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

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2014 by University of North Carolina, Chapel Hill
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Linmarie Sikich, MD, University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier:
NCT01944046
First received: June 13, 2013
Last updated: August 12, 2014
Last verified: August 2014

June 13, 2013
August 12, 2014
August 2014
October 2017   (final data collection date for primary outcome measure)
  • Change in ABC-SW subscale--Reciprocal Social Behavior [ Time Frame: Baseline- 2-4-6-8-10-12 -18 months ] [ Designated as safety issue: No ]
    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.
  • Change in Sociability Factor (SF) [ Time Frame: Baseline-2-4-6-8-10-12-18 ] [ Designated as safety issue: No ]
    The other primary measure is the Sociability Factor (SF), a combined measure derived from 13 items of the ABC-SW, which primarily captures aloof, and avoidant behaviors, and the Pervasive Developmental Disorders Behavior Inventory-Screening Version (PDDBI-SV).
Same as current
Complete list of historical versions of study NCT01944046 on ClinicalTrials.gov Archive Site
  • Change in SRS-Social Motivation Subscale [ Time Frame: Baseline-3-6-9-12-18 months ] [ Designated as safety issue: No ]
    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.
  • Change in Stanford Binet-5th Edition (SB-5)/Mullen [ Time Frame: Baseline-6-12-18 months ] [ Designated as safety issue: No ]
    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.
  • Change in Vineland II Adaptive Behavior Composite and all its subscales [ Time Frame: Baseline-3-6-9-12-18 months ] [ Designated as safety issue: No ]
    Functional skills including communication will be assessed using the standard score of the Vineland 2 adaptive behavior composite and all its subscales.
  • Change in Caregiver Strain Questionnaire total and subscale scores [ Time Frame: Baseline-6-12-18 months ] [ Designated as safety issue: No ]
  • Change in Social Opportunity (Questionaire) [ Time Frame: Baseline-18 months inclusive ] [ Designated as safety issue: No ]
    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.
Same as current
  • Changes in Biologic Outcome Measures [ Time Frame: Baseline-2-6-8-12-18 months ] [ Designated as safety issue: Yes ]
    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.
  • Change in CGI-S and analysis in improvement score (CGI-I) [ Time Frame: Baseline-18 months inclusive ] [ Designated as safety issue: No ]
    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.
  • Reading Mind in the Eyes Test (change from baseline and/or previous month) [ Time Frame: Baseline-2-6-8-12-18 months ] [ Designated as safety issue: No ]
    This computerized task consists of a series of pictures of eyes in which the participant needs to determine which emotion the eyes are expressing.
  • Change in CASI from previous month [ Time Frame: Baseline-18 months inclusive ] [ Designated as safety issue: No ]
    Childhood Anxiety Sensitivity Index (CASI): This scale is designed for measuring anxiety sensitivity (i.e., the belief that anxiety symptoms have negative consequence
  • Change in Systematic Longitudinal Adverse Events Scale (SLAES) [ Time Frame: Baseline-18 months inclusive ] [ Designated as safety issue: Yes ]
    Systematic elicitation and screening of adverse events will be completed using the SLAES.
Same as current
 
Study of Oxytocin in Autism to Improve Reciprocal Social Behaviors
Phase II Study of Oxytocin in Autism to Improve Reciprocal Social Behaviors

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.

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.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Autism Spectrum Disorders
  • Drug: Placebo Nasal Spray
    Other Name: Placebo
  • 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
  • Placebo Comparator: Placebo Nasal Spray
    Placebo
    Intervention: Drug: Placebo Nasal Spray
  • Active Comparator: Oxytocin Nasal Spray
    Oxytocin
    Intervention: Drug: Oxytocin Nasal Spray
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
300
October 2017
October 2017   (final data collection date for primary outcome measure)

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 medications or medication doses of risperidone, aripiprazole, other antipsychotic medications, clonidine, guanfacine, stimulants or anti-convulsants within four weeks of randomization
  • Subjects who have had previous chronic treatment with oxytocin
  • Subjects who are currently being treated with an agent that affects brain serotonin levels, including St. John's Wort
  • Subjects who use benzodiazepines on a regular basis (i.e. 3 of 7 days in a week)
  • 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
Both
3 Years to 17 Years
No
Contact: Lindsey M Hazzard, LCSW 1-800-708-0048 aspire@unc.edu
Contact: Cheryl O Alderman, BS 1-800-708-0048 aspire@unc.edu
United States
 
NCT01944046
13-0593, 1U01HD073984
Yes
Linmarie Sikich, MD, University of North Carolina, Chapel Hill
University of North Carolina, Chapel Hill
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Principal Investigator: Linmarie Sikich, MD University of North Carolina, Chapel Hill
University of North Carolina, Chapel Hill
August 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP