Intranasal Oxytocin Treatment for Social Deficits in Children With Autism
| Status: | Completed |
|---|---|
| Conditions: | Neurology, Psychiatric, Autism |
| Therapuetic Areas: | Neurology, Psychiatry / Psychology |
| Healthy: | No |
| Age Range: | 6 - 12 |
| Updated: | 7/5/2018 |
| Start Date: | June 2012 |
| End Date: | May 2016 |
Double-blind, Randomized, Placebo Controlled Trial of Intranasal Oxytocin Treatment for Social Deficits in Children With Autism.
Autism is a pervasive developmental disorder characterized by core deficits in social
behavior and communication, and the presence of repetitive or stereotyped behaviors. It is
one of three recognized disorders in the autism spectrum which affects an estimated 1 in 88
children in the United States. At present, pharmacotherapies target only associated features
of autism, with no effective drug treatments for the social impairments. Several lines of
evidence now suggest that the neuropeptide oxytocin (OT) may be an effective treatment for
the core social deficits in autism. Here we will test the effects of twice daily intranasal
OT (24 IU) over a 4-week period for enhancing social deficits in male and female children
aged 6-12 years with autism. This research has high potential to lead to the development of
more effective treatments and earlier interventions for children with autism.
behavior and communication, and the presence of repetitive or stereotyped behaviors. It is
one of three recognized disorders in the autism spectrum which affects an estimated 1 in 88
children in the United States. At present, pharmacotherapies target only associated features
of autism, with no effective drug treatments for the social impairments. Several lines of
evidence now suggest that the neuropeptide oxytocin (OT) may be an effective treatment for
the core social deficits in autism. Here we will test the effects of twice daily intranasal
OT (24 IU) over a 4-week period for enhancing social deficits in male and female children
aged 6-12 years with autism. This research has high potential to lead to the development of
more effective treatments and earlier interventions for children with autism.
In recent years, the neuropeptide oxytocin (OT) has been implicated in a wide range of social
behaviors including attachment bonds, emotion recognition, eye gaze to social cues, and
memory for social information. Social impairments represent one of the most intractable
features of autism, and evidence now suggests that OT biology is dysregulated in individuals
with this disorder. The central aim of the research outlined here is to test whether OT
administration to children with autism increases their quality and quantity of social
interactions and enhances their ability to process emotional and social information. Findings
from initial single-dose OT administration studies in teenaged and adult males with autism
have shown improvement in some aspects of social functioning, but replication and extension
to well-controlled treatment trials with younger male and female subjects is necessary to
evaluate effectiveness. We therefore aim to investigate the effect of intranasal OT on social
cognition and behavior immediately following a single-dose (24IU) and following a 4-week
period of OT (24IU BID) administration in a sample of 50 subjects with autism aged 6 to 12
years. The primary outcome for this study is change in social behavior, as determined by
parent ratings on the Social Responsiveness Scale (SRS) after the 4-week treatment period.
Secondary outcomes are changes in functioning on laboratory-based measures of social behavior
and cognition following single-dose and 4-week OT administration. Research in a small study
sample (N=13) also identified treatment responders and non-responders to a single-dose of OT.
Thus, we also aim to identify biological and cognitive and behavioral variables (i.e.,
pretreatment levels of social functioning and pretreatment plasma hormone levels) that may
influence treatment response efficacy in our larger study sample. On completion of the 4-week
treatment period all subjects will have the option of participating in another 4-week
double-blind trial in which they will be switched to the alternate nasal spray to that which
they previously received. They will then undergo a fourth and final assessment time-point
using the same testing procedures as outlined above on completion of the 4-week dosing. By
providing subjects with the option of participating in a second 4-week treatment trial, all
subjects will have an opportunity to receive the active oxytocin nasal spray. We also will be
able to examine any ongoing effects of oxytocin treatment in the group receiving placebo
during the second 4-week administration period. Subjects not willing to take part in the
second trial will exit the study and will be referred to their treating physician.
behaviors including attachment bonds, emotion recognition, eye gaze to social cues, and
memory for social information. Social impairments represent one of the most intractable
features of autism, and evidence now suggests that OT biology is dysregulated in individuals
with this disorder. The central aim of the research outlined here is to test whether OT
administration to children with autism increases their quality and quantity of social
interactions and enhances their ability to process emotional and social information. Findings
from initial single-dose OT administration studies in teenaged and adult males with autism
have shown improvement in some aspects of social functioning, but replication and extension
to well-controlled treatment trials with younger male and female subjects is necessary to
evaluate effectiveness. We therefore aim to investigate the effect of intranasal OT on social
cognition and behavior immediately following a single-dose (24IU) and following a 4-week
period of OT (24IU BID) administration in a sample of 50 subjects with autism aged 6 to 12
years. The primary outcome for this study is change in social behavior, as determined by
parent ratings on the Social Responsiveness Scale (SRS) after the 4-week treatment period.
Secondary outcomes are changes in functioning on laboratory-based measures of social behavior
and cognition following single-dose and 4-week OT administration. Research in a small study
sample (N=13) also identified treatment responders and non-responders to a single-dose of OT.
Thus, we also aim to identify biological and cognitive and behavioral variables (i.e.,
pretreatment levels of social functioning and pretreatment plasma hormone levels) that may
influence treatment response efficacy in our larger study sample. On completion of the 4-week
treatment period all subjects will have the option of participating in another 4-week
double-blind trial in which they will be switched to the alternate nasal spray to that which
they previously received. They will then undergo a fourth and final assessment time-point
using the same testing procedures as outlined above on completion of the 4-week dosing. By
providing subjects with the option of participating in a second 4-week treatment trial, all
subjects will have an opportunity to receive the active oxytocin nasal spray. We also will be
able to examine any ongoing effects of oxytocin treatment in the group receiving placebo
during the second 4-week administration period. Subjects not willing to take part in the
second trial will exit the study and will be referred to their treating physician.
Inclusion Criteria:
- Medically healthy outpatients between 6 and 12 years of age (cut off 12 years and 11
months)
- Intelligence Quotient > 40
- Diagnosis of autism spectrum disorder based on the Autism Diagnostic Interview -
Revised, Autism Diagnostic Observation Schedule, and DSM-IV criteria
- Clinical Global Impression severity rating of 4 or higher
- Care provider who can reliably bring subject to clinic visits, provide trustworthy
ratings, and interacts with the subject on a regular basis
- Stable medications for at least 4 weeks
- No planned changes in psychosocial interventions during the trial
- Willingness to provide blood samples.
Exclusion Criteria:
- Diagnostics and Statistical Manual of Mental Disorders, 4th edition (DSM-IV) diagnosis
of schizophrenia, schizoaffective disorder, or psychotic disorder
- Regular nasal obstruction or nosebleeds
- Active medical problems: unstable seizures, significant physical illness (e.g.,
serious liver, renal, or cardiac pathology)
- Sensitivity to preservatives (in particular E 216, E 218, and chlorobutanol
hemihydrate)
- A genetic abnormality (e.g., Fragile X Syndrome)
- Significant hearing or vision impairments
- Habitually drinks large volumes of water
- Pregnancy, breastfeeding, or child birth within the last 6 months
- Sexually active females not using a reliable method of contraception.
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