Study Name: A Pilot Study of Oxytocin in Children and Adolescents with Autism
IRB # 11-0493
PI: Linmarie Sikich, MD
Sponsor: Autism Speaks
Contact person: Lindsey Hazzard
The purpose of this research study is to examine the safety and efficacy of oxytocin on social functioning associated with autistic disorder. This is a study in which participants will receive either placebo (fake medicine) or active oxytocin for 2 months. Immediately following this phase all participants will receive active oxytocin for 2 months. There will be a total of 8 office visits: screening, baseline, week 4, week 8, week 12, week 16, week 28, and one other visit due before week 76. There will be 12 phone calls throughout the study. After the initial 4 months, there will be two follow up visits at week 28 and 76 (after study treatment has stopped).
Subjects will be paid $10 for the screening visit (regardless of whether it takes more than one visit to complete screening procedures) and $10 per study visit (Visits 1-7). There will be no compensation for time spent on calls. There will be no additional compensation for travel or meals. Participants who park at the UNC parking garage will be provided with a parking voucher. Study medication and research related services will be free of charge.
Major inclusion criteria
- Between the ages of 3 and 17, male or female, any race or ethnicity
- Clinical diagnosis of autistic disorder
Major exclusion criteria
- Changes in allied health therapies, behavioral or educational interventions within the past 2 months of the baseline visit other than those associated with school holidays
- Changes in psychotropic and alternative medication doses in the last 30 days of the baseline visit
- 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 and uncontrolled hypertension), respiratory, hepatic, or gastrointestinal disease.
- Marked sensory impairment such as deafness or blindness that would interfere with conduct of the study.
- Pregnancy/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 urine or 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 pregnancy test with the subject’s legal guardian.
- Refusal to practice contraception if sexually active because the effects of exposure to high concentrations of oxytocin on sperm or newly conceived embryos are unknown. Sexually active men and women should not take part in this study if they and their partners are not both using an effective birth control method (for example, women use birth control pills, an intrauterine device [IUD] or a diaphragm and men use condoms).
- 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.
Site of study
UNC Neurosciences Hospital
Date enrollment closes
Study Related Resources