- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01624194
Intranasal Oxytocin Treatment for Social Deficits in Children With Autism
Double-blind, Randomized, Placebo Controlled Trial of Intranasal Oxytocin Treatment for Social Deficits in Children With Autism.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
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California
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Stanford, California, United States, 94305
- Stanford University School of Medicine
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Medically healthy outpatients between 6 and 12 years of age (cut off 12 years and 11 months)
- Intelligence Quotient > 40
- Diagnosis of autism spectrum disorder based on the Autism Diagnostic Interview - Revised, Autism Diagnostic Observation Schedule, and DSM-IV criteria
- Clinical Global Impression severity rating of 4 or higher
- Care provider who can reliably bring subject to clinic visits, provide trustworthy ratings, and interacts with the subject on a regular basis
- Stable medications for at least 4 weeks
- No planned changes in psychosocial interventions during the trial
- Willingness to provide blood samples.
Exclusion Criteria:
- Diagnostics and Statistical Manual of Mental Disorders, 4th edition (DSM-IV) diagnosis of schizophrenia, schizoaffective disorder, or psychotic disorder
- Regular nasal obstruction or nosebleeds
- Active medical problems: unstable seizures, significant physical illness (e.g., serious liver, renal, or cardiac pathology)
- Sensitivity to preservatives (in particular E 216, E 218, and chlorobutanol hemihydrate)
- A genetic abnormality (e.g., Fragile X Syndrome)
- Significant hearing or vision impairments
- Habitually drinks large volumes of water
- Pregnancy, breastfeeding, or child birth within the last 6 months
- Sexually active females not using a reliable method of contraception.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
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.
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24IU BID (3 x 0.1 mL [4IU] sprays per nostril twice daily for 4-weeks.
Other Names:
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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.
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3 x 0.1 mL sprays per nostril twice daily for 4-weeks.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change From Baseline in Parent Rated Social Responsiveness Scale (SRS) Scores During Treatment.
Time Frame: Baseline; Week 4
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Social Responsiveness Scale (SRS) raw scores measure social abilities with lower raw scores meaning better social abilities.
(Raw Score Range: 0 - 195)
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Baseline; Week 4
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
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Dosage Record Treatment Emergent Symptom Scale (DOTES) side effects reported by parents during 4-weeks of treatment.
Participant Counts are used.
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Baseline through Week 4
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Change From Baseline in Height.
Time Frame: Baseline; Week 4
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Baseline; Week 4
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Clinical Global Impression-Improvement (CGI-I) Score at Week 4
Time Frame: Baseline to Week 4
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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.
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Baseline to Week 4
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Parent Rated Aberrant Behavior Checklist (ABC) Irritability Scores at Baseline and Week 4
Time Frame: Baseline; Week 4
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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.
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Baseline; Week 4
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Change From Baseline in Parent Rated Spence Children's Anxiety Scale (SCAS) During Treatment.
Time Frame: Baseline; Week 4
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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)
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Baseline; Week 4
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Change From Baseline in Vineland Adaptive Behavior Scales, Second Edition - Social and Communication Subscales During Treatment.
Time Frame: Baseline; Week 4
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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.
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Baseline; Week 4
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Change From Baseline in Laboratory Based Facial Emotion Recognition Abilities During Treatment.
Time Frame: Up to 4 weeks
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Up to 4 weeks
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Change From Baseline in Laboratory Based Eye-gaze to Social Cues During Treatment.
Time Frame: Baseline; Week 4
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Baseline; Week 4
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Change From Baseline in Reading the Mind in the Eyes Test, Child Version (RMET-child) Scores During Treatment.
Time Frame: Up to 4 weeks
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Up to 4 weeks
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Change From Baseline in Laboratory Based Social Mimicry Abilities During Treatment.
Time Frame: Up to 4 weeks
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Up to 4 weeks
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Change From Baseline in Developmental NEuroPSYchological Assessment (NEPSY-II) Affect Recognition Scores During Treatment.
Time Frame: Baseline; Week 4
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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. |
Baseline; Week 4
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Change From Baseline in Plasma Oxytocin Levels During Treatment.
Time Frame: Up to 4 weeks
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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. |
Up to 4 weeks
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Change From Baseline in Parent Rated Repetitive Behavior Scale- Revised (RBS-R) Scores During Treatment.
Time Frame: Baseline; Week 4
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Higher scores on the Repetitive Behavior Scale- Revised mean higher levels of repetitive and restricted behaviors.
(Raw Score Total Range: 0 - 129)
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Baseline; Week 4
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Change From Baseline in Weight
Time Frame: Baseline; Week 4
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Baseline; Week 4
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Change From Baseline in Heart Rate
Time Frame: Baseline; Week 4
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Baseline; Week 4
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Change From Baseline in Blood Pressure
Time Frame: Baseline; Week 4
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Baseline; Week 4
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Collaborators and Investigators
Sponsor
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- SU-12132011-8827
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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