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Intranasal Oxytocin and Learning in Autism

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2014 by Children's Hospital of Philadelphia
Sponsor:
Information provided by (Responsible Party):
Robert Schultz, Children's Hospital of Philadelphia
ClinicalTrials.gov Identifier:
NCT01417026
First received: August 11, 2011
Last updated: April 2, 2014
Last verified: April 2014
  Purpose

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 Intervention Phase
Autism Spectrum Disorders
Drug: Intranasal Oxytocin (Trade name: Syntocinon)
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Promoting Social Perceptual Learning With Oxytocin in Autism

Resource links provided by NLM:


Further study details as provided by Children's Hospital of Philadelphia:

Primary Outcome Measures:
  • Change from Baseline to Post-testing (after max. 12 days) on the Part/Whole Identity Test (LFI Skills Battery) [ Time Frame: 12 days ] [ Designated as safety issue: No ]
    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).

  • Change from Baseline to Post-testing (after max. 12 days) on the Reading the Mind in the Eyes Test (Child version) [ Time Frame: 12 days ] [ Designated as safety issue: No ]
    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:
  • Changes from Baseline to Post-testing (after max. 12 days) on measures of social attention, reward/motivation, perception, and cognition [ Time Frame: 12 days ] [ Designated as safety issue: No ]
    Behavioral tasks: watching social interactions eye-tracking task, happy faces eye-tracking tasks, signal detection social task, discrimination task


Estimated Enrollment: 68
Study Start Date: September 2011
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   12 Years to 17 Years
Genders 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01417026

Contacts
Contact: Fottfam (Fam) Baguio, MS 1-866-570-6524 autism@email.chop.edu

Locations
United States, Pennsylvania
The Children's Hospital of Philadelphia Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Katrina Tennant    866-570-6524      
Sub-Investigator: Amanda Bennett, MD         
Sponsors and Collaborators
Robert Schultz
Investigators
Principal Investigator: Robert T. Schultz, PhD Center for Autism Research, The Children's Hospital of Philadelphia
  More Information

No publications provided

Responsible Party: Robert Schultz, Robert T. Schultz, PhD, Director of the Center for Autism Research, Children's Hospital of Philadelphia
ClinicalTrials.gov Identifier: NCT01417026     History of Changes
Other Study ID Numbers: 11-008241
Study First Received: August 11, 2011
Last Updated: April 2, 2014
Health Authority: United States: Institutional Review Board
United States: Food and Drug Administration

Keywords provided by 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
Child Development Disorders, Pervasive
Mental Disorders
Mental Disorders Diagnosed in Childhood
Oxytocin
Oxytocics
Pharmacologic Actions
Physiological Effects of Drugs
Reproductive Control Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on November 25, 2014