Intranasal Oxytocin in the Treatment of Autism

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

Summary

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.

Description

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

Conditions

Autism

Intervention

Oxytocin

Location

Mount Sinai School of Medicine
New York
New York
United States
10029-6574

Status

Recruiting

Source

Mount Sinai School of Medicine

Results (where available)

View Results

Links

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

Clinical Trials [230 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...

Effects of Prosocial Neuropeptides on Human Brain Function in Healthy Volunteers and Individuals With Autism Spectrum Disorders.

Background: - Oxytocin and vasopressin are two hormones produced in the brain. Both hormones can influence activity in brain regions such as the amygdala that are involved in social and ...

Comparison of Low-dose and High-dose Oxytocin Regimens for Labor Augmentation

Oxytocin is a medication that is often used to strengthen contractions to overcome delayed labor progress. The primary aim of this study is to determine whether receiving a higher dose of...

The Effect of Oxytocin on Gastric Emptying

The investigators have seen that oxytocin lowers satiety in healthy subjects. Patients with dyspepsia suffers from decreased accommodation and increased satiety postprandially. The investi...

The Effect of Oxytocin on the Gastric Emptying

The investigators are going to examine whether oxytocin has a prokinetic effect on gastric emptying in patients suffering from gastro paresis. Oxytocin infusion will be compared with sodiu...

PubMed Articles [582 Associated PubMed Articles listed on BioPortfolio]

Oxytocin increases eye contact during a real-time, naturalistic social interaction in males with and without autism.

Autism spectrum conditions (autism) affect ~1% of the population and are characterized by deficits in social communication. Oxytocin has been widely reported to affect social-communicative function an...

Oxytocin Restores Sociability in a Mouse Model of Autism.

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...

The Contractile Effects of Oxytocin, Ergonovine, and Carboprost and Their Combinations: An In Vitro Study on Human Myometrial Strips.

The objective of this study was to compare the in vitro contractile effects of the combination of oxytocin (low dose and high dose) with either ergonovine or carboprost in myometrial strips from women...

Oxytocin affects the connectivity of the precuneus and the amygdala: A randomized double-blinded placebo-controlled neuroimaging trial.

Although oxytocin is one of the most widely studied neuropeptides in recent times, the mechanistic process by which it modulates social-affective behaviour in the brain is not yet clearly understood. ...

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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