Autism Spectrum DisordersINOTNCT01337687
Intranasal Oxytocin for the Treatment of Autism Spectrum Disorders
A study testing Intranasal Oxytocin in people with Autism Spectrum Disorders, run by Montefiore Medical Center at 1 site in United States.
Trial summary
Autism Spectrum Disorder (ASD) is a developmental disorder characterized by abnormalities in speech and communication, impaired social functioning and repetitive behaviors and restricted interests. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Autism Spectrum Disorders
- What is being tested?
- Intranasal Oxytocin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 19 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2009to Dec 2013
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Male and Female
- 18 to 55 years old
- Meet Diagnostic and Statistical Manual-IV (DSM-IV), Autism Diagnostic Observation Schedule(ADOS), and Autism Diagnostic Interview-Revised (ADI-R) standards for Autism Spectrum Disorder or Aspergers Syndrome
- Have a high, normal or near normal Intelligent Quotient
- Speak and Understand English fluently
Who cannot join
- Born prior to 35 weeks gestational age
- Any primary psychiatric diagnosis other than autism at the time of screening
- Medical history of neurological disease
- Medical history of known MRI/structural lesion of the brain
- Patients who are pregnant
- With a medical condition that might interfere with the conduct of the study, confound interpretation of study results or endanger their own well being
Show all 10Show fewer
- With evidence or history of malignancy or any significant hematological, endocrine, cardiovascular, respiratory, renal, hepatic or gastrointestinal disease
- Taking psychoactive medications
- Who plan to initiate or change nonpharmacologic interventions during the study course
- Who are unable to tolerate venipuncture procedures for blood sampling
Trial locations and contacts
1 site in 1 country.
United States1 site
Montefiore Medical Center, Albert Einstein College of Medicine
The Bronx, New York, 10467
About this study
Autism Spectrum Disorder (ASD) is a developmental disorder characterized by abnormalities in speech and communication, impaired social functioning and repetitive behaviors and restricted interests. Oxytocin (OT) is peptide that is known for its peripheral effects on facilitating uterine contractions and milk let-down; however, studies, mainly with rodents and non-human primates, has found that OT is involved in affiliative behaviors, including sexual behavior, mother-infant and adult-adult pair-bond formation, separation distress, and other aspects of social attachment. Moreover, OT is known to play an important role in repetitive behaviors and stress reactivity. Given that repetitive behaviors and deficits in social interaction are core symptom domains of autism, and that OT is involved in the regulation of repetitive and affiliative behaviors, it is believed that OT may play a role in the etiology of autism. Moreover, preliminary data obtained by Hollander and colleagues suggests that OT may be of value in treating core autism symptoms. Specifically, synthetic oxytocin administered via intravenous infusion to adults with autism spectrum disorders (ASD) produced significant reductions in repetitive behaviors and facilitated social cognition/memory in a double-blind, placebo-controlled cross-over laboratory challenge.
Encouraged by these findings, the primary aim of this study is to investigate the safety and therapeutic efficacy of intranasal OT in treating repetitive behaviors and social functioning/cognitive deficits in adults with ASD. This research embraces a translational approach to develop a novel treatment for core ASD symptoms; given that there are currently no Food and Drug Administration (FDA) approved medication treatments for core ASD symptoms, this research addresses an important unmet need in the field. The goal of this study is to evaluate the safety and efficacy of repeated Intranasal Oxytocin Treatment (INOT)administration in adults with ASD.
- Conditions
- Autism Spectrum Disorders
- Being tested
- Intranasal Oxytocin, Placebo
- Keywords
- Autism, Autism Spectrum Disorders, Oxytocin, Hollander, ASD, Asperger Syndrome, Asperger
- Medical subject headings
- Autism Spectrum Disorder, Autistic Disorder, Asperger Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intranasal OxytocinDrug
Oxytocin administered intranasally twice a day via 1 12 unit puff to each nostril, totaling 48 IU a day.
PlaceboDrug
Saline will be administered intranasally twice a day via 1 puff per nostril, totaling 48 IU a day.
| Study group | Role | What they receive |
|---|---|---|
| Oxytocin | Experimental | Not described Receives: Drug: Intranasal Oxytocin |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Improvement on the Clinical Global Impression-Improvement (CGI-I) Scale
Rating Scale that utilizes direct observation, scales and patient report to inform clinical judgment. A form of CGI that targets social functioning will be used as the primary outcome measure. Semi-structured interview.
Measured: 6 Weeks
Secondary outcomes (3)
Change in Obsessive- Compulsive Behavior Based on Yale Brown Obsessive Compulsive Scale (YBOCS)
Clinician-Rated questionnaire measuring the time spent, distress,interference, resistance, and control in relation to obsessions and compulsions based on a 5 point scale ranging from 0-5 for each category with 0 being most desirable and 5 being least. Sub-scales are added and averaged to obtain total scores.
-scale range (total): 0 - 40 total, 0 - 7 subclinical, 8-15 mild, 16 - 23 moderate, 24 - 31 severe, 32 - 40 extreme
Questions are rated on a 5-point scale, 0-4, increasing in severity. Obsession Rating Subscale (5 questions, ranging from 0 - 20 total) and Compulsion Rating subscale (5 questions, ranging from 0 - 20 total) are totaled and added to obtain total scores.
-score interpretation: Higher overall scores reflect increasing symptom severity.
Measured: Baseline, Week 6
Change in Repetitive Behavior Based Repetitive Behavior Scale - Revised (RBS-R)
Subscale ranges: stereotypic behavior (0 - 27);self-injurious behavior (0 - 24); compulsive behavior (0 - 18); ritualistic/Sameness Behavior (0 - 36); restricted Interests (0 - 9).
Higher score in all subscales reflect increasing severity. Questions rate behaviors on a 4-point scale: 0 = does not occur; 1 = occurs, mild problem; 2 = occurs, moderate problem; 3 = occurs, severe problem. Subscale scores consist of sum of ratings within each question subset.
Lower order behaviors-- stereotypy and self-injury, higher order behaviors--compulsions, rituals /sameness, restricted interests.
Lower Order total range: 0-51, Higher Order total range: 0-63 Stereotypic behavior and Self-injurious behavior subscales were summed to create a total range for Lower Order behavior; and Compulsive behavior, ritualistic /sameness behavior, and restricted interests subscales were summed to create a total range for Higher Order behavior.
Measured: Baseline, week 6
Change in Facial Emotion Recognition Based on Diagnostic Analysis of Nonverbal Accuracy - 2 (DANVA-2)
A clinical tool measuring emotion recognition through facial expression, voice and posture.
- Child faces 2 (range 0 - 100, higher values reflecting higher % of errors)
- Adult faces 2 (range 0 - 100, higher values reflecting higher % of errors)
- Child paralanguage 2 (range 0 - 100, higher values reflecting higher % of errors)
- Adult paralanguage 2 (range 0 - 100, higher values reflecting higher % of errors) Errors are counted and organized by pre-determined affect and intensity. Subtests considered separately.
Measured: baseline, week 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2011 (estimated)
- Study startOct 2009
- Primary completionDec 2013
- Study completionDec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Autism Spectrum DisordersStudies of the same condition, open and under way.
- More trials run by Montefiore Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- Montefiore Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Alliance for Research on Schizophrenia and Depression
- Responsible party
- Principal investigator, Eric Hollander, Montefiore Medical Center
- Investigators
- Eric Hollander, MD, Principal investigator, Montefiore Medical Center/Albert Einstein College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01337687
- Sponsor's protocol ID
- 09-10-303
- Acronym
- INOT
- Status last verified
- Feb 2020
- First submitted
- 15 Dec 2010
- Last updated
- 27 Feb 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Iffland M, Livingstone N, Jorgensen M, Hazell P, Gillies D. Pharmacological intervention for irritability, aggression, and self-injury in autism spectrum disorder (ASD). Cochrane Database Syst Rev. 2023 Oct 9;10(10):CD011769. doi: 10.1002/14651858.CD011769.pub2.
PubMed 37811711
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intranasal Oxytocin for the Treatment of Autism Spectrum Disorders
- ClinicalTrials.gov ID
- NCT01337687
- Acronym / sponsor ID
- INOT / 09-10-303
- Conditions
- Autism Spectrum Disorders
- Keywords
- Autism, Autism Spectrum Disorders, Oxytocin, Hollander, ASD, Asperger Syndrome, Asperger
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- Montefiore Medical CenterUniversity, hospital or other
- Collaborators
- National Alliance for Research on Schizophrenia and Depression
- Study start
- Oct 2009
- Primary completion
- Dec 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 19 Apr 2011 (estimated)
- Results
- Posted 27 Feb 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Autism Spectrum Disorder (ASD) is a developmental disorder characterized by abnormalities in speech and communication, impaired social functioning and repetitive behaviors and restricted interests. Oxytocin (OT) is peptide that is known for its peripheral effects on facilitating uterine contractions and milk let-down; however, studies, mainly with rodents and non-human primates, has found that OT is involved in affiliative behaviors, including sexual behavior, mother-infant and adult-adult pair-bond formation, separation distress, and other aspects of social attachment. Moreover, OT is known to play an important role in repetitive behaviors and stress reactivity. Given that repetitive behaviors and deficits in social interaction are core symptom domains of autism, and that OT is involved in the regulation of repetitive and affiliative behaviors, it is believed that OT may play a role in the etiology of autism. Moreover, preliminary data obtained by Hollander and colleagues suggests that OT may be of value in treating core autism symptoms. Specifically, synthetic oxytocin administered via intravenous infusion to adults with autism spectrum disorders (ASD) produced significant reductions in repetitive behaviors and facilitated social cognition/memory in a double-blind, placebo-controlled cross-over laboratory challenge.
Encouraged by these findings, the primary aim of this study is to investigate the safety and therapeutic efficacy of intranasal OT in treating repetitive behaviors and social functioning/cognitive deficits in adults with ASD. This research embraces a translational approach to develop a novel treatment for core ASD symptoms; given that there are currently no Food and Drug Administration (FDA) approved medication treatments for core ASD symptoms, this research addresses an important unmet need in the field. The goal of this study is to evaluate the safety and efficacy of repeated Intranasal Oxytocin Treatment (INOT)administration in adults with ASD.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Oxytocin | Experimental | Drug: Intranasal Oxytocin |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Male and Female
- 18 to 55 years old
- Meet Diagnostic and Statistical Manual-IV (DSM-IV), Autism Diagnostic Observation Schedule(ADOS), and Autism Diagnostic Interview-Revised (ADI-R) standards for Autism Spectrum Disorder or Aspergers Syndrome
- Have a high, normal or near normal Intelligent Quotient
- Speak and Understand English fluently
Key exclusion criteria (10 listed)
- Born prior to 35 weeks gestational age
- Any primary psychiatric diagnosis other than autism at the time of screening
- Medical history of neurological disease
- Medical history of known MRI/structural lesion of the brain
- Patients who are pregnant
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intranasal OxytocinOxytocin administered intranasally twice a day via 1 12 unit puff to each nostril, totaling 48 IU a day. | Drug | Oxytocin |
| PlaceboSaline will be administered intranasally twice a day via 1 puff per nostril, totaling 48 IU a day. | Drug | Placebo |
Primary outcome
Number of Participants With Improvement on the Clinical Global Impression-Improvement (CGI-I) Scale
Time frame: 6 Weeks
Rating Scale that utilizes direct observation, scales and patient report to inform clinical judgment. A form of CGI that targets social functioning will be used as the primary outcome measure. Semi-structured interview.
3 secondary outcomes
Change in Obsessive- Compulsive Behavior Based on Yale Brown Obsessive Compulsive Scale (YBOCS)
Time frame: Baseline, Week 6
Change in Repetitive Behavior Based Repetitive Behavior Scale - Revised (RBS-R)
Time frame: Baseline, week 6
Change in Facial Emotion Recognition Based on Diagnostic Analysis of Nonverbal Accuracy - 2 (DANVA-2)
Time frame: baseline, week 6
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 37811711Iffland M, Livingstone N, Jorgensen M, Hazell P, Gillies D. Pharmacological intervention for irritability, aggression, and self-injury in autism spectrum disorder (ASD). Cochrane Database Syst Rev. 2023 Oct 9;10(10):CD011769. doi: 10.1002/14651858.CD011769.pub2.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eric Hollander, MD principal investigator
Montefiore Medical Center/Albert Einstein College of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intranasal Oxytocin in people with Autism Spectrum Disorders, run by Montefiore Medical Center at 1 site in United States.
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 5 inclusion and 10 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 27 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 27 Feb 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Participants With Improvement on the Clinical Global Impression-Improvement (CGI-I) Scale (time frame: 6 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 NCT01337687, which also lists 1 linked publication.
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 27 Feb 2020.