Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 11:24 PM
Ignite Modification Date:
2025-12-24 @ 11:24 PM
NCT ID:
NCT05063656
Eligibility 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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
13 Years
Maximum Age:
17 Years
Study:
NCT05063656
Study Brief:
Protocol Section:
NCT05063656