Trial · Interventional

CompletedPhase 2Results postedRegistry data

Intranasal Oxytocin and Learning in Autism

NCTNCT01417026Other id11-008241

Open at ClinicalTrials.govAsk about this trial

Overview

Status: Completed
Phase: Phase 2
Enrollment: 36 participants (actual)
Sponsor: Robert Schultz · Other
Design: Randomized · Quadruple masking
Countries: 1 country
United States
Start: Sept 2011
Primary completion: Apr 2015
Completion: Apr 2015
First posted: 16 Aug 2011 (estimated)
Last update posted: 30 Mar 2017
Conditions: Autism Spectrum Disorders

Timeline

1 trial · 1 completed · 1 with posted results

Completed
Ongoing
Not yet recruiting
Stopped
Estimated dates (est.)
Results posted

201120122013201420152016

Ph 2
Intranasal Oxytocin and Learning in Autism
NCT01417026
Sept 2011 to Apr 2015

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

Intranasal Oxytocin (Trade name: Syntocinon)Drug

Arms2

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.
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.

Primary outcomes2

Outcomes the sponsor listed as primary.

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)
Registry description
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.
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)
Registry description
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 outcomes(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)
Registry description
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.

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

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

Change From Baseline to Post-testing (After Max. 12 Days) on the Part/Whole Identity Test (LFI Skills Battery)

Group	Value (change in percent correct)	Spread
Intranasal Oxytocin	3.30	10.78
Intranasal Placebo	3.17	8.17

Primary outcomeMean· 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)

Group	Value (change in items correct)	Spread
Intranasal Oxytocin	0.33	3.92
Intranasal Placebo	1.82	3.34

Secondary and other outcome results(1)

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

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

Group	Value (change in proportion of looking)	Spread
Intranasal Oxytocin	.02	.18
Intranasal Placebo	-0.05	.25

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
Group	Deaths	Serious events	Other events
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. 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.	–	0 / 16	11 / 16
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. 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.	–	0 / 13	12 / 13

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex: Male
Age: from 12 Years up to 17 Years
Healthy volunteers: Not accepted

Inclusion and exclusion criteria, as posted

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.

PepBank is a research reference. Talk to a doctor before you use any peptide.