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 : December 21, 2018
|Condition or disease||Intervention/treatment||Phase|
|Autism Spectrum Disorders||Drug: Placebo Nasal Spray Drug: Oxytocin Nasal Spray||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||290 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Phase II Study of Oxytocin in Autism to Improve Reciprocal Social Behaviors|
|Actual Study Start Date :||August 1, 2014|
|Actual Primary Completion Date :||November 30, 2017|
|Actual Study Completion Date :||November 30, 2017|
Placebo Comparator: Placebo Nasal Spray
Drug: Placebo Nasal Spray
This nasal spray will contain all of the ingredients that are in the active oxytocin spray in the same quantities, except there will we no oxytocin added to the solution. It will be packaged using the same container system as the active oxytocin nasal spray. Each bottle's label will have its own unique nonsequential randomly assigned number and not a lot number to facilitate masking. Dose titration will occur using exactly the same criteria and procedures as for active study drug.
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.Each bottle's label will have its own unique nonsequential randomly assigned number and not a lot number to facilitate masking.
Other Name: Intranasal Oxytocin
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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
- 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.
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
|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|
|Nashville, Tennessee, United States, 37212|
|United States, Washington|
|Seattle Children's Hospital Research Institute|
|Seattle, Washington, United States, 98105|
|Principal Investigator:||Linmarie Sikich, MD||Duke University|