Intranasal Oxytocin and Learning in Autism

Autism Spectrum Disorders Clinical Trial

Official title:

Promoting Social Perceptual Learning With Oxytocin in Autism

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01417026
• Other study ID #: 11-008241
• Status: Active, not recruiting
• Phase: Phase 2
• First received: August 11, 2011
• Last updated: September 16, 2015
• Start date: September 2011
• Est. completion date: April 2016

Study information

• Verified date: September 2015
• Source: Children's Hospital of Philadelphia
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review BoardUnited States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 36
• Est. completion date: April 2016
• Est. primary completion date: April 2015
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 12 Years to 17 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Autism Spectrum Disorders
• Autistic Disorder
• Child Development Disorders, Pervasive

Intervention

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.

Locations

Country	Name	City	State
United States	The Children's Hospital of Philadelphia	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Robert Schultz

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from Baseline to Post-testing (after max. 12 days) on the Part/Whole Identity Test (LFI Skills Battery)	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. Effect sizes ranged from a low 0.30 for the part mouth condition to a high of 0.81 for the whole eye condition, such that the condition measuring holistic processing in the eye region was most sensitive to group differences (ASD vs. TDC). This measure was also most sensitive to behavioral changes with the LFI intervention trial (Tanaka et al., 2010).	12 days	No
Primary	Change from Baseline to Post-testing (after max. 12 days) on the Reading the Mind in the Eyes Test (Child version)	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.	12 days	No
Secondary	Changes from Baseline to Post-testing (after max. 12 days) on measures of social attention, reward/motivation, perception, and cognition	Behavioral tasks: watching social interactions eye-tracking task, happy faces eye-tracking tasks, signal detection social task, discrimination task	12 days	No