Intranasal Oxytocin for the Treatment of Autism Spectrum Disorders
| Status: | Completed |
|---|---|
| Conditions: | Neurology, Psychiatric, Autism |
| Therapuetic Areas: | Neurology, Psychiatry / Psychology |
| Healthy: | No |
| Age Range: | 18 - 55 |
| Updated: | 10/14/2017 |
| Start Date: | October 2009 |
| End Date: | December 2013 |
Autism Spectrum Disorder (ASD) is a developmental disorder characterized by abnormalities in
speech and communication, impaired social functioning and repetitive behaviors and restricted
interests. Oxytocin (OT) is peptide that is known for its peripheral effects on facilitating
uterine contractions and milk let-down; however, studies, mainly with rodents and non-human
primates, has found that OT is involved in affiliative behaviors, including sexual behavior,
mother-infant and adult-adult pair-bond formation, separation distress, and other aspects of
social attachment. Moreover, OT is known to play an important role in repetitive behaviors
and stress reactivity. Given that repetitive behaviors and deficits in social interaction are
core symptom domains of autism, and that OT is involved in the regulation of repetitive and
affiliative behaviors, it is believed that OT may play a role in the etiology of autism.
Moreover, preliminary data obtained by Hollander and colleagues suggests that OT may be of
value in treating core autism symptoms. Specifically, synthetic oxytocin administered via
intravenous infusion to adults with autism spectrum disorders (ASD) produced significant
reductions in repetitive behaviors and facilitated social cognition/memory in a double-blind,
placebo-controlled cross-over laboratory challenge.
Encouraged by these findings, the primary aim of this study is to investigate the safety and
therapeutic efficacy of intranasal OT in treating repetitive behaviors and social
functioning/cognitive deficits in adults with ASD. This research embraces a translational
approach to develop a novel treatment for core ASD symptoms; given that there are currently
no Food and Drug Administration (FDA) approved medication treatments for core ASD symptoms,
this research addresses an important unmet need in the field. The goal of this study is to
evaluate the safety and efficacy of repeated Intranasal Oxytocin Treatment
(INOT)administration in adults with ASD.
speech and communication, impaired social functioning and repetitive behaviors and restricted
interests. Oxytocin (OT) is peptide that is known for its peripheral effects on facilitating
uterine contractions and milk let-down; however, studies, mainly with rodents and non-human
primates, has found that OT is involved in affiliative behaviors, including sexual behavior,
mother-infant and adult-adult pair-bond formation, separation distress, and other aspects of
social attachment. Moreover, OT is known to play an important role in repetitive behaviors
and stress reactivity. Given that repetitive behaviors and deficits in social interaction are
core symptom domains of autism, and that OT is involved in the regulation of repetitive and
affiliative behaviors, it is believed that OT may play a role in the etiology of autism.
Moreover, preliminary data obtained by Hollander and colleagues suggests that OT may be of
value in treating core autism symptoms. Specifically, synthetic oxytocin administered via
intravenous infusion to adults with autism spectrum disorders (ASD) produced significant
reductions in repetitive behaviors and facilitated social cognition/memory in a double-blind,
placebo-controlled cross-over laboratory challenge.
Encouraged by these findings, the primary aim of this study is to investigate the safety and
therapeutic efficacy of intranasal OT in treating repetitive behaviors and social
functioning/cognitive deficits in adults with ASD. This research embraces a translational
approach to develop a novel treatment for core ASD symptoms; given that there are currently
no Food and Drug Administration (FDA) approved medication treatments for core ASD symptoms,
this research addresses an important unmet need in the field. The goal of this study is to
evaluate the safety and efficacy of repeated Intranasal Oxytocin Treatment
(INOT)administration in adults with ASD.
Inclusion Criteria:
- Male and Female
- 18 to 55 years old
- Meet DSM-IV, ADOS, and ADI-R standards for Autism Spectrum Disorder or Aspergers
Syndrome
- Have a high, normal or near normal IQ
- Speak and Understand English fluently
Exclusion Criteria:
- Born prior to 35 weeks gestational age
- Any primary psychiatric diagnosis other than autism at the time of screening
- Medical history of neurological disease
- Medical history of known MRI/structural lesion of the brain
- Patients who are pregnant
- With a medical condition that might interfere with the conduct of the study, confound
interpretation of study results or endanger their own well being
- With evidence or history of malignancy or any significant hematological, endocrine,
cardiovascular, respiratory, renal, hepatic or gastrointestinal disease
- Taking psychoactive medications
- Who plan to initiate or change nonpharmacologic interventions during the study course
- Who are unable to tolerate venipuncture procedures for blood sampling
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