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

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2016 by Anagnostou, Evdokia, M.D.
Sponsor:
Collaborators:
Holland Bloorview Kids Rehabilitation Hospital
McMaster University
St. Michael's Hospital, Toronto
Information provided by (Responsible Party):
Evdokia Anagnostou, Anagnostou, Evdokia, M.D.
ClinicalTrials.gov Identifier:
NCT01788072
First received: February 7, 2013
Last updated: February 9, 2016
Last verified: February 2016
  Purpose
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 Intervention Phase
Autism Spectrum Disorder
Drug: Intranasal Oxytocin
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: INtranasal OXyTocin for the Treatment of Autism Spectrum Disorders (ASD)

Resource links provided by NLM:


Further study details as provided by Anagnostou, Evdokia, M.D.:

Primary Outcome Measures:
  • Efficacy of intranasal oxytocin vs. placebo on social function in adults with ASD [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    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 [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    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 [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    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 [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    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 [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    This will be measured by the Aberrant Behavior Checklist (ABC)

  • Safety and tolerability of intranasal oxytocin in adults with ASD [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
    This will be measured by the Safety Monitoring Uniform Report Form (SMURF)

  • Safety and tolerability of intranasal oxytocin in adults with ASD [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    This will be measured by the World Health Organization Quality of Life Survey (WHOQOL-BREF)

  • Efficacy of intranasal oxytocin vs. placebo on anxiety [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    This will be measured by the Symptom Checklist 90-Revised (SCL-90-R)


Estimated Enrollment: 146
Study Start Date: June 2014
Estimated Study Completion Date: March 2017
Estimated Primary Completion Date: March 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Intranasal Oxytocin Drug: Intranasal Oxytocin
24 IU taken twice daily (BID), in the morning and at noon/early afternoon
Other Name: Syntocinon
Placebo Comparator: Placebo Drug: Placebo
24 IU taken twice daily (BID), in the morning and at noon/early afternoon

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria

  1. Male or female outpatients 18-45 years of age, inclusive
  2. 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).
  3. Have a Clinical Global Impression-Severity (CGI-S) score ≥ 4 (moderately ill) at Screening.
  4. Verbal scale Intelligence Quotient (IQ) ≥ 70
  5. 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
  6. 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
  7. Have normal physical examination and laboratory test results at screening. If abnormal, the finding(s) must be deemed clinically insignificant by the Treating Clinician.
  8. Ability to speak and understand English sufficiently to allow for the completion of all study assessments
  9. 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

  1. Patients born prior to 28 weeks gestational age
  2. Patients with a primary psychiatric diagnosis other than ASD
  3. 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
  4. 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
  5. Patients with evidence or history of malignancy or any significant hematological, endocrine, cardiovascular (including any rhythm disorder), respiratory, renal, hepatic, or gastrointestinal disease
  6. 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.
  7. Patients unable to tolerate venipuncture procedures for blood sampling
  8. Patients who are currently taking oxytocin or have taken intranasal oxytocin in the past with no response
  9. Patients with a sensitivity to oxytocin or any components of its formulation
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01788072

Contacts
Contact: Evdokia Anagnostou, M.D. 416-425-6220 ext 6005 eanagnostou@hollandbloorview.ca
Contact: Dina Odrobina, B.MSc 416-425-6220 ext 6602 dodrobina@hollandbloorview.ca

Locations
Canada, Ontario
St. Joseph's Healthcare Hamilton Recruiting
Hamilton, Ontario, Canada, L8S 4K1
Contact: Iulia Patriciu, M.A.    905-521-2100 ext 39774    ipatrici@mcmaster.ca   
Principal Investigator: Marc Woodbury-Smith, M.D.         
Holland Bloorview Kids Rehabilitation Hospital Recruiting
Toronto, Ontario, Canada, M4G 1R8
Contact: Rianne Hastie Adams, M.S.W.    416-425-6220 ext 6515    rhastieadams@hollandbloorview.ca   
Principal Investigator: Evdokia Anagnostou, M.D.         
Sponsors and Collaborators
Evdokia Anagnostou
Holland Bloorview Kids Rehabilitation Hospital
McMaster University
St. Michael's Hospital, Toronto
Investigators
Principal Investigator: Evdokia Anagnostou, M.D. Holland Bloorview Kids Rehabilitation Hospital
Principal Investigator: Marc Woodbury-Smith, M.D. McMaster University
  More Information

Responsible Party: Evdokia Anagnostou, Principal Investigator, Anagnostou, Evdokia, M.D.
ClinicalTrials.gov Identifier: NCT01788072     History of Changes
Other Study ID Numbers: INOXT-10-2013 
Study First Received: February 7, 2013
Last Updated: February 9, 2016
Health Authority: Canada: Health Canada
Individual Participant Data  
Plan to Share IPD: No

Keywords provided by Anagnostou, Evdokia, M.D.:
Autism Spectrum Disorders
Oxytocin
Adults

Additional relevant MeSH terms:
Disease
Autistic Disorder
Autism Spectrum Disorder
Child Development Disorders, Pervasive
Neurodevelopmental Disorders
Mental Disorders
Pathologic Processes
Oxytocin
Oxytocics
Reproductive Control Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on July 28, 2016