8-week open-label treatment with gabapentin to assess sustained GABA response and clinical improvements
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- Gabapentin
Gabapentin is already approved in United States, European Union, Canada for the following indications:
- Postherpetic neuralgia
- Partial-onset seizures
- Peripheral neuropathic pain
- Partial-onset seizures
- Postherpetic neuralgia
- Partial-onset seizures
Find a Clinic Near You
Who Is Running the Clinical Trial?
David Cochran
Lead Sponsor
Eagles Autism Foundation
Collaborator