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
  Purpose

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 Intervention Phase
Autism Spectrum Disorders
Drug: Placebo Nasal Spray
Drug: Oxytocin Nasal Spray
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Phase II Study of Oxytocin in Autism to Improve Reciprocal Social Behaviors

Resource links provided by NLM:


Further study details as provided by University of North Carolina, Chapel Hill:

Primary Outcome Measures:
  • 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).


Secondary Outcome Measures:
  • 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.


Other Outcome Measures:
  • 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.


Estimated Enrollment: 300
Study Start Date: August 2014
Estimated Study Completion Date: October 2017
Estimated Primary Completion Date: October 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   3 Years to 17 Years
Genders Eligible for Study:   Both
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 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01944046

Contacts
Contact: Lindsey M Hazzard, LCSW 1-800-708-0048 aspire@unc.edu
Contact: Cheryl O Alderman, BS 1-800-708-0048 aspire@unc.edu

Locations
United States, Massachusetts
Lurie Center for Autism, Massachusetts General Hospital Recruiting
Boston, Massachusetts, United States, 02114
Principal Investigator: Christopher McDougle, MD         
United States, New York
Mount Sinai School of Medicine Recruiting
New York, New York, United States, 10029
Contact: Alexander Kolevzon, MD         
Principal Investigator: Alexander Kolevzon, MD         
United States, North Carolina
The University of North Carolina at Chapel Hill, Department of Psychiatry Recruiting
Chapel Hill, North Carolina, United States, 27517
Principal Investigator: Linmarie Sikich, MD         
Duke University , Genetics Center Recruiting
Durham, North Carolina, United States, 27710
Principal Investigator: Simon Gregory, PhD         
United States, Tennessee
Vanderbilt University Recruiting
Nashville, Tennessee, United States, 37212
Sub-Investigator: Jeremy Veenstra-VanderWeele, MD, PhD         
Sub-Investigator: Zachary Warren, PhD         
United States, Washington
Seattle Children's Hospital Research Institute Recruiting
Seattle, Washington, United States, 98105
Principal Investigator: Bryan King, MD         
Sponsors and Collaborators
University of North Carolina, Chapel Hill
Investigators
Principal Investigator: Linmarie Sikich, MD University of North Carolina, Chapel Hill
  More Information

No publications provided

Responsible Party: Linmarie Sikich, MD, Associate Professor, University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier: NCT01944046     History of Changes
Other Study ID Numbers: 13-0593, 1U01HD073984
Study First Received: June 13, 2013
Last Updated: August 12, 2014
Health Authority: United States: Federal Government
United States: Food and Drug Administration
United States: Institutional Review Board

Keywords provided by University of North Carolina, Chapel Hill:
autism, ASD, autistic, Asperger's, PDD-NOS, oxytocin

Additional relevant MeSH terms:
Autistic Disorder
Child Development Disorders, Pervasive
Mental Disorders Diagnosed in Childhood
Mental Disorders
Oxytocin
Oxytocics
Reproductive Control Agents
Physiological Effects of Drugs
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on September 22, 2014