Intranasal Oxytocin and Learning in Autism

• Sponsor: Robert Schultz (Other)
• Overall Status: Completed
• CT.gov ID: NCT01417026
• Collaborator: (none)
• Enrollment: 36
• Location: 1
• Arms: 2
• Duration (Months): 43
• Patients Per Site Per Month: 0.8

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Autism Spectrum Disorders	Drug: Intranasal Oxytocin (Trade name: Syntocinon)	Phase 2

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 36 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Promoting Social Perceptual Learning With Oxytocin in Autism
• Study Start Date: Sep 1, 2011
• Actual Primary Completion Date: Apr 1, 2015
• Actual Study Completion Date: Apr 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
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 Names: 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 Names: Syntocinon

Outcome Measures

Primary Outcome Measures

1. Change From Baseline to Post-testing (After Max. 12 Days) on the Part/Whole Identity Test (LFI Skills Battery) [Baseline and Post-testing (after max. 12 days)]

   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.

2. Change From Baseline to Post-testing (After Max. 12 Days) on the Reading the Mind in the Eyes Test (Child Version) [Baseline and Post-testing (after max. 12 days)]

   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

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)]

   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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 12 Years to 17 Years
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	The Children's Hospital of Philadelphia	Philadelphia	Pennsylvania	United States	19104

Sponsors and Collaborators

• Robert Schultz

Investigators

• Principal Investigator: Robert T. Schultz, PhD, Center for Autism Research, The Children's Hospital of Philadelphia

Study Documents (Full-Text)

None provided.

More Information

Publications

None 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
• Other Study ID Numbers: 11-008241
• First Posted: Aug 16, 2011
• Last Update Posted: Mar 30, 2017
• Last Verified: Feb 1, 2017

• Keywords provided by Robert Schultz, Robert T. Schultz, PhD, Director of the Center for Autism Research, 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; Autism Spectrum Disorder; Oxytocin

Study Results

Participant Flow

Pre-assignment Detail	The number of enrolled participants in the study was 36, but only 29 of those subjects were randomized. The 7 subjects who were not randomized did not meet study diagnostic or cognitive inclusion criteria.

Arm/Group Title	Intranasal Oxytocin	Intranasal Placebo
Arm/Group Description	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.	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.
Period Title: Overall Study
STARTED	16	13
COMPLETED	14	13
NOT COMPLETED	2	0

Baseline Characteristics

Arm/Group Title	Intranasal Oxytocin	Intranasal Placebo	Total
Arm/Group Description	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.	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.	Total of all reporting groups
Overall Participants	14	13	27
Age (Count of Participants)
<=18 years	14 100%	13 100%	27 100%
Between 18 and 65 years	0 0%	0 0%	0 0%
>=65 years	0 0%	0 0%	0 0%
Sex: Female, Male (Count of Participants)
Female	0 0%	0 0%	0 0%
Male	14 100%	13 100%	27 100%
Region of Enrollment (participants) [Number]
United States	14 100%	13 100%	27 100%

Outcome Measures

1. Primary Outcome

Title	Change From Baseline to Post-testing (After Max. 12 Days) on the Part/Whole Identity Test (LFI Skills Battery)
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.
Time Frame	Baseline and Post-testing (after max. 12 days)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Intranasal Oxytocin	Intranasal Placebo
Arm/Group Description	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.	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.
Measure Participants	14	13
Mean (Standard Deviation) [change in percent correct]	3.30 (10.78)	3.17 (8.17)

2. Primary Outcome

Title	Change From Baseline to Post-testing (After Max. 12 Days) on the Reading the Mind in the Eyes Test (Child Version)
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.
Time Frame	Baseline and Post-testing (after max. 12 days)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Intranasal Oxytocin	Intranasal Placebo
Arm/Group Description	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.	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.
Measure Participants	12	11
Mean (Standard Deviation) [change in items correct]	0.33 (3.92)	1.82 (3.34)

3. Secondary Outcome

Title	Changes From Baseline to Post-testing (After Max. 12 Days) on the "Happy Faces" Measure of Social Attention
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.
Time Frame	Baseline and Post-testing (after max. 12 days)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Intranasal Oxytocin	Intranasal Placebo
Arm/Group Description	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.	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.
Measure Participants	8	9
looking to faces relative to full screen	.02 (.18)	-0.05 (.25)
looking to objects relative to full screen	-.03 (.14)	.08 (.18)

Adverse Events

Time Frame	12 Days
Arm/Group Title	Intranasal Oxytocin		Intranasal Placebo
Arm/Group Description	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.		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.
All Cause Mortality
	Intranasal Oxytocin		Intranasal Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Intranasal Oxytocin		Intranasal Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/16 (0%)		0/13 (0%)
Other (Not Including Serious) Adverse Events
	Intranasal Oxytocin		Intranasal Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	11/16 (68.8%)		12/13 (92.3%)
Cardiac disorders
Rapid pounding heart	1/16 (6.3%)		0/13 (0%)
Ear and labyrinth disorders
Ear aches/hot ears	0/16 (0%)		2/13 (15.4%)
Eye disorders
Eyes (burning, watery, teary, aching, etc.)	3/16 (18.8%)		2/13 (15.4%)
Gastrointestinal disorders
Diarrhea, soft bowels, sore stomach	1/16 (6.3%)		1/13 (7.7%)
Tongue ulcer and gum pain	0/16 (0%)		1/13 (7.7%)
General disorders
Cold-like symptoms (i.e. runny nose, stuffy nose, sneezing)	6/16 (37.5%)		3/13 (23.1%)
Musculoskeletal and connective tissue disorders
Back pain	1/16 (6.3%)		0/13 (0%)
Nervous system disorders
Headaches	0/16 (0%)		4/13 (30.8%)
Psychiatric disorders
Frustration, cranky, agitation	4/16 (25%)		3/13 (23.1%)
Tired, Exhausted, Fatigued, decreased energy level, felt sedated	4/16 (25%)		1/13 (7.7%)
Increased energy level, hyperactivity	1/16 (6.3%)		1/13 (7.7%)
Nervous feeling	1/16 (6.3%)		1/13 (7.7%)
Increased awareness and social interaction	1/16 (6.3%)		1/13 (7.7%)
Increased appetite	1/16 (6.3%)		0/13 (0%)
Hand wringing	0/16 (0%)		1/13 (7.7%)
Sleep problems	0/16 (0%)		1/13 (7.7%)
Strange physical feelings	1/16 (6.3%)		0/13 (0%)
Respiratory, thoracic and mediastinal disorders
Burning and irritation of sinuses	1/16 (6.3%)		1/13 (7.7%)
Bloody nose	1/16 (6.3%)		0/13 (0%)
Increased sense of smell	0/16 (0%)		2/13 (15.4%)
Sore throat	2/16 (12.5%)		0/13 (0%)
Breathing problems	0/16 (0%)		1/13 (7.7%)
Skin and subcutaneous tissue disorders
Flaking scalp	1/16 (6.3%)		0/13 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.