Phase 2
Completed N=29
Intranasal Oxytocin and Learning in Autism
Source: ClinicalTrials.gov NCT01417026 ↗Enrolled (actual)
29
Serious AEs
0.0%
Results posted
Mar 2017
Primary outcomePrimary: Change From Baseline to Post-testing (After Max. 12 Days) on the Part/Whole Identity Test (LFI Skills Battery) — 3.30; 3.17 change in percent correct
Summary
The main objective of this study is to determine the safety and therapeutic potential of intranasal oxytocin in children and adolescents with autism spectrum disorder (ASD) when paired with a computer game intervention that is designed to enhance face perception skills.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline to Post-testing (After Max. 12 Days) on the Part/Whole Identity Test (LFI Skills Battery) |
3.30; 3.17 | — |
| PRIMARY Change From Baseline to Post-testing (After Max. 12 Days) on the Reading the Mind in the Eyes Test (Child Version) |
0.33; 1.82 | — |
| SECONDARY Changes From Baseline to Post-testing (After Max. 12 Days) on the "Happy Faces" Measure of Social Attention |
.02; -0.05; -.03; .08 | — |
Eligibility Criteria
Inclusion Criteria
- Participants aged 12-17 years, Mental age ≥ 10
- Gender: males
- Diagnosis of an Autism Spectrum Disorder
- Consent: parent/guardian permission and child assent.
- Ability to complete tasks: adequate vision, motor control of a keyboard and mouse, and fluency in English (and English as a first language).
- Study participant needs to be clinically stable, in the opinion of the study clinicians. Stability will be assessed by the clinicians based on information from and conversations with the parent, if necessary. The parent needs to commit verbally to not making any changes to his or her child's current treatments for the duration of this study.
Exclusion Criteria
- History of traumatic brain injury, epilepsy/seizure disorder (except febrile seizures), or other significant medical, genetic, or neurological abnormality affecting growth, development, or motor or higher cortical functioning. Sensory impairments (e.g., significant vision/hearing loss).
- Patients with one or more of the following: Human immunodeficiency virus (HIV), Hepatitis B Virus (HBV), Hepatitis C Virus (HCV), hemophilia (bleeding problems, recent nose and brain injuries), abnormal blood pressure (hypotension or hypertension), drug abuse, immunity disorder, or severe depression.
- Sensory impairments (e.g., significant vision/hearing loss).
- Gestational age below 35 weeks and/or perinatal injury.
- Profound mental retardation (e.g., Intelligence quotient (IQ) < 45) or sensory-motor difficulties that would preclude valid use of diagnostic instruments.
- Lack of impairment in face recognition as determined by average or above average performance on the Benton Face Recognition Task.
- Female participants.
- Patients who are sensitive to Syntocinon or any components of its formulation.
- Fever at the time of the baseline visit, defined as temperature above 37.5 degrees Celsius or 99.5 degrees Fahrenheit.
- Judgment by the study physician or the PI that the patient is not suitable for the study due to unforeseeable safety issues.
Data sourced from ClinicalTrials.gov (NCT01417026). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.