Intranasal Oxytocin and Learning in Autism

NCT ID: NCT01417026

Last Updated: 2017-03-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 36 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-09-30
• Study Completion Date: 2015-04-30

Brief 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.

Detailed 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.

Conditions

Autism Spectrum Disorders

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Intranasal Oxytocin

• 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.

Group Type: ACTIVE_COMPARATOR

Intranasal Oxytocin (Trade name: Syntocinon)

Intervention Type: DRUG

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.

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 will be imported from Victoria Pharmacy Zurich- Switzerland.

Group Type: PLACEBO_COMPARATOR

Intranasal Oxytocin (Trade name: Syntocinon)

Intervention Type: DRUG

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.

Interventions

Intranasal Oxytocin (Trade name: 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.

Intervention Type: DRUG

Other Intervention Names

Syntocinon

Eligibility Criteria

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.

• Minimum Eligible Age: 12 Years
• Maximum Eligible Age: 17 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Robert Schultz

OTHER

Sponsor Role: lead

Responsible Party

Robert Schultz

Robert T. Schultz, PhD, Director of the Center for Autism Research

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Robert T. Schultz, PhD

Role: PRINCIPAL_INVESTIGATOR

Center for Autism Research, The Children's Hospital of Philadelphia

Locations

The Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, United States

Countries

United States

Other Identifiers

11-008241

Identifier Type: -

Identifier Source: org_study_id