Intranasal Oxytocin Treatment for Social Deficits in Children With Autism
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|ClinicalTrials.gov Identifier: NCT01624194|
Recruitment Status : Completed
First Posted : June 20, 2012
Results First Posted : June 6, 2018
Last Update Posted : July 15, 2019
|Condition or disease||Intervention/treatment||Phase|
|Autism||Drug: Oxytocin nasal spray Drug: Placebo||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||54 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Double-blind, Randomized, Placebo Controlled Trial of Intranasal Oxytocin Treatment for Social Deficits in Children With Autism.|
|Actual Study Start Date :||June 2012|
|Actual Primary Completion Date :||May 2016|
|Actual Study Completion Date :||May 2016|
Active Comparator: Oxytocin nasal spray
Prior to randomization, all subjects will participate in a 1-week open-label placebo lead-in trial. Each subject will be administered the placebo nasal spray at Stanford University and then their parent will continue administering the nasal spray to the subject for 1 week at home. Each subject will then be randomly assigned either to the active group or to the placebo (stratified by gender) and will be given the appropriate nasal spray bottle and their parents will be responsible for administering 3 puffs per nostril (4 IU/puff) to their child for a total dose of 24 IU oxytocin or placebo twice daily (BID; morning and evening) for 4-weeks. On completion of this 4-week treatment trial subjects will have the option of participating in a second double-blind trial in which they will be assigned to the alternate nasal spray, to that which they received during the first 4-week trial, for an additional 4-week period.
Drug: Oxytocin nasal spray
24IU BID (3 x 0.1 mL [4IU] sprays per nostril twice daily for 4-weeks.
Other Name: Syntocinon® Nasal Spray
Placebo Comparator: Placebo nasal spray
The placebo nasal spray bottles will be prepared by adding all of the ingredients used in the Syntocinon nasal sprays with the exception of the concentrated oxytocin solution.
3 x 0.1 mL sprays per nostril twice daily for 4-weeks.
- Change From Baseline in Parent Rated Social Responsiveness Scale (SRS) Scores During Treatment. [ Time Frame: Baseline; Week 4 ]Social Responsiveness Scale (SRS) raw scores measure social abilities with lower raw scores meaning better social abilities. (Raw Score Range: 0 - 195)
- Number of Participants With Side Effects Assessed Using Parent Rated Dosage Record Treatment Emergent Symptom Scale (DOTES) Scores During Treatment [ Time Frame: Baseline through Week 4 ]Dosage Record Treatment Emergent Symptom Scale (DOTES) side effects reported by parents during 4-weeks of treatment. Participant Counts are used.
- Change From Baseline in Height. [ Time Frame: Baseline; Week 4 ]
- Clinical Global Impression-Improvement (CGI-I) Score at Week 4 [ Time Frame: Baseline to Week 4 ]This outcome is reported as the count of participants in each CGI-I rating category at the week 4 visit, assessing change over the 4-week period. CGI-I rating of 1=Very Much Improved, 2=Much Improved, 3=Minimally Improved, 4=No Change, 5=Minimally Worse, 6=Much Worse, and 7=Very Much Worse.
- Parent Rated Aberrant Behavior Checklist (ABC) Irritability Scores at Baseline and Week 4 [ Time Frame: Baseline; Week 4 ]Higher scores indicate more symptoms, lower scores indicate fewer symptoms. Irritability scores can range from 0-45. Lethargy scores can range from 0-48. Stereotypy scores can range from 0-21. Hyperactivity scores can range from 0-48. Inappropriate speech scores can from 0-12.
- Change From Baseline in Parent Rated Spence Children's Anxiety Scale (SCAS) During Treatment. [ Time Frame: Baseline; Week 4 ]Scale measuring severity of anxiety symptoms. Higher scores mean higher levels of anxiety, lower scores mean lower levels of anxiety. (Raw Score Range: 0 - 114)
- Change From Baseline in Vineland Adaptive Behavior Scales, Second Edition - Social and Communication Subscales During Treatment. [ Time Frame: Baseline; Week 4 ]Higher Social Standard Score means better social skills, lower Social Standard Score means worse social skills. Higher Communication Standard Score means better communication skills, lower Communication Standard Score means worse communication skills. Standard Scores can range from 20 to 160.
- Change From Baseline in Laboratory Based Facial Emotion Recognition Abilities During Treatment. [ Time Frame: Up to 4 weeks ]
- Change From Baseline in Laboratory Based Eye-gaze to Social Cues During Treatment. [ Time Frame: Baseline; Week 4 ]
- Change From Baseline in Reading the Mind in the Eyes Test, Child Version (RMET-child) Scores During Treatment. [ Time Frame: Up to 4 weeks ]
- Change From Baseline in Laboratory Based Social Mimicry Abilities During Treatment. [ Time Frame: Up to 4 weeks ]
- Change From Baseline in Developmental NEuroPSYchological Assessment (NEPSY-II) Affect Recognition Scores During Treatment. [ Time Frame: Baseline; Week 4 ]
Higher Affect Recognition scores mean better affect recognition abilities, lower Affect Recognition scores mean worse affect recognition abilities.
Scores can range from 1 to 19.
- Change From Baseline in Plasma Oxytocin Levels During Treatment. [ Time Frame: Up to 4 weeks ]
This outcome originally specified that oxytocin, vasopressin, and cortisol levels would be assessed; however, data on vasopressin and cortisol levels were not collected during the study.
There are no clinical laboratory tests that establish a normative range for oxytocin. Measurements prior to and following treatment were intended to evaluate oxytocin level as a predictor of response.
- Change From Baseline in Parent Rated Repetitive Behavior Scale- Revised (RBS-R) Scores During Treatment. [ Time Frame: Baseline; Week 4 ]Higher scores on the Repetitive Behavior Scale- Revised mean higher levels of repetitive and restricted behaviors. (Raw Score Total Range: 0 - 129)
- Change From Baseline in Weight [ Time Frame: Baseline; Week 4 ]
- Change From Baseline in Heart Rate [ Time Frame: Baseline; Week 4 ]
- Change From Baseline in Blood Pressure [ Time Frame: Baseline; Week 4 ]
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): NCT01624194
|United States, California|
|Stanford University School of Medicine|
|Stanford, California, United States, 94305|
|Principal Investigator:||Antonio Y Hardan, MD||Stanford University|
|Principal Investigator:||Karen J Parker, PhD||Stanford University|