Intranasal Oxytocin and Learning in Autism

NCT02090829 | Withdrawn Phase 2 DMC

• 1 other identifier: 1402M48250
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

: The objective of this study is to determine the tolerability and therapeutic potential of oxytocin in children and adolescents with Autism Spectrum Disorders (ASD) when paired with a computer game intervention that is designed to enhance face perception skills. We designate two measures as our primary outcomes, based on prior published work with these interventions, and we propose a sample based on power analyses from these prior results. A second objective of this study is to learn about the breadth of possible positive effects that this combination therapy might have for children with ASD. To this end, we include a host of other exploratory measures that assess aspects of social motivation and attention, social perception, and social cognition. Thus, a second objective is to conduct a "signal finding" study - to gather outcome data on a range of dependent variables that theoretically should be related to oxytocin's effects on social processes, but for which there are no prior data. The signal finding aspect of this study will provide the preliminary data needed to design a more targeted follow up study.

Conditions

Autism Spectrum Disorders

Keywords

Autism; Oxytocin; Syntocinon

Outcome Measures

Primary Outcomes (2)

• Change from Baseline to Post-testing on the The Part/Whole Identity Test

  4\) Part/Whole Identity Test measures the extent to which the participant employed a featural or holistic face recognition strategy. In this task, a sample face is presented for 4 sec, followed by a test face composed of either two whole faces or two face parts. As expected in Part/Whole Identity, 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. This measure was also most sensitive to behavioral changes with the LFI intervention trial.

  Baseline/Follow-up post testing (max 12 days)

• Change from Baseline to Post-testing on the Reading the Mind in the Eyes Task

  Reading the Mind in the Eyes Test (child version) (Baron-Cohen, et al., 2001) 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 to Post-testing (max. 12 days)

Secondary Outcomes (1)

• Change from Baseline to Post-testing on measures of social attention, reward/motivation, perception and cognition

  Baseline/follow-up (after max 12 days)

Study Arms (2)

Placebo Group

PLACEBO COMPARATOR

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).

Other: Placebo

Experimental Group

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: Syntocinon (synthetic oxytocin)

Interventions

Syntocinon (synthetic oxytocin) DRUG

Syntocinon is a nine residue cyclic peptide; the hormone is prepared synthetically to avoid possible contamination with vasopressin and other small polypeptides with biologic activity.

Also known as: Syntocinon

Experimental Group

Placebo OTHER

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 Group

Eligibility Criteria

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

You may qualify if:

• Subjects aged 12-17 years, Mental age ≥ 7 (as measured by an IQ test such as the Differential Ability Scales II).
• Gender: males
• Diagnosis of an ASD
• Consent: parent/guardian permission and child assent.
• Ability to complete tasks: adequate vision, motor control of a keyboard and mouse, and fluency in English
• Study participant needs to be on 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 acquired neurological abnormality affecting brain function and motor, sensory or higher cognitive functioning.
• Patients with one or more of the following: HIV, HBV, 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., 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/P.I. (Suma Jacob, M.D,) that the patient is not suitable for the study due to unforeseeable safety issues.

Sponsors & Collaborators

• University of Minnesota: lead
• Children's Hospital of Philadelphia: collaborator

Study Sites (1)

Center for Neurobehavioral Development

Minneapolis, Minnesota, 55414, United States

Location

MeSH Terms

Conditions

Autism Spectrum Disorder; Autistic 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

Study Officials

• Suma Jacob, M.D. Ph.D

  University of Minnesota Department of Psychiatry

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 28, 2014
• First Posted: March 18, 2014
• Study Start: March 1, 2014
• Primary Completion: March 1, 2018
• Study Completion: March 1, 2018
• Last Updated: November 1, 2019

Record last verified: 2019-10

Locations

US (1)