Study of Oxytocin in Autism to Improve Reciprocal Social Behaviors (SOARS-B)

Linmarie Sikich

Status and phase: Completed; Phase 2

Conditions: Autism Spectrum Disorders

Treatments: Drug: Double blind phase Placebo Nasal Spray; Drug: double Blind Oxytocin Nasal Spray; Drug: Open Label intranasal oxytocin

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT01944046

13-0593 (Other Identifier)

Pro00063950

1U01HD073984 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

The purpose of this research study is to learn about the effects of supplemental intranasal oxytocin as a treatment for improving social difficulties in children and adolescents with autism. This study will also provide additional information about the safety and tolerability of intranasal oxytocin. Investigators expect oxytocin will increase social motivation, improving daily living skills and quality of life.

Full description

There is a tremendous unmet need for accessible treatments that address core symptoms of ASD and are safe for sustained use. The Study of Oxytocin in ASD to improve Reciprocal Social Behaviors or (SOARS-B) will test a very promising potential treatment-intranasal oxytocin-for ASD's fundamental social communication deficits in a large, group of verbal and nonverbal children. 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 our understanding of oxytocin's role in ASD and its ability to alter epigenetic modifications of the OXTR.

Enrollment: 290 patients

Sex: All

Ages: 3 to 17 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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)
• Must have clinical diagnosis of ASD confirmed using the Autism Diagnostic Interview-Revised (ADI-R, Rutter, 2003). ASD criteria proposed by Risi (2006). Specifically, subject must be within 1 point of autism criteria on both social and communication domains of the ADI or meet autism criteria in one of these ADI domains and come within 2 points of autism criteria in the other
• Have a guardian who is able to provide informed consent
• If cognitively able, subject must be able to provide informed assent/consent

Exclusion criteria

• Have a known diagnosis of Rett Syndrome or Childhood Disintegrative Disorder, or have marked sensory impairment such as deafness or blindness
• 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 allied health therapies, behavioral or educational interventions within the two months prior to randomization other than those associated with school holidays
• Subjects who have had changes in psychiatric medications within 4 weeks of randomization
• Subjects who have had previous chronic treatment with oxytocin
• Subjects who have caretakers who are unable to speak English, be consistently present at visits to report on symptoms, or are otherwise judged as unable to comply with the protocol by the data collection site team
• Subjects with active seizures within the 6 months preceding screening or baseline -added part way through study in response to subject death.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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290 participants in 3 patient groups, including a placebo group

DB Placebo Nasal Spray

Placebo Comparator group

Description:

Placebo treatment during weeks 0-24 double blind phase

Treatment:

Drug: Double blind phase Placebo Nasal Spray

DB Oxytocin Nasal Spray

Active Comparator group

Description:

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

Treatment:

Drug: double Blind Oxytocin Nasal Spray

open label intranasal oxytocin

Active Comparator group

Description:

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

Treatment:

Drug: Open Label intranasal oxytocin