Trial Outcomes & Findings for Intranasal Oxytocin and Learning in Autism (NCT NCT01417026)
NCT ID: NCT01417026
Last Updated: 2017-03-30
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
36 participants
Primary outcome timeframe
Baseline and Post-testing (after max. 12 days)
Results posted on
2017-03-30
Participant Flow
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.
Participant milestones
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
STARTED
|
16
|
13
|
|
Overall Study
COMPLETED
|
14
|
13
|
|
Overall Study
NOT COMPLETED
|
2
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Intranasal Oxytocin and Learning in Autism
Baseline characteristics by cohort
| Measure |
Intranasal Oxytocin
n=14 Participants
* 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
n=13 Participants
* 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
n=27 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
14 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
27 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
14 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
27 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
14 participants
n=5 Participants
|
13 participants
n=7 Participants
|
27 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Intranasal Oxytocin
n=14 Participants
* 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
n=13 Participants
* 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.
|
|---|---|---|
|
Change From Baseline to Post-testing (After Max. 12 Days) on the Part/Whole Identity Test (LFI Skills Battery)
|
3.30 change in percent correct
Standard Deviation 10.78
|
3.17 change in percent correct
Standard Deviation 8.17
|
PRIMARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Intranasal Oxytocin
n=12 Participants
* 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
n=11 Participants
* 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.
|
|---|---|---|
|
Change From Baseline to Post-testing (After Max. 12 Days) on the Reading the Mind in the Eyes Test (Child Version)
|
0.33 change in items correct
Standard Deviation 3.92
|
1.82 change in items correct
Standard Deviation 3.34
|
SECONDARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Intranasal Oxytocin
n=8 Participants
* 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
n=9 Participants
* 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.
|
|---|---|---|
|
Changes From Baseline to Post-testing (After Max. 12 Days) on the "Happy Faces" Measure of Social Attention
looking to faces relative to full screen
|
.02 change in proportion of looking
Standard Deviation .18
|
-0.05 change in proportion of looking
Standard Deviation .25
|
|
Changes From Baseline to Post-testing (After Max. 12 Days) on the "Happy Faces" Measure of Social Attention
looking to objects relative to full screen
|
-.03 change in proportion of looking
Standard Deviation .14
|
.08 change in proportion of looking
Standard Deviation .18
|
Adverse Events
Intranasal Oxytocin
Serious events: 0 serious events
Other events: 11 other events
Deaths: 0 deaths
Intranasal Placebo
Serious events: 0 serious events
Other events: 12 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Intranasal Oxytocin
n=16 participants at risk
* 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
n=13 participants at risk
* 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.
|
|---|---|---|
|
Gastrointestinal disorders
Diarrhea, soft bowels, sore stomach
|
6.2%
1/16 • 12 Days
|
7.7%
1/13 • 12 Days
|
|
General disorders
Cold-like symptoms (i.e. runny nose, stuffy nose, sneezing)
|
37.5%
6/16 • 12 Days
|
23.1%
3/13 • 12 Days
|
|
Respiratory, thoracic and mediastinal disorders
Burning and irritation of sinuses
|
6.2%
1/16 • 12 Days
|
7.7%
1/13 • 12 Days
|
|
Respiratory, thoracic and mediastinal disorders
Bloody nose
|
6.2%
1/16 • 12 Days
|
0.00%
0/13 • 12 Days
|
|
Respiratory, thoracic and mediastinal disorders
Increased sense of smell
|
0.00%
0/16 • 12 Days
|
15.4%
2/13 • 12 Days
|
|
Respiratory, thoracic and mediastinal disorders
Sore throat
|
12.5%
2/16 • 12 Days
|
0.00%
0/13 • 12 Days
|
|
Ear and labyrinth disorders
Ear aches/hot ears
|
0.00%
0/16 • 12 Days
|
15.4%
2/13 • 12 Days
|
|
Respiratory, thoracic and mediastinal disorders
Breathing problems
|
0.00%
0/16 • 12 Days
|
7.7%
1/13 • 12 Days
|
|
Eye disorders
Eyes (burning, watery, teary, aching, etc.)
|
18.8%
3/16 • 12 Days
|
15.4%
2/13 • 12 Days
|
|
Nervous system disorders
Headaches
|
0.00%
0/16 • 12 Days
|
30.8%
4/13 • 12 Days
|
|
Cardiac disorders
Rapid pounding heart
|
6.2%
1/16 • 12 Days
|
0.00%
0/13 • 12 Days
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
6.2%
1/16 • 12 Days
|
0.00%
0/13 • 12 Days
|
|
Gastrointestinal disorders
Tongue ulcer and gum pain
|
0.00%
0/16 • 12 Days
|
7.7%
1/13 • 12 Days
|
|
Skin and subcutaneous tissue disorders
Flaking scalp
|
6.2%
1/16 • 12 Days
|
0.00%
0/13 • 12 Days
|
|
Psychiatric disorders
Frustration, cranky, agitation
|
25.0%
4/16 • 12 Days
|
23.1%
3/13 • 12 Days
|
|
Psychiatric disorders
Tired, Exhausted, Fatigued, decreased energy level, felt sedated
|
25.0%
4/16 • 12 Days
|
7.7%
1/13 • 12 Days
|
|
Psychiatric disorders
Increased energy level, hyperactivity
|
6.2%
1/16 • 12 Days
|
7.7%
1/13 • 12 Days
|
|
Psychiatric disorders
Nervous feeling
|
6.2%
1/16 • 12 Days
|
7.7%
1/13 • 12 Days
|
|
Psychiatric disorders
Increased awareness and social interaction
|
6.2%
1/16 • 12 Days
|
7.7%
1/13 • 12 Days
|
|
Psychiatric disorders
Increased appetite
|
6.2%
1/16 • 12 Days
|
0.00%
0/13 • 12 Days
|
|
Psychiatric disorders
Hand wringing
|
0.00%
0/16 • 12 Days
|
7.7%
1/13 • 12 Days
|
|
Psychiatric disorders
Sleep problems
|
0.00%
0/16 • 12 Days
|
7.7%
1/13 • 12 Days
|
|
Psychiatric disorders
Strange physical feelings
|
6.2%
1/16 • 12 Days
|
0.00%
0/13 • 12 Days
|
Additional Information
Robert Schultz, PhD
Children's Hospital of Philadelphia
Phone: 267-426-7540
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place