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 @ 3:02 PM
Ignite Modification Date:
2025-12-24 @ 3:02 PM
NCT ID:
NCT01230359
Eligibility Criteria:
Inclusion Criteria:
* Children between 2-6 years of age referred to Pediatrics Rehabilitation Clinic with suspected ASD and pre-screened with DSM IV-R.
* Each patient will be free of psychoactive medication for at least 3 months prior to the entry into the trial.
Exclusion Criteria:
* \- Patients with chronic illness or known hormonal or metabolic disease.
* Patients with known genetic or chromosomal syndromes.
* Inability of parents to give informed consent, travel to the clinic visits, administer study medication or arrange for completion of rating scales.
We will not to exclude children on other concurrent medications (e.g. antibiotics for intercurrent illnesses, etc.) but will record these medications and control their presence in the final analysis. Furthermore, we will not to exclude children with other co- morbid neurological disorders (e.g. seizure disorder may be present in up to 25% of autistic patients). We will record these conditions and use them in the predictor model to understand their relationship with our current management protocol.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
2 Years
Maximum Age:
10 Years
Study:
NCT01230359
Study Brief:
Protocol Section:
NCT01230359