Intranasal Oxytocin in the Treatment of Autism

2014-08-26 22:37:52 | BioPortfolio


The purpose of this study is to learn whether or not the drug called Oxytocin is helpful in improving mood and social functioning in adults with autism.


Definition: Extended description of the protocol, including information not already contained in other fields, such as comparison(s) studied.

Autism is a developmental disorder characterized by abnormalities in speech and communication, impaired social functioning, and repetitive behaviors and restricted interests (American Psychiatric Association, 2000). A number of researchers have suggested that the neuropeptide oxytocin may be implicated in the etiology of autism (Hollander et al., 2003; Insel et al., 1999; Lim et al., 2005; McCarthy & Altemus, 1997; Modahl et al., 1992; Waterhouse et al., 1996).

Given the likely possibility of dysregulated oxytocin in autism, the goal of this pilot study is to investigate the long-term therapeutic effects of oxytocin in the treatment of autism. One practical issue with oxytocin is that it does not exist in a pill form. Only the intravenous form is available in the US and this form may or may not pass the blood-brain barrier. In addition, IV oxytocin is not practical for treatment studies. One alternative is intranasal oxytocin; this form of administration is known to pass the blood-brain barrier, and it is easy for participants to self-administer. Although not available in the US, we are in the process of receiving an IND exemption for its use and can import it from Europe.

Thus, this pilot investigation will explore daily intranasal oxytocin in the treatment of autism. Also, there are very few, if any, outcome measures to assess social functioning in the "real world" in the context of clinical trials; yet, this is a major target for intervention, especially in autism. Thus, a final goal of this study will be to explore the use of Event Contingent Recording (ECR) to index changes in social functioning and affect. ECR is a methodology developed by personality/social psychologists, which allows participants to report on symptoms, affect, and behavior close in time to experience. In addition, to enabling more sensitive assessments, this methodology allows for the assessment of more diverse (e.g., at home versus work) and more detailed measurements of mood and behavior.

Finally, a portion of this study aims to perform gene expression profiling using fresh whole blood to explore the molecular mechanisms underlying oxytocin therapy and oxytocin efficacy in adults with high functioning autism or Asperger's syndrome. The systemic effects of oxytocin therapy and the molecular basis for a positive treatment response to oxytocin are not well understood. An understanding of the former may help predict those persons who may suffer side-effects from treatment and the latter may help provide easily accessible peripheral biomarkers that could predict treatment response.

Study Design

Allocation: Randomized, Control: Placebo Control, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment






Mount Sinai School of Medicine
New York
New York
United States




Mount Sinai School of Medicine

Results (where available)

View Results


Published on BioPortfolio: 2014-08-26T22:37:52-0400

Clinical Trials [264 Associated Clinical Trials listed on BioPortfolio]

Intranasal Oxytocin for the Treatment of Children and Adolescents With ASD (OXY)

Extensive data has been accumulated to suggest that central release of oxytocin is important for social cognition and function, as well as likely involved in anxiety modulation and repetit...

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The Effect of Oxytocin on the Gastric Emptying

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PubMed Articles [652 Associated PubMed Articles listed on BioPortfolio]

The oxytocin-CD38-vitamin A axis in pregnant women involves both hypothalamic and placental regulation.

Oxytocin, a hypothalamic hormone secreted upon release of ectoenzyme CD38, plays a vital role in interpersonal bonding behaviors. Reduced plasma oxytocin characterizes autistic individuals. CD38 level...

Genetic modulation of oxytocin sensitivity: a pharmacogenetic approach.

Intranasal administration of the neuropeptide oxytocin has been shown to influence a range of complex social cognitions and social behaviors, and it holds therapeutic potential for the treatment of me...

Oxytocin enhances attentional bias for neutral and positive expression faces in individuals with higher autistic traits.

There is considerable interest in the potential therapeutic role of the neuropeptide oxytocin in altering attentional bias towards emotional social stimuli in psychiatric disorders. However, it is sti...

Association between Blood Level of Plasma Oxytocin and Novelty Seeking among Methadone-Maintained Heroin Users.

Oxytocin interacts with the dopaminergic system, which plays a role in addiction behaviors. The association between oxytocin and addiction was confirmed in animal studies. Novelty seeking is one of th...

Judicious use of oxytocin augmentation for the management of prolonged labor.

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Medical and Biotech [MESH] Definitions

Cell surface proteins that bind oxytocin with high affinity and trigger intracellular changes which influence the behavior of cells. Oxytocin receptors in the uterus and the mammary glands mediate the hormone's stimulation of contraction and milk ejection. The presence of oxytocin and oxytocin receptors in neurons of the brain probably reflects an additional role as a neurotransmitter.

A childhood disorder predominately affecting boys and similar to autism (AUTISTIC DISORDER). It is characterized by severe, sustained, clinically significant impairment of social interaction, and restricted repetitive and stereotyped patterns of behavior. In contrast to autism, there are no clinically significant delays in language or cognitive development. (From DSM-IV)

A nonapeptide hormone released from the neurohypophysis (PITUITARY GLAND, POSTERIOR). It differs from VASOPRESSIN by two amino acids at residues 3 and 8. Oxytocin acts on SMOOTH MUSCLE CELLS, such as causing UTERINE CONTRACTIONS and MILK EJECTION.

Carrier proteins for OXYTOCIN and VASOPRESSIN. They are polypeptides of about 10-kDa, synthesized in the HYPOTHALAMUS. Neurophysin I is associated with oxytocin and neurophysin II is associated with vasopressin in their respective precursors and during transportation down the axons to the neurohypophysis (PITUITARY GLAND, POSTERIOR).

A hypothalamic tripeptide, enzymatic degradation product of OXYTOCIN, that inhibits the release of MELANOCYTE-STIMULATING HORMONES.

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