Intranasal Oxytocin and Learning in Autism

Robert Schultz

Status and phase: Completed; Phase 2

Conditions: Autism Spectrum Disorders

Treatments: Drug: Intranasal Oxytocin (Trade name: Syntocinon)

Study type: Interventional

Funder types: Other

Identifiers

NCT01417026

11-008241

Details and patient eligibility

About

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.

Full 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.

Enrollment: 36 patients

Sex: Male

Ages: 12 to 17 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

36 participants in 2 patient groups, including a placebo group

Intranasal Oxytocin

Active Comparator group

Description:

* 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.

Treatment:

Drug: Intranasal Oxytocin (Trade name: Syntocinon)

Intranasal Placebo

Placebo Comparator group

Description:

* 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.

Treatment:

Drug: Intranasal Oxytocin (Trade name: Syntocinon)