Overview

This trial is active, not recruiting.

Condition autism spectrum disorders
Treatments syntocinon (synthetic oxytocin), placebo
Phase phase 2
Sponsor University of Minnesota - Clinical and Translational Science Institute
Collaborator Children's Hospital of Philadelphia
Start date March 2014
End date May 2016
Trial size 52 participants
Trial identifier NCT02090829, FaceStation

Summary

: The objective of this study is to determine the tolerability and therapeutic potential of oxytocin in children and adolescents with Autism Spectrum Disorders (ASD) when paired with a computer game intervention that is designed to enhance face perception skills. We designate two measures as our primary outcomes, based on prior published work with these interventions, and we propose a sample based on power analyses from these prior results. A second objective of this study is to learn about the breadth of possible positive effects that this combination therapy might have for children with ASD. To this end, we include a host of other exploratory measures that assess aspects of social motivation and attention, social perception, and social cognition. Thus, a second objective is to conduct a "signal finding" study - to gather outcome data on a range of dependent variables that theoretically should be related to oxytocin's effects on social processes, but for which there are no prior data. The signal finding aspect of this study will provide the preliminary data needed to design a more targeted follow up study.

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)
Primary purpose treatment
Arm
(Placebo Comparator)
Placebo Comparator: Intranasal Placebo 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
Placebo Comparator: Intranasal Placebo 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).
(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.
syntocinon (synthetic oxytocin) Syntocinon
Syntocinon is a nine residue cyclic peptide; the hormone is prepared synthetically to avoid possible contamination with vasopressin and other small polypeptides with biologic activity.

Primary Outcomes

Measure
Change from Baseline to Post-testing on the The Part/Whole Identity Test
time frame: Baseline/Follow-up post testing (max 12 days)
Change from Baseline to Post-testing on the Reading the Mind in the Eyes Task
time frame: Baseline to Post-testing (max. 12 days)

Secondary Outcomes

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

Eligibility Criteria

Male participants from 12 years up to 17 years old.

Inclusion Criteria: 1. Subjects aged 12-17 years, Mental age ≥ 7 (as measured by an IQ test such as the Differential Ability Scales II). 2. Gender: males 3. Diagnosis of an ASD 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 6. Study participant needs to be on 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 acquired neurological abnormality affecting brain function and motor, sensory or higher cognitive functioning. 2. Patients with one or more of the following: HIV, HBV, 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., 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/P.I. (Suma Jacob, M.D,) 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 Suma Jacob, M.D. Ph.D
Description This is a double-blind placebo-controlled trial of intranasal oxytocin in 52 children and adolescents with ASD. Diagnosis will be confirmed using Diagnostic and Statistical Manual (DSM) criteria, supported by the Autism Diagnostic Interview and the Autism Diagnostic Observation Schedule. Subjects will be randomized to 24 IU intranasal oxytocin or placebo for a 5 day period with concomitant game play of the FaceStation computer games, developed at CHOP. Measures of social function and cognition will be administered before and after the game play period. Two measures of social functioning will serve as our primary endpoints; all other measures will be treated as exploratory variables, with significance testing corrected for multiple comparisons. 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 August 2016.
Information provided to ClinicalTrials.gov by University of Minnesota - Clinical and Translational Science Institute.