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:
2025-12-25 @ 4:16 AM
Ignite Modification Date:
2025-12-25 @ 4:16 AM
NCT ID:
NCT01028820
Eligibility Criteria:
Inclusion Criteria:
* male or female of any race or ethnicity
* ambulatory status (outpatient) at time of consent
* age 10-55 inclusive at time of consent
* clinical diagnosis of autism spectrum disorder and meets screening criteria on the Social Communication Questionnaire as well as either the Autism Diagnostic Observation Schedule (ADOS) or the Autism Diagnostic Interview-Revised (ADI-R) administered by raters trained to research reliability.
* estimated IQ greater than 70 and capable of making an informed decision based on assessment of their understanding and judgment
* Children's Yale-Brown Obsessive Compulsive Scale: Modified for Pervasive Developmental Disorders (PDD-CYBOCS) \> 8 as assessed during telephone screening.
* Free of psychoactive medication for at least: one month for fluoxetine; two weeks for other SSRIs and neuroleptics; and five days for stimulants prior to MRI scanning \[excepting stable doses (greater than three months duration) of anticonvulsant medication for seizure disorder\]
* Currently taking psychoactive medication that is not providing sufficient relief of repetitive behaviors and willing to discontinue all psychoactive medication for the duration of the study.
* Judged reliable for medication compliance and agreeing to keep follow-up study appointments.
Exclusion Criteria:
* Age less than 10 years or greater than 55 years at time of consent
* Estimated IQ less than 70
* Uncontrolled epilepsy (seizure within 6 months prior to consent)
* Presence of medical conditions that might interfere with participation, or where participation would be contraindicated.
* History of neurological injury: head trauma, poorly-controlled seizure disorder (seizure within the preceding six months), stroke, prior neurosurgery, or under the care of a neurologist or neurosurgeon as determined by interview
* History of claustrophobia
* Implanted or irremovable metal in the body (including certain tattoos and permanent make-up).
* Current pregnancy in females
* Inability to communicate satisfactorily and directly (without a translator) in English
* Medical contraindications to aripiprazole therapy as determined by history (including induction of neuroleptic malignant syndrome, dystonic reaction, or known drug allergy)
* Ongoing need for psychoactive medication other than study medication \[excepting stable doses (greater than 3 months duration) of anticonvulsant medication for seizure disorder or diphenhydramine for sleep
* prior history of aripiprazole treatment failure at appropriate doses and duration
* clinically significant low white blood cell count at baseline
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
10 Years
Maximum Age:
55 Years
Study:
NCT01028820
Study Brief:
Protocol Section:
NCT01028820