Study of Oxytocin in Autism to Improve Reciprocal Social Behaviors

What Was Tested

The trial (phase 2) is built around Oxytocin.

This study will also provide additional information about the safety and tolerability of intranasal oxytocin.

It had three arms (groups): DB Placebo Nasal Spray (placebo comparator), DB Oxytocin Nasal Spray (active comparator) and open label intranasal oxytocin (active comparator).

Placebo treatment during weeks 0-24 double blind phase.

DB Oxytocin- quadruply masked treatment with intranasal oxytocin during weeks 0-24 of study during double blind phase of study.

Non masked treatment with intranasal oxytocin from weeks 24-48 in those participants who completed first 24 weeks of double blind treatment.

The registry classes the interventions as drug.

More on the Plan

SOARS-B will also provide information about the regulation of DNA methylation and transcription of the oxytocin receptor gene (OXTR), as well as other genes relevant to oxytocin's CNS activity, as a function of time and in response to oxytocin treatment.

These data will fill a key gap in their understanding of oxytocin's role in ASD and its ability to alter epigenetic modifications of the OXTR.

Who Took Part

Enrollment: 290 actual participants took part.

It was open to people of any sex aged from 3 years up to 17 years.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Be between the ages of 3 years 0 months and 17 years 11 months at the time of randomization. Be diagnosed by clinician experienced in assessment of ASD with autistic disorder, Asperger's syndrome, or PDD-NOS using DSM-V-TR criteria. Must have clinical diagnosis of ASD confirmed using the Autism Diagnostic Observation Scale (ADOS, Lord et al., 2001). Have a guardian who is able to provide informed consent. If cognitively able, subject must be able to provide informed assent/consent.

The full record lists 6 inclusion and 8 exclusion criteria; among the exclusions: have active cardiovascular disease or renal disease that is not controlled by medication; subjects who are pregnant, lactating, or who refuse to practice contraception if sexually active; subjects who have had changes in psychiatric medications within 4 weeks of randomization.

How the Study Was Run

Design: randomized, parallel-group and quadruple-blind.

The participants were allocated by chance, so the Oxytocin group and the comparison group should start out alike.

Groups ran in parallel: each of the participants stayed in one arm throughout.

As a double-blind Oxytocin study, the assignments were hidden from both participants and investigators until the end.

Those kept unaware of assignments: participant, care provider, investigator and outcomes assessor.

It started in 2014-08-01 with completion listed for 2017-11-30.

It ran at 7 sites in United States (7).

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Change in Aberrant Behavior Checklist-Modified Social Withdrawal Subscale ABC-mSW, a Measure of Social Reciprocity (time frame: Least Mean Squares Double-blind phase: change from baseline to week 24). Change in Aberrant Behavior Checklist-Modified Social Withdrawal Subscale ABC-mSW, a Measure of Social Reciprocity (time frame: Least mean squares for Open Label: Change between weeks 24-48).

It also tracked 3 secondary outcomes, for example Change in Sociability Factor (SF), Change in Social Responsiveness Scale-2 (SRS-2) Social Motivation Subscale Score and Change in Stanford Binet-5th Edition (SB-5) IQ Score.

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Oxytocin in 290 people.

The trial is marked completed; results are posted on the registry, and this page does not restate them.

More context: the Oxytocin compound page, all human trials.