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

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ClinicalTrials.gov Identifier: NCT01944046
Recruitment Status : Completed
First Posted : September 17, 2013
Last Update Posted : January 23, 2018
Sponsor:
Collaborator:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Information provided by (Responsible Party):
Linmarie Sikich, Duke University

Study Description
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
The purpose of this research study is to learn about the effects of intranasal oxytocin as a supplemental 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.

Condition or disease Intervention/treatment Phase
Autism Spectrum Disorders Drug: Placebo Nasal Spray Drug: Oxytocin Nasal Spray Phase 2

Detailed 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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 290 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Phase II Study of Oxytocin in Autism to Improve Reciprocal Social Behaviors
Study Start Date : August 2014
Actual Primary Completion Date : November 30, 2017
Actual Study Completion Date : November 30, 2017

Resource links provided by the National Library of Medicine

Drug Information available for: Oxytocin
U.S. FDA Resources

Arms and Interventions
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Arm Intervention/treatment
Placebo Comparator: Placebo Nasal Spray
Placebo
 Drug: Placebo Nasal Spray
Other Name: Placebo
Active Comparator: Oxytocin Nasal Spray
Oxytocin
 Drug: Oxytocin Nasal Spray
Each insufflation will deliver 8 IU or 24 IU of oxytocin. A maximum of 3 insufflations at a time will be required. Dosing will be flexible between 8 IU/day and 80 IU/day, typically in two divided doses delivered in the morning and in the afternoon. Doses will typically increase by 8 IU twice daily (BID) at week 2 and months 1 and 2 until achieving the target dose of 24 IU BID at Month 2. Subsequently doses may be increased in 8 IU BID increments ONLY at each visit until a maximum dose of 40 IU BID is achieved.
Other Name: Intranasal Oxytocin


Outcome Measures
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Primary Outcome Measures :
  1. Change in ABC-SW subscale--Reciprocal Social Behavior [ Time Frame: Baseline- 2-4-6-8-9/10-12 months ]
    The primary outcome is reciprocal social behaviors, which will be assessed using two co-primary measures. The first measure is the ABC-SW subscale, which is being used in other clinical trials focusing on the core social and communication symptoms of autism.


Secondary Outcome Measures :
  1. Change in SRS-Social Motivation Subscale [ Time Frame: Baseline-3-6-9-12 months ]
    Social Responsiveness Scale (SRS)-Social Motivation subscale, was developed to provide a quantitative measure of social impairments typically observed in ASD in children 3-18 years.

  2. Change in Stanford Binet-5th Edition (SB-5)/Mullen [ Time Frame: Baseline-6 months ]
    Cognitive skills will be assessed using the Stanford Binet-5th Edition (SB-5) (Roid). If a participant cannot complete the routing tests on the SB-5, they will be assessed using the Mullen.

  3. Change in Vineland II Adaptive Behavior Composite and all its subscales [ Time Frame: Baseline-3-6-9-12 months ]
    Functional skills including communication will be assessed using the standard score of the Vineland 2 adaptive behavior composite and all its subscales.

  4. Change in Caregiver Strain Questionnaire total and subscale scores [ Time Frame: Baseline-6-12 months ]
    caregiver questionnaire that assesses the impact of caring for the proband on caregiver and family.

  5. Change in Social Opportunity (Questionaire) [ Time Frame: Baseline-12 months inclusive ]
    This UNC created form asks parents to rate how frequently their child has the opportunity to interact with different individuals in the community, home, school and daycare/after-school setting. It also asks, of those opportunities that their child has, does their child actually utilize those opportunities to interact with individuals in a social manner.


Other Outcome Measures:
  1. Changes in Biologic Outcome Measures [ Time Frame: Baseline-2-6-8-12 months ]
    Investigators will obtain blood, urine and vital signs from participants at regular intervals in order to assess the safety of oxytocin. In addition,the blood samples will also be used to assess oxytocin levels, OTXR differential methylation status and to assess mRNA expression. Investigators will obtain saliva at the same time points to perform salivary oxytocin levels.

  2. Change in CGI-S and analysis in improvement score (CGI-I) [ Time Frame: Baseline-12 months inclusive ]
    The Clinical Global Impressions - Improvement score and Severity score, which is routinely used in pharmacologic clinical trials, will capture the study physician's global impression of response.

  3. Reading Mind in the Eyes Test (change from baseline and/or previous month) [ Time Frame: Baseline-2-6-8-12 months ]
    This computerized task consists of a series of pictures of eyes in which the participant needs to determine which emotion the eyes are expressing.

  4. Change in CASI from previous month [ Time Frame: Baseline-12 months inclusive ]
    Childhood Anxiety Sensitivity Index (CASI): This scale is designed for measuring anxiety sensitivity (i.e., the belief that anxiety symptoms have negative consequence

  5. Change in Systematic Longitudinal Adverse Events Scale (SLAES) [ Time Frame: Baseline-12 months inclusive ]
    Systematic elicitation and screening of adverse events will be completed using the SLAES.


Eligibility Criteria
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Ages Eligible for Study:   3 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01944046


Locations
United States, Massachusetts
Lurie Center for Autism, Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
United States, New York
Mount Sinai School of Medicine
New York, New York, United States, 10029
Center for Autism and the Developing Brain
White Plains, New York, United States, 10605
United States, North Carolina
Duke Center for Autism and Brain Development
Durham, North Carolina, United States, 27705
Duke University , Genetics Center
Durham, North Carolina, United States, 27710
United States, Tennessee
Vanderbilt University
Nashville, Tennessee, United States, 37212
United States, Washington
Seattle Children's Hospital Research Institute
Seattle, Washington, United States, 98105
Sponsors and Collaborators
Linmarie Sikich
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Investigators
Principal Investigator: Linmarie Sikich, MD Duke University
More Information
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party: Linmarie Sikich, Associate professor, Duke University
ClinicalTrials.gov Identifier: NCT01944046     History of Changes
Other Study ID Numbers: Pro00063950
1U01HD073984 ( U.S. NIH Grant/Contract )
13-0593 ( Other Identifier: UNC )
First Posted: September 17, 2013    Key Record Dates
Last Update Posted: January 23, 2018
Last Verified: January 2018

Keywords provided by Linmarie Sikich, Duke University:
autism, ASD, autistic, Asperger's, PDD-NOS, oxytocin

Additional relevant MeSH terms:
Autistic Disorder
Autism Spectrum Disorder
Child Development Disorders, Pervasive
Neurodevelopmental Disorders
Mental Disorders
 Oxytocin
Oxytocics
Reproductive Control Agents
Physiological Effects of Drugs