INOXT: INtranasal OXyTocin for the Treatment of Autism Spectrum Disorders

Sponsor

Evdokia Anagnostou (Other)

Overall Status

Completed

CT.gov ID

NCT01788072

Collaborator

Holland Bloorview Kids Rehabilitation Hospital (Other), McMaster University (Other), Unity Health Toronto (Other)

Enrollment

Locations

Arms

Duration (Months)

Patients Per Site

0.9

Patients Per Site Per Month

Study Details

Study Description

Brief 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). 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.

Condition or Disease	Intervention/Treatment	Phase
Autism Spectrum Disorder	Drug: Intranasal Oxytocin Drug: Placebo	Phase 2

Study Design

Study Type:

Interventional

Actual Enrollment :

70 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Jun 1, 2014

Actual Primary Completion Date :

Aug 1, 2017

Actual Study Completion Date :

Oct 1, 2017

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Intranasal Oxytocin	Drug: Intranasal Oxytocin 24 IU taken twice daily (BID), in the morning and at noon/early afternoon Other Names: Syntocinon
Placebo Comparator: Placebo	Drug: Placebo 24 IU taken twice daily (BID), in the morning and at noon/early afternoon

Arm

Intervention/Treatment

Active Comparator: Intranasal Oxytocin

Drug: Intranasal Oxytocin

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

Other Names:

Syntocinon

Placebo Comparator: Placebo

Drug: Placebo

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

Outcome Measures

Primary Outcome Measures

Efficacy of intranasal oxytocin vs. placebo on social function in adults with ASD [12 weeks]
This will be measured by the Clinical Global Impressions - Improvement Scale - Social (CGI-I-Social).

Secondary Outcome Measures

Efficacy of intranasal oxytocin vs. placebo on a continuous measure of social cognition in adults with ASD [12 weeks]
This will be measured by the Revised Eyes Test
Efficacy of intranasal oxytocin vs. placebo on a continuous measure of social function in adults with ASD [12 weeks]
This will be measured by the Vineland Adaptive Behavior Scale (VABS-II)
Efficacy of intranasal oxytocin vs. placebo on a continuous measure of social responsiveness in adults with ASD [12 weeks]
This will be measured by the Social Responsiveness Scale (SRS-2)
Efficacy of intranasal oxytocin vs. placebo on a continuous measure of social responsiveness in adults with ASD [12 weeks]
This will be measured by the Aberrant Behavior Checklist (ABC)
Safety and tolerability of intranasal oxytocin in adults with ASD [12 weeks]
This will be measured by the Safety Monitoring Uniform Report Form (SMURF)
Safety and tolerability of intranasal oxytocin in adults with ASD [12 weeks]
This will be measured by the Clinical Global Impressions - Improvement Scale - Global (CGI-I-Global)
Efficacy of intranasal oxytocin vs. placebo on quality of life [12 weeks]
This will be measured by the World Health Organization Quality of Life Survey (WHOQOL-BREF)
Efficacy of intranasal oxytocin vs. placebo on anxiety [12 weeks]
This will be measured by the Symptom Checklist 90-Revised (SCL-90-R)

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 45 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria

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
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.

Exclusion Criteria

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.
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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	St. Joseph's Healthcare Hamilton	Hamilton	Ontario	Canada	L8S 4K1
2	Holland Bloorview Kids Rehabilitation Hospital	Toronto	Ontario	Canada	M4G 1R8

Sponsors and Collaborators

Evdokia Anagnostou
Holland Bloorview Kids Rehabilitation Hospital
McMaster University
Unity Health Toronto

Investigators

Principal Investigator: Evdokia Anagnostou, M.D., Holland Bloorview Kids Rehabilitation Hospital
Principal Investigator: Marc Woodbury-Smith, M.D., McMaster University