Intranasal Oxytocin and Learning in Autism

NCT01417026 | Completed Phase 2 Results DMC

• 1 other identifier: 11-008241
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

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.

Conditions

Autism Spectrum Disorders

Keywords

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

Outcome Measures

Primary Outcomes (2)

• 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.

  Baseline and Post-testing (after max. 12 days)

• 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.

  Baseline and Post-testing (after max. 12 days)

Secondary Outcomes (1)

• Changes From Baseline to Post-testing (After Max. 12 Days) on the "Happy Faces" Measure of Social Attention

  Baseline and Post-testing (after max. 12 days)

Study Arms (2)

Intranasal Oxytocin

ACTIVE COMPARATOR

* 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)

Intranasal Placebo

PLACEBO COMPARATOR

* 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)

Interventions

Intranasal Oxytocin (Trade name: Syntocinon) 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.

Also known as: Syntocinon

Intranasal Oxytocin; Intranasal Placebo

Eligibility Criteria

• Age: 12 Years - 17 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Participants aged 12-17 years, Mental age ≥ 10
• Gender: males
• Diagnosis of an Autism Spectrum Disorder
• Consent: parent/guardian permission and child assent.
• Ability to complete tasks: adequate vision, motor control of a keyboard and mouse, and fluency in English (and English as a first language).
• 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.

You may not qualify if:

• 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).
• 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.
• Sensory impairments (e.g., significant vision/hearing loss).
• Gestational age below 35 weeks and/or perinatal injury.
• Profound mental retardation (e.g., Intelligence quotient (IQ) \< 45) or sensory-motor difficulties that would preclude valid use of diagnostic instruments.
• Lack of impairment in face recognition as determined by average or above average performance on the Benton Face Recognition Task.
• Female participants.
• Patients who are sensitive to Syntocinon or any components of its formulation.
• Fever at the time of the baseline visit, defined as temperature above 37.5 degrees Celsius or 99.5 degrees Fahrenheit.
• Judgment by the study physician or the PI that the patient is not suitable for the study due to unforeseeable safety issues.

Sponsors & Collaborators

• Robert Schultz: lead

Study Sites (1)

The Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, 19104, United States

Location

MeSH Terms

Conditions

Autism Spectrum Disorder

Interventions

Oxytocin

Condition Hierarchy (Ancestors)

Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Pituitary Hormones, Posterior; Pituitary Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins

Results Point of Contact

• Title: Robert Schultz, PhD
• Organization: Children's Hospital of Philadelphia

schultzrt@email.chop.edu

267-426-7540

Study Officials

• Robert T. Schultz, PhD

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

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Robert T. Schultz, PhD, Director of the Center for Autism Research

Study Record Dates

• First Submitted: August 11, 2011
• First Posted: August 16, 2011
• Study Start: September 1, 2011
• Primary Completion: April 1, 2015
• Study Completion: April 1, 2015
• Last Updated: March 30, 2017
• Results First Posted: March 30, 2017

Record last verified: 2017-02

Locations

US (1)