Study of Oxytocin in Autism to Improve Reciprocal Social Behaviors (SOARS-B)
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.
Autism Spectrum Disorders
Drug: Placebo Nasal Spray
Drug: Oxytocin Nasal Spray
|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|
- 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).
- 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.
- 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.
|Study Start Date:||February 2014|
|Estimated Study Completion Date:||August 2017|
|Estimated Primary Completion Date:||August 2017 (Final data collection date for primary outcome measure)|
Placebo Comparator: Placebo Nasal Spray
Drug: Placebo Nasal Spray
Other Name: Placebo
Active Comparator: Oxytocin Nasal Spray
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
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01944046
|Contact: Lindsey M Hazzard, LCSWemail@example.com|
|Contact: Cheryl O Alderman, BSfirstname.lastname@example.org|
|United States, Massachusetts|
|Lurie Center for Autism, Massachusetts General Hospital||Not yet recruiting|
|Boston, Massachusetts, United States, 02114|
|Principal Investigator: Christopher McDougle, MD|
|United States, New York|
|Mount Sinai School of Medicine||Not yet 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||Not yet recruiting|
|Chapel Hill, North Carolina, United States, 27517|
|Principal Investigator: Linmarie Sikich, MD|
|Duke University , Genetics Center||Not yet recruiting|
|Durham, North Carolina, United States, 27710|
|Principal Investigator: Simon Gregory, PhD|
|United States, Tennessee|
|Vanderbilt University||Not yet 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||Not yet recruiting|
|Seattle, Washington, United States, 98105|
|Principal Investigator: Bryan King, MD|
|Principal Investigator:||Linmarie Sikich, MD||University of North Carolina, Chapel Hill|