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Autism Spectrum DisorderPhase 2INOXTNCT01788072

INtranasal OXyTocin for the Treatment of Autism Spectrum Disorders

A Phase 2 study testing Intranasal Oxytocin in people with Autism Spectrum Disorder, run by Holland Bloorview Kids Rehabilitation Hospital at 2 sites in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

There is substantial evidence from animal model and healthy control data, that oxytocin is involved in the modulation of social cognition. In addition, recent genetics and plasma level studies suggest a possible role for oxytocin in the pathophysiology of Autism Spectrum Disorders (ASD). Read more about this study

Who is it for?
Ages 18 to 45 years
Conditions the study is for
Autism Spectrum Disorder
What is being tested?
Intranasal Oxytocin
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
70 participants
Where
2 sitesCanada
Study dates
Jun 2014to Oct 2017
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 45 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • Male or female outpatients 18-45 years of age, inclusive
  • Meet Diagnostic and Statistical Manual of Mental Disorders. Diagnostic and Statistical Manual (DSM-V) criteria will be established by a clinician with expertise with individuals with ASD. Best estimate Diagnosis will be reached using DSM-V criteria, the Autism Diagnostic Observation Schedule (ADOS) and the Autism Diagnostic Interview (ADI-R).
  • Have a Clinical Global Impression-Severity (CGI-S) score ≥ 4 (moderately ill) at Screening.
  • Verbal scale Intelligence Quotient (IQ) ≥ 70
  • If already receiving stable concomitant medications affecting behavior, have stable regimens with no changes during the preceding 1 month prior to Screening (with the exception of fluoxetine, where a period of 6 weeks is needed), and will not electively initiate new or modify ongoing medications for the duration of the study
  • If already receiving stable non-pharmacological educational, behavioral, and/or dietary interventions, have continuous participation during the preceding 3 months prior to Screening, and not electively initiate new or modify ongoing interventions for the duration of the study
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  • Have normal physical examination and laboratory test results at screening. If abnormal, the finding(s) must be deemed clinically insignificant by the Treating Clinician.
  • Ability to speak and understand English sufficiently to allow for the completion of all study assessments
  • Ability to obtain written informed consent from the subject (if developmentally appropriate), or ability to obtain written informed consent from their surrogate decision maker (SDM), if the subject is unable to provide consent.

Who cannot join

  • Patients born prior to 28 weeks gestational age
  • Patients with a primary psychiatric diagnosis other than ASD
  • Patients with a medical history of neurological disease, including, but not limited to, epilepsy/seizure disorder, movement disorder, tuberous sclerosis, fragile X, and any other known genetic syndromes, or known abnormal brain MRI/structural lesion. Exceptions: 1) simple febrile seizures, 2) epilepsy/ seizure free for at least 2 years prior to Screening
  • Pregnant female patients, sexually active female patients on hormonal birth control and sexually active females who do not use at least two types of non-hormonal birth control
  • Patients with evidence or history of malignancy or any significant hematological, endocrine, cardiovascular (including any rhythm disorder), respiratory, renal, hepatic, or gastrointestinal disease
  • Patients with one or more of the following: HIV, Hepatitis B virus, Hepatitis C virus, hemophilia (bleeding problems, recent nose and brain injuries), abnormal blood pressure (hypotension or hypertension), drug abuse, immunity disorder or severe depression.
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  • Patients unable to tolerate venipuncture procedures for blood sampling
  • Patients who are currently taking oxytocin or have taken intranasal oxytocin in the past with no response
  • Patients with a sensitivity to oxytocin or any components of its formulation

Trial locations and contacts

2 sites in 1 country.

Canada2 sites

  • St. Joseph's Healthcare Hamilton

    Hamilton, Ontario, L8S 4K1

  • Holland Bloorview Kids Rehabilitation Hospital

    Toronto, Ontario, M4G 1R8

Other trials in Canada

About this study

Official title: INtranasal OXyTocin for the Treatment of Autism Spectrum Disorders (ASD)

There is substantial evidence from animal model and healthy control data, that oxytocin is involved in the modulation of social cognition. In addition, recent genetics and plasma level studies suggest a possible role for oxytocin in the pathophysiology of Autism Spectrum Disorders (ASD). As a large number of children with ASD are transitioning into adulthood and will likely require treatment, the lack of data to make meaningful treatment recommendations to facilitate adult living is an urgent issue. This study will examine the effect of intranasal oxytocin (IN-OXT) on social function in adults with ASD. It is hypothesized that IN-OXT will be superior to placebo in improving social function by the end of study treatment.

Being tested
Intranasal Oxytocin, Placebo
Keywords
Autism Spectrum Disorders, Oxytocin, Adults
Medical subject headings
Autism Spectrum Disorder

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Intranasal OxytocinDrug

    Also called Syntocinon

    24 IU taken twice daily (BID), in the morning and at noon/early afternoon

  • PlaceboDrug

    24 IU taken twice daily (BID), in the morning and at noon/early afternoon

Study groups in NCT01788072
Study groupRoleWhat they receive
Intranasal OxytocinActive comparatorNot described
Receives: Drug: Intranasal Oxytocin
PlaceboPlacebo comparatorNot described
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Efficacy of intranasal oxytocin vs. placebo on social function in adults with ASD

    This will be measured by the Clinical Global Impressions - Improvement Scale - Social (CGI-I-Social).

    Measured: 12 weeks

Secondary outcomes (8)

  1. Efficacy of intranasal oxytocin vs. placebo on a continuous measure of social cognition in adults with ASD

    This will be measured by the Revised Eyes Test

    Measured: 12 weeks

  2. Efficacy of intranasal oxytocin vs. placebo on a continuous measure of social function in adults with ASD

    This will be measured by the Vineland Adaptive Behavior Scale (VABS-II)

    Measured: 12 weeks

  3. Efficacy of intranasal oxytocin vs. placebo on a continuous measure of social responsiveness in adults with ASD

    This will be measured by the Social Responsiveness Scale (SRS-2)

    Measured: 12 weeks

  4. Efficacy of intranasal oxytocin vs. placebo on a continuous measure of social responsiveness in adults with ASD

    This will be measured by the Aberrant Behavior Checklist (ABC)

    Measured: 12 weeks

  5. Safety and tolerability of intranasal oxytocin in adults with ASD

    This will be measured by the Safety Monitoring Uniform Report Form (SMURF)

    Measured: 12 weeks

  6. Safety and tolerability of intranasal oxytocin in adults with ASD

    This will be measured by the Clinical Global Impressions - Improvement Scale - Global (CGI-I-Global)

    Measured: 12 weeks

  7. Efficacy of intranasal oxytocin vs. placebo on quality of life

    This will be measured by the World Health Organization Quality of Life Survey (WHOQOL-BREF)

    Measured: 12 weeks

  8. Efficacy of intranasal oxytocin vs. placebo on anxiety

    This will be measured by the Symptom Checklist 90-Revised (SCL-90-R)

    Measured: 12 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Feb 2013 (estimated)
  2. Study startJun 2014
  3. Primary completionAug 2017
  4. Study completionOct 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
70 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01788072
Sponsor's protocol ID
INOXT-10-2013
Acronym
INOXT
Status last verified
Jan 2018
First submitted
7 Feb 2013
Last updated
16 Jul 2025
Results posted
No
Data monitoring committee
Yes
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Intranasal Oxytocin in people with Autism Spectrum Disorder, run by Holland Bloorview Kids Rehabilitation Hospital at 2 sites in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 16 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Efficacy of intranasal oxytocin vs. placebo on social function in adults with ASD (time frame: 12 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01788072.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jul 2025.

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