Trial · NCT01308749
A Study of Oxytocin in Children and Adolescents With Autistic Disorder
NCT01308749, Phase 2, Completed, University of North Carolina, Chapel Hill; results first posted 2017-07-17
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Study of Oxytocin in Children and Adolescents With Autistic Disorder. Trials, record NCT01308749. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01308749
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study of Oxytocin in Children and Adolescents With Autistic Disorder
- NCT number
- NCT01308749
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 25 participants, actual
- Lead sponsor
- University of North Carolina, Chapel Hill
- Conditions
- Autism
- Interventions
- Oxytocin, Placebo
- First posted
- 2011-03-04
- Last updated
- 2017-07-17
- Results first posted
- 2017-07-17
- Limitations and caveats
This was a very small study with a very heterogeneous sample. Further the two groups included very different proportions of intellectually disabled non-verbal participants which may influence assessment of benefit.
Source ClinicalTrials.gov
Registered outcomes11
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants Who Could Tolerate Twice Daily Oxytocin | Week 0 to week 8 | This study will help to determine tolerability of intranasal oxytocin treatment in children with autism by measuring the ability of at least 80% of the sample to tolerate twice daily intranasal administration of oxytocin. |
| Primary | Number of Participants Who Could Tolerate Twice Daily Oxytocin | Week 0 to week 16 | This study will help to determine tolerability of intranasal oxytocin treatment in children with autism by measuring the ability of at least 80% of the sample to tolerate twice daily intranasal administration of oxytocin. |
| Secondary | Change in Mean Plasma Oxytocin Level During Period 1 - Double Blind Phase | Week 0 to week 8 | Blood samples will be collected to obtain proof of concept data regarding changes in afternoon plasma oxytocin levels |
| Secondary | Change in Mean Weight | between weeks 0 and 8 | changes during period 1 |
| Secondary | Change in Mean Total Social Social Responsiveness Scale (SRS) T-score | 0-8 weeks, blinded treatment, period 1 | The 65-item SRS is a standardized measure of the core symptoms of autism. Each item is scored on a 4-point Likert scale. The raw score of each individual item is summed to create a total raw score. The total raw score is then translated into a total T-scores (which are the equivalent of standard scores). Total T-scores results are as follows: 59 and below: within normal limits, 60-65: Mild range of impairment 66-75: Moderate range of impairment 76 or higher: Severe range of impairment. |
| Secondary | Change in Mean Autism Diagnostic Observation Schedule (ADOS) Total Score | Baseline to 16 Weeks | The ADOS is a semi-structured assessment used to assess and diagnose individuals suspected of having autism of varying ages, developmental levels, and language skills (from no speech to verbally fluent). The ADOS includes four modules, each requiring just 35-40 minutes to administer. The individual being evaluated is given just one of 4 modules, depending on his or her expressive language level and chronological age. The rater will observe social and communication behaviors during various activities in the appropriate module. A rater then uses a 0-3 scale to rate each type of behavior. A select number of individual items will be summed for a total score representing communication and reciprocal social interaction. In scoring all 3's are collapsed to a 2. A higher score indicates more severe impairment. Ranges of scores are as follows: Module 1: 0-24, Module 2: 0-24, Module 3: 0-22, Module 4: 0-22. |
| Secondary | Change in Mean Aberrant Behavior Checklist (ABC)-Social Withdrawal Subscale Score Over Both Periods | Baseline to 16 Weeks | Efficacy measures included the Aberrant Behavior Checklist -Social Withdrawal subscale scor. The ABC which focuses on problem behaviors in five subdomains, including irritability, attention, repetitive behaviors, unusual speech, and lethargy. A modified version of the lethargy subscale was used. Typically the Lethargy subscale includes 16 items, however, for our purposes 3 items that were specifically related to lethargy (i.e.: listlessness) were removed so that the focus could primarily be on aberrant social behavior. Differences in only the Social Withdrawal domain were assessed.The is the sum of items, each rated among 0 = Not at all; 1 = Slight in degree; 2 = Moderately serious; and 3 = Severe in degree. The ABC- Social Withdrawal total score ranges from 0 to 39. Higher values represent greater severity of illness. |
| Secondary | Change in Mean Pervasive Developmental Disorder Behavior Inventory - Screening Version (PDDBI-SV) Total Score Over Both Periods | Baseline to 16 Weeks | The PDDBI-SV examines both adaptive and maladaptive behaviors related to autism. It has normative scores for children between 2-11 years. For children 12 years and older, the norms (11 years, 11 months) will be used. Each item is scored on a scale from 0-3. For the first 9 items, the total of individual items is summed. For items 10-18, the scores are reversed and then summed (i.e.: 0=3, 1 =2, 2=2, 3 = 0). Then the total of 0-9 and then the reversed scored items 10-18 are summed for a final total score. Higher scores indicate more impairment. The range of total scores is 0-54. ASD/Social deficits unlikely: 0-6, More information needed/borderline: 7-10, autism spectrum disorder (ASD)/social deficits likely (mild):11-14, ASD/social deficits likely (moderate): 15-29, ASD/social deficits likely (severe): 30-37, ASD/social deficits likely (extreme): 38 or higher. |
| Secondary | Change in Mean Systolic Blood Pressure During Period 1 | Week 0 to 8 | Change in mean systolic blood pressure during double blind phase |
| Secondary | Mean Change in Prolactin Levels Over Period 1 | Week 0 to 8 | Serum prolactin levels were collected and analyzed in participants |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 registered outcomesOutcomes11
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants Who Could Tolerate Twice Daily Oxytocin | Week 0 to week 8 | This is over period 1, the double blind phase (week 0 to week 8) only | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants Who Could Tolerate Twice Daily Oxytocin | Week 0 to week 16 | all participants who recieved oxytocin at any time | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Change in Mean Plasma Oxytocin Level During Period 1 - Double Blind Phase | Week 0 to week 8 | participants with oxytocin plasma levels at baseline and week 8 | picograms/mL (pg/mL) | MEAN |
| SECONDARY | Change in Mean Weight | between weeks 0 and 8 | The subject who discontinued after 2 days did not have repeat assessments and is excluded from these analyses | pounds | MEAN |
| SECONDARY | Change in Mean Total Social Social Responsiveness Scale (SRS) T-score | 0-8 weeks, blinded treatment, period 1 | All participants with at least one post baseline assessment, 1 person from sequence 1 discontinued due to no post baseline measures | T-scores | MEAN |
| SECONDARY | Change in Mean Autism Diagnostic Observation Schedule (ADOS) Total Score | Baseline to 16 Weeks | 1 patient without post baseline measures is not included | scores on a scale | MEAN |
| SECONDARY | Change in Mean Aberrant Behavior Checklist (ABC)-Social Withdrawal Subscale Score Over Both Periods | Baseline to 16 Weeks | population of participants with all data available for mixed models analysis no data carried forward | scores on a scale | MEAN |
| SECONDARY | Change in Mean Pervasive Developmental Disorder Behavior Inventory - Screening Version (PDDBI-SV) Total Score Over Both Periods | Baseline to 16 Weeks | used only subjects with all data points no data carried forward | scores on a scale | MEAN |
| SECONDARY | Change in Mean Systolic Blood Pressure During Period 1 | Week 0 to 8 | The one subject who discontinued at week 1 did not have follow up data to include in the analysis. | millimeters of mercury (mmHg) | MEAN |
| SECONDARY | Mean Change in Prolactin Levels Over Period 1 | Week 0 to 8 | nanograms per milliliter (ng/mL) | MEAN |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 outcomesResults by group22
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants Who Could Tolerate Twice Daily Oxytocin | Sequence 2: Placebo:Oxytocin | 13 | Participants | ||
| Number of Participants Who Could Tolerate Twice Daily Oxytocin | Sequence 1: Oxytocin:Oxytocin | 11 | Participants | ||
| Number of Participants Who Could Tolerate Twice Daily Oxytocin | Sequence 2: Placebo:Oxytocin | 11 | Participants | ||
| Number of Participants Who Could Tolerate Twice Daily Oxytocin | Sequence 2: Oxytocin:Oxytocin | 11 | Participants | ||
| Change in Mean Plasma Oxytocin Level During Period 1 - Double Blind Phase | Sequence 2: Placebo:Oxytocin | -0.69 | Standard Deviation 1.69 | picograms/mL (pg/mL) | |
| Change in Mean Plasma Oxytocin Level During Period 1 - Double Blind Phase | Sequence 1: Oxytocin:Oxytocin | -0.15 | Standard Deviation 1.53 | picograms/mL (pg/mL) | |
| Change in Mean Weight | Sequence 1: Oxytocin-oxytocin | 1.4 | Standard Error 1.3 | pounds | |
| Change in Mean Weight | Sequence 2: Placebo :Oxytocin | 2.4 | Standard Error 0.7 | pounds | |
| Change in Mean Total Social Social Responsiveness Scale (SRS) T-score | Sequence 1: Oxytocin-oxytocin | -5.1 | Standard Error 2.3 | T-scores | |
| Change in Mean Total Social Social Responsiveness Scale (SRS) T-score | Sequence 2: Placebo :Oxytocin | -3.9 | Standard Error 3.3 | T-scores |
1 to 10 of 22Source ClinicalTrials.gov
See all 22 results by groupParticipant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Period 1: Double Blind Treatment | STARTED | Sequence 1: Oxytocin-oxytocin | 12 | |
| Period 1: Double Blind Treatment | STARTED | jSequence 2: Placebo-oxytocin | 13 | |
| Period 1: Double Blind Treatment | COMPLETED | Sequence 1: Oxytocin-oxytocin | 11 | |
| Period 1: Double Blind Treatment | COMPLETED | jSequence 2: Placebo-oxytocin | 13 | |
| Period 1: Double Blind Treatment | NOT COMPLETED | Sequence 1: Oxytocin-oxytocin | 1 | |
| Period 1: Double Blind Treatment | NOT COMPLETED | jSequence 2: Placebo-oxytocin | 0 | |
| Period 2: Open Label Treatment | STARTED | Sequence 1: Oxytocin-oxytocin | 11 | |
| Period 2: Open Label Treatment | STARTED | jSequence 2: Placebo-oxytocin | 13 | |
| Period 2: Open Label Treatment | COMPLETED | Sequence 1: Oxytocin-oxytocin | 11 | |
| Period 2: Open Label Treatment | COMPLETED | jSequence 2: Placebo-oxytocin | 11 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events48
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | # of participants with any adverse event | General disorders | Sequence 1: Oxytocin:Oxytocin Period 1weeks 0-8 | 12 | 12 | 59 |
| other | # of participants with any adverse event | General disorders | Sequence 2: Placebo: Oxytocin Period 1 Weeks 0-8 | 10 | 13 | 53 |
| other | # of participants with any adverse event | General disorders | Sequence 1: Oxytocin:Oxytocin Period 2, Weeks 8-16 | 7 | 11 | 19 |
| other | # of participants with any adverse event | General disorders | Sequence 2: Placebo:Oxytocin Period 2 | 12 | 13 | 46 |
| other | # with moderate adverse event | General disorders | Sequence 1: Oxytocin:Oxytocin Period 1weeks 0-8 | 5 | 12 | 16 |
| other | # with moderate adverse event | General disorders | Sequence 2: Placebo: Oxytocin Period 1 Weeks 0-8 | 9 | 13 | 20 |
| other | # with moderate adverse event | General disorders | Sequence 1: Oxytocin:Oxytocin Period 2, Weeks 8-16 | 3 | 11 | 5 |
| other | # with moderate adverse event | General disorders | Sequence 2: Placebo:Oxytocin Period 2 | 6 | 13 | 16 |
| other | # with severe adverse event | General disorders | Sequence 1: Oxytocin:Oxytocin Period 1weeks 0-8 | 5 | 12 | 12 |
| other | # with severe adverse event | General disorders | Sequence 2: Placebo: Oxytocin Period 1 Weeks 0-8 | 2 | 13 | 6 |
1 to 10 of 48Source ClinicalTrials.gov
See all 48 adverse eventsAdverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Sequence 1: Oxytocin:Oxytocin Period 1weeks 0-8 | 0 | 12 |
| Total, all-cause mortality | Sequence 2: Placebo: Oxytocin Period 1 Weeks 0-8 | 0 | 13 |
| Total, all-cause mortality | Sequence 1: Oxytocin:Oxytocin Period 2, Weeks 8-16 | 0 | 11 |
| Total, all-cause mortality | Sequence 2: Placebo:Oxytocin Period 2 | 0 | 13 |
| Total, other adverse events | Sequence 1: Oxytocin:Oxytocin Period 1weeks 0-8 | 12 | 12 |
| Total, other adverse events | Sequence 2: Placebo: Oxytocin Period 1 Weeks 0-8 | 10 | 13 |
| Total, other adverse events | Sequence 1: Oxytocin:Oxytocin Period 2, Weeks 8-16 | 8 | 11 |
| Total, other adverse events | Sequence 2: Placebo:Oxytocin Period 2 | 12 | 13 |
| Total, serious adverse events | Sequence 1: Oxytocin:Oxytocin Period 1weeks 0-8 | 1 | 12 |
| Total, serious adverse events | Sequence 2: Placebo: Oxytocin Period 1 Weeks 0-8 | 0 | 13 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Sequence 2: Placebo:Oxytocin vs Sequence 1: Oxytocin:Oxytocin: Number of Participants Who Could Tolerate Twice Daily Oxytocin | Trial comparisons |
| Sequence 2: Placebo:Oxytocin vs Sequence 2: Oxytocin:Oxytocin: Number of Participants Who Could Tolerate Twice Daily Oxytocin | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01308749
GET https://conductscience.org/api/trials/v1/NCT01308749/results?page=2