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 @ 7:07 PM
Ignite Modification Date:
2025-12-24 @ 7:07 PM
NCT ID:
NCT01945957
Eligibility Criteria:
Inclusion Criteria:
* Between 6 and 18 years of age, inclusive
* Have a clinical diagnosis of an autism spectrum disorder confirmed according to the Autism Diagnostic Observation Scale (ADOS, Lord et al., 1989). Diagnosis may also be confirmed using the Autism Diagnostic Interview-Revised (ADI-R).
* Male or female of any race or ethnicity
* Ambulatory status (outpatient) at time of assent/consent
* Estimated IQ greater than or equal to 70 and capable of making an informed decision based on assessment of their understanding and judgment
Exclusion Criteria:
* History of neurological injury: head trauma, poorly-controlled seizure disorder (i.e. seizure within the preceding six month period), stroke, prior neurosurgery, or under the care of a neurologist or neurosurgeon as determined by interview
* History of claustrophobia
* Implanted medical devices, implanted metal debris, shrapnel, certain tattoos, or permanent makeup that is contraindicated for MRI. Participants fill out a detailed questionnaire on the day of scanning to identify potential MRI risks
* Subjects with a medical condition that might interfere with the conduct of the study, confound interpretation of the study results, or endanger their own well-being. This includes, but is not limited to: Rett Syndrome, impairment of renal function, evidence or history of malignancy or any significant hematological, endocrine, cardiovascular (including any rhythm disorder or uncontrolled hypertension), respiratory, hepatic, or gastrointestinal disease
* Marked sensory impairment such as deafness or blindness that would interfere with the conduct of the study
* Pregnant or nursing because of the unknown effects of oxytocin to unborn babies and/or nursing infants. All females of child-bearing potential will be administered a serum pregnancy test at screening and at any point during the study at physician discretion. Refusal to undergo a pregnancy test will result in exclusion from the study. We will share results of a pregnancy test with the subject's legal guardian.
* Refusal to do pregnancy testing with understanding that guardian will be informed of positive test results
* Inability or refusal of sexually active female subjects (who have begun menses) to utilize two medically accepted barrier forms of birth control
* Use of hormonal birth control
* Subjects who have a history of an anaphylactic reaction from prior treatment with oxytocin (nasal spray)
* Inability of caretakers to speak English
* Absence of a consistent caretaker to report on symptoms
* Subjects who, in the Investigator's opinion, might not be suitable for the study
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
6 Years
Maximum Age:
18 Years
Study:
NCT01945957
Study Brief:
Protocol Section:
NCT01945957