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
Results First Posted : January 5, 2021
Last Update Posted : January 5, 2021
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Study Type | Interventional |
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Study Design | Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Treatment |
Condition |
Autism Spectrum Disorders |
Interventions |
Drug: Double blind phase Placebo Nasal Spray Drug: double Blind Oxytocin Nasal Spray Drug: Open Label intranasal oxytocin |
Enrollment | 290 |
Recruitment Details | |
Pre-assignment Details |
Arm/Group Title | Oxytocin Nasal Spray | Placebo Nasal Spray |
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Oxytocin 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 weeks 4 and 8 until achieving the target dose of 24 IU BID at week 8. 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. During the open label phase after approximately March 2019 the study used only the 24 IU /0.10 ml formulation and the maximum dose was 72 IU per day. |
Placebo 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 be 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. |
Period Title: Randomized to DB | ||
Started | 146 | 144 |
Completed | 125 | 125 |
Not Completed | 21 | 19 |
Reason Not Completed | ||
Adverse Event | 5 | 2 |
Clinical Worsening | 3 | 2 |
Lost to Follow-up | 3 | 3 |
Withdrawal by Subject | 2 | 4 |
Physician Decision | 1 | 2 |
Did not have baseline ABC-SW | 2 | 0 |
Did not have a postbaseline ABC SW | 5 | 6 |
Period Title: Open Label Eligible and Consented | ||
Started [1] | 124 | 124 |
Completed | 110 | 116 |
Not Completed | 14 | 8 |
Reason Not Completed | ||
Lost to Follow-up | 3 | 5 |
Adverse Event | 6 | 1 |
Clinical Worsening | 4 | 2 |
Withdrawal by Subject | 1 | 0 |
[1]
1 from each treatment group declined to consent for openlabel
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Arm/Group Title | Oxytocin Nasal Spray | Placebo Nasal Spray | Total | |
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Oxytocin 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 weeks 4 and 8 until achieving the target dose of 24 IU BID at week 8. 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. During the open label phase after approximately March 2019 the study used only the 24 IU /0.10 ml formulation and the maximum dose was 72 IU per day. |
Placebo 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 be 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. |
Total of all reporting groups | |
Overall Number of Baseline Participants | 139 | 138 | 277 | |
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Double-Blind Full Analysis Set (FAS). The DB FAS was defined as having both baseline and at least one post-baseline ABC-SW assessment. The DB-FAS excludes 7 participants randomized to oxytocin (2 with no baseline ABC-SW and 5 with no post-baseline ABC-SW) and 6 participants assigned to placebo who had no post-baseline ABC-SW.
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Age, Continuous
Mean (Standard Deviation) Unit of measure: Years |
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Number Analyzed | 139 participants | 138 participants | 277 participants | |
10.4 (4.06) | 10.4 (3.99) | 10.4 (4.04) | ||
Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 139 participants | 138 participants | 277 participants | |
Female |
17 12.2%
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18 13.0%
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35 12.6%
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Male |
122 87.8%
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120 87.0%
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242 87.4%
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Ethnicity (NIH/OMB)
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 139 participants | 138 participants | 277 participants | |
Hispanic or Latino |
13 9.4%
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15 10.9%
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28 10.1%
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Not Hispanic or Latino |
126 90.6%
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123 89.1%
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249 89.9%
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Unknown or Not Reported |
0 0.0%
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0 0.0%
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0 0.0%
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Race (NIH/OMB)
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 139 participants | 138 participants | 277 participants | |
American Indian or Alaska Native |
0 0.0%
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0 0.0%
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0 0.0%
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Asian |
11 7.9%
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12 8.7%
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23 8.3%
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Native Hawaiian or Other Pacific Islander |
0 0.0%
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0 0.0%
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0 0.0%
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Black or African American |
9 6.5%
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14 10.1%
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23 8.3%
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White |
104 74.8%
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100 72.5%
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204 73.6%
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More than one race |
14 10.1%
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9 6.5%
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23 8.3%
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Unknown or Not Reported |
1 0.7%
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3 2.2%
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4 1.4%
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Region of Enrollment
Measure Type: Count of Participants Unit of measure: Participants |
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United States | Number Analyzed | 139 participants | 138 participants | 277 participants |
139 100.0%
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138 100.0%
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277 100.0%
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Aberrant Behavior Checklist Social Withdrawal Subscale Score (ABC-SW) abc-SW (mean
[1] Mean (Standard Deviation) Unit of measure: Units on a scale |
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Number Analyzed | 139 participants | 138 participants | 277 participants | |
11.0 (6.9) | 11.6 (7.8) | 11.3 (7.4) | ||
[1]
Measure Description: the Aberrant Behavior Scale Social withdrawal score assesses reciprocal social behaviors. It is composed of 13 questions from the Aberrant Behavior Scale Lethargy subscale that consists of 16 questions. The ABC-SW does not include the 3 questions (i.e. 3,32,53) of the Lethargy subscale that refer to sedentary behaviors. Score for each item ranges from 0 (not at all a problem) to 3 (a serious problem). Items are summed to give a minimal score of 0 and a maximal score of 39. Lower Scores are better
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Name/Title: | Linmarie Sikich, M.D. |
Organization: | Duke University |
Phone: | 919-681-0026 |
EMail: | linmarie.sikich@duke.edu |
Responsible Party: | Linmarie Sikich, Duke University |
ClinicalTrials.gov Identifier: | NCT01944046 |
Other Study ID Numbers: |
Pro00063950 1U01HD073984 ( U.S. NIH Grant/Contract ) 13-0593 ( Other Identifier: UNC ) |
First Submitted: | June 13, 2013 |
First Posted: | September 17, 2013 |
Results First Submitted: | July 31, 2020 |
Results First Posted: | January 5, 2021 |
Last Update Posted: | January 5, 2021 |