Overview

This trial is active, not recruiting.

Condition autism spectrum disorders
Treatment intranasal oxytocin (trade name: syntocinon)
Phase phase 2
Sponsor Robert Schultz
Start date September 2011
End date April 2015
Trial size 36 participants
Trial identifier NCT01417026, 11-008241

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose treatment
Arm
(Active Comparator)
Intranasal oxytocin (Trade name: Syntocinon) Pharmacological class: The pharmacologic and clinical properties of Syntocinon are identical with the naturally occurring hormone oxytocin, which is released from the posterior pituitary. Route of administration: Intranasal Planned exposure: Each participant will receive one dose of intranasal oxytocin (24 IU) per day for 5 days. One dose of 24 IU equals 6 spray puffs (3 puffs in each nostril). Oxytocin will be imported from Victoria Pharmacy Zurich- Switzerland.
intranasal oxytocin (trade name: syntocinon) Syntocinon
This is a double-blind placebo-controlled trial of intranasal oxytocin in children and adolescents with ASD. Subjects will be randomized to 24 IU intranasal oxytocin or placebo for a 5 day period with concomitant game play of computer games, which are designed to enhance face perception skills. Measures of social function and cognition will be administered before and after the intervention period.
(Placebo Comparator)
Intranasal placebo The placebo is identical to the oxytocin formulation with the exception of the active compound. Route of administration: Intranasal Planned exposure: Each participant will receive one dose of intranasal placebo per day for 5 days. One dose equals 6 spray puffs (3 puffs in each nostril). Placebo will be imported from Victoria Pharmacy Zurich- Switzerland.
intranasal oxytocin (trade name: syntocinon) Syntocinon
This is a double-blind placebo-controlled trial of intranasal oxytocin in children and adolescents with ASD. Subjects will be randomized to 24 IU intranasal oxytocin or placebo for a 5 day period with concomitant game play of computer games, which are designed to enhance face perception skills. Measures of social function and cognition will be administered before and after the intervention period.

Primary Outcomes

Measure
Change from Baseline to Post-testing (after max. 12 days) on the Part/Whole Identity Test (LFI Skills Battery)
time frame: 12 days
Change from Baseline to Post-testing (after max. 12 days) on the Reading the Mind in the Eyes Test (Child version)
time frame: 12 days

Secondary Outcomes

Measure
Changes from Baseline to Post-testing (after max. 12 days) on measures of social attention, reward/motivation, perception, and cognition
time frame: 12 days

Eligibility Criteria

Male participants from 12 years up to 17 years old.

Inclusion Criteria: 1. Participants aged 12-17 years, Mental age ≥ 10 2. Gender: males 3. Diagnosis of an Autism Spectrum Disorder 4. Consent: parent/guardian permission and child assent. 5. Ability to complete tasks: adequate vision, motor control of a keyboard and mouse, and fluency in English (and English as a first language). 6. 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: 1. 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). 2. 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. 3. Sensory impairments (e.g., significant vision/hearing loss). 4. Gestational age below 35 weeks and/or perinatal injury. 5. Profound mental retardation (e.g., Intelligence quotient (IQ) < 45) or sensory-motor difficulties that would preclude valid use of diagnostic instruments. 6. Lack of impairment in face recognition as determined by average or above average performance on the Benton Face Recognition Task. 7. Female participants. 8. Patients who are sensitive to Syntocinon or any components of its formulation. 9. Fever at the time of the baseline visit, defined as temperature above 37.5 degrees Celsius or 99.5 degrees Fahrenheit. 10. Judgment by the study physician or the PI that the patient is not suitable for the study due to unforeseeable safety issues.

Additional Information

Official title Promoting Social Perceptual Learning With Oxytocin in Autism
Principal investigator Robert T. Schultz, PhD
Description Recognizing faces is critical to social functioning, and can be improved for individuals with ASD by using intervention software in the form of appropriately designed computer games. The effects of this type of social intervention may be amplified with the concurrent use of oxytocin. Furthermore, these learning effects may impact social skills in general and translate to the level of the individual's everyday social behavior. Thus, the objective of this study is to determine the safety and therapeutic potential of intranasal oxytocin in children and adolescents with ASD when paired with a computer game intervention that is designed to enhance face perception skills.
Trial information was received from ClinicalTrials.gov and was last updated in September 2015.
Information provided to ClinicalTrials.gov by Children's Hospital of Philadelphia.