The treatments targeting the hormone of social behavior are promising with autism

A hormone-based treatment could improve social function in people with autism, suggest two new clinical trials.

Both focused on vasopressin, a hormone involved in the brain's ability to manage social behavior.

In the first trial, vasopressin nasal spray helped improve the social responsiveness of children with autism, said lead researcher Karen Parker. She is Director of the Social Neuroscience Research Program at Stanford University.

"Parents have seen improvement, clinicians have seen improvement, and children's performance in lab tests has also improved with vasopressin compared to placebo," Parker said.

The second clinical trial was not focused on vasopressin, but on a new drug that activates the hormone-targeted brain receptors, explained the chief investigator, Dr. Paulo Fontoura. He is Executive Vice President of Clinical Development for Neurosciences and Rare Diseases at Roche Pharmaceuticals.

Men with autism spectrum disorder (ASD) who took the drug, balovaptan, showed a clinically significant improvement in their social behaviors, the researchers reported.

Balovaptan has the potential "to improve the basic characteristics of social interaction and communications in adults with ASD," said Fontoura in a statement.

According to Parker, previous animal and human research has shown that vasopressin helps promote social behavior in mammals.

"We have shown that vasopressin is poor in cerebrospinal fluid [among people with autism]And the lower your vasopressin levels, the greater the severity of your symptoms, "said Parker. If we examine the location of vasopressin receptors in the brain, they are located in socially relevant areas identified as regulating social functioning. "

Parker and his colleagues treated 17 autistic children for four weeks with a vasopressin nasal spray and 13 other children with an inactive placebo spray.

Children treated with vasopressin exhibited improved social behavior as measured by a standardized test called the social responsiveness scale. They also showed an improvement in social communication, were better able to interpret the emotional and mental states of others and exhibited a decrease in symptoms related to autism, such as anxiety and anxiety. repetitive behaviors.

The clinical trial on balovaptan involved 223 men with moderate or severe autism, the researchers said.

The patients were divided into four groups and received either balovaptan at different doses or placebo daily for 12 weeks.

Men did not show significant improvement as measured by the scale of social responsiveness, according to the study's authors.

But the two groups of patients who received higher doses of balovaptan showed improvements, measured by another scale evaluating socialization, adaptive behavior and life skills, compared to those given placebo.

Vasopressin and balovaptan have not caused serious side effects or safety concerns, Parker and Fontoura said.

Dr. Andrew Adesman, Head of Developmental and Behavioral Pediatrics at Cohen Children's Medical Center in New Hyde Park, NY, has mixed feelings about the treatment of autism with vasopressin.

"These two studies, considered together, suggest that treatments to increase vasopressin levels in the brain might be helpful for some patients with ASD," said Adesman. "However, much more research is needed on the long-term benefits and safety of this type of treatment."

Vasopressin is already available on prescription, as an antidiuretic used to treat overly frequent urination. For this reason, Adesman is concerned that parents may be tempted to ask their doctor for a non-compliant prescription for their autistic child.

"I think families and doctors should use this medication with caution based on only one short-term study," Adesman said.

"Since there are very few, if any, drugs for the treatment of ASD, I am confident that this new therapeutic approach will be of great interest," said Adesman. "That said, I think that much more research is needed before we can feel comfortable recommending vasopressin as a safe and effective treatment for one of the major deficits in children with ASD. "

Both studies moved on to the next stage of the clinical trial.

Vasopressin is currently being tested in a larger group of 100 children, Parker said.

Balovaptan is at the center of two clinical trials, a phase II study in children and adolescents and a phase III trial in adults, said Fontoura.

The latest results were published on May 1 in the journal Translational medicine science.

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