Intranasal Oxytocin and Learning in Autism

• ClinicalTrials.gov Identifier: NCT01417026
• Recruitment Status: Completed
• First Posted: August 16, 2011
• Results First Posted: March 30, 2017
• Last Update Posted: March 30, 2017
• Sponsor: Robert Schultz
• Information provided by (Responsible Party): Robert Schultz, Children's Hospital of Philadelphia

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Autism Spectrum Disorders	Drug: Intranasal Oxytocin (Trade name: Syntocinon)	Phase 2

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 36 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Promoting Social Perceptual Learning With Oxytocin in Autism
• Study Start Date: September 2011
• Actual Primary Completion Date: April 2015
• Actual Study Completion Date: April 2015

Arms and Interventions

Arm	Intervention/treatment
Active Comparator: 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.	Drug: 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.; Other Name: Syntocinon
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 will be imported from Victoria Pharmacy Zurich- Switzerland.	Drug: 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.; Other Name: Syntocinon

Outcome Measures

Primary Outcome Measures :

1. Change From Baseline to Post-testing (After Max. 12 Days) on the Part/Whole Identity Test (LFI Skills Battery) [ Time Frame: Baseline and Post-testing (after max. 12 days) ]
   This test measures the extent to which the participant employed a featural or holistic face recognition strategy. A sample face is presented, followed by a test face composed of either two whole faces or two face parts.
2. Change From Baseline to Post-testing (After Max. 12 Days) on the Reading the Mind in the Eyes Test (Child Version) [ Time Frame: Baseline and Post-testing (after max. 12 days) ]
   This is a test of emotion recognition. This test asks children to pick the best word out of four options to describe the mental state of a set of eyes. The test includes 28 photographs of eyes with both affective (e.g., upset) and cognitive (e.g., thoughtful) mental state words as choices.

Secondary Outcome Measures :

1. Changes From Baseline to Post-testing (After Max. 12 Days) on the "Happy Faces" Measure of Social Attention [ Time Frame: Baseline and Post-testing (after max. 12 days) ]
   The "Happy Faces" task requires that participants look at a series of faces of men and women. Faces are presented on the screen one by one and children are asked just to look at the faces. Eye movements are measured with a Tobii x120 tabletop eye-tracker to evaluate participants' looking patterns towards the eyes versus the mouth region.

Eligibility Criteria

• Ages Eligible for Study: 12 Years to 17 Years (Child)
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

United States, Pennsylvania

The Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, United States, 19104

Sponsors and Collaborators

Robert Schultz

Investigators

• Principal Investigator: Robert T. Schultz, PhD; Center for Autism Research, The Children's Hospital of Philadelphia

More Information

• Responsible Party: Robert Schultz, Robert T. Schultz, PhD, Director of the Center for Autism Research, Children's Hospital of Philadelphia
• ClinicalTrials.gov Identifier: NCT01417026
• Other Study ID Numbers: 11-008241
• First Posted: August 16, 2011
• Results First Posted: March 30, 2017
• Last Update Posted: March 30, 2017
• Last Verified: February 2017

Keywords provided by Robert Schultz, Children's Hospital of Philadelphia:

Autism Spectrum Disorders; Oxytocin; Clinical Trial; Computer-based Intervention; Social Perception; Social Motivation; Social Cognition

Additional relevant MeSH terms:

Autistic Disorder; Autism Spectrum Disorder; Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders; Oxytocin; Oxytocics; Reproductive Control Agents; Physiological Effects of Drugs