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

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 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: June 18, 2014
Last verified: June 2014
  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:
  • To identify the effect of IN oxytocin (IN-OXT) vs. placebo on social function in adults with ASD. [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    Social function will be assessed using the Clinical Global Impressions Scale - Improvement - Social (CGI-I- Social).


Secondary Outcome Measures:
  • To identify the effect of IN oxytocin (IN-OXT) vs. placebo on continuous measures of social cognition and responsiveness in adults with ASD. [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    Social cognition will be assessed through the Reading the Mind in the Eyes Test (RMET) and the Diagnostic Analysis of Nonverbal Accuracy-2 (DANVA-2), and social responsiveness will be assessed through the Social Responsiveness Scale (SRS).

  • To determine the safety and tolerability of IN-OXT in adults with ASD. [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
    Safety will be assessed through the Safety Monitoring Uniform Report Form (SMURF) and Wide Range Assessment of Memory and Learning- Second Edition (WRAML-2).

  • To examine the effect of IN-OXT vs. placebo on quality of life and anxiety. [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    Quality of life will be assessed through the World Health Organization Quality of Life Survey (WHOQOL-BREF) and anxiety will be assessed through the Symptom Checklist 90-Revised (SCL-90-R)


Estimated Enrollment: 146
Study Start Date: June 2014
Estimated Study Completion Date: December 2016
Estimated Primary Completion Date: March 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Intranasal Oxytocin Drug: Intranasal Oxytocin
24 IU taken BID, in the morning and at noon/early afternoon
Other Name: Syntocinon
Placebo Comparator: Placebo Drug: Placebo
24 IU taken BID, in the morning and at noon/early afternoon

  Eligibility

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

Inclusion Criteria:

  • Male or female outpatients 18-45 years of age
  • Meet DSM-IV criteria for ASD
  • Have a Clinical Global Impression-Severity (CGI-S) score ≥ 4 (moderately ill) at Baseline.
  • Verbal and performance scale IQ ≥ 70 (both subtests of the WASI ≥ 70)
  • If already receiving stable pharmacologic, educational, behavioural, and/or dietary interventions, have stable regimes with no changes during the preceding 3 months prior to screening, and will 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 QI/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 (except simple febrile seizures), movement disorder, tuberous sclerosis, fragile X, and any other known genetic syndromes, or known abnormal brain MRI/structural lesion
  • 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 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
  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, MD 416-425-6220 ext 6005 eanagnostou@hollandbloorview.ca
Contact: Dina Zaghloul, B.MSc 416-425-6220 ext 6602 dzaghloul@hollandbloorview.ca

Locations
Canada, Ontario
St. Joseph's Healthcare Hamilton Not yet recruiting
Hamilton, Ontario, Canada, L8S 4K1
Contact: Iulia Patriciu, M.A.    (905) 521-2100 ext 74906    ipatrici@mcmaster.ca   
Principal Investigator: Marc Woodbury-Smith, MD         
Holland Bloorview Kids Rehabilitation Hospital Recruiting
Toronto, Ontario, Canada, M4G 1R8
Contact: Allyson Graham, MSc.    416-425-6220 ext 6515    allyson.graham@hollandbloorview.ca   
Principal Investigator: Evdokia Anagnostou, MD         
Sponsors and Collaborators
Evdokia Anagnostou
Holland Bloorview Kids Rehabilitation Hospital
McMaster University
St. Michael's Hospital, Toronto
Investigators
Principal Investigator: Evdokia Anagnostou, MD Holland Bloorview Kids Rehabilitation Hospital
Principal Investigator: Peter Szatmari, MD McMaster University
Principal Investigator: Marc Woodbury-Smith, MD McMaster University
Principal Investigator: Jeremy Goldberg, MD McMaster University
Principal Investigator: Kevin Thorpe, MMath Applied Health Research Centre, St Michael's Hospital ; Dalla Lana School of Public Health, University of Toronto
Principal Investigator: Jessica Brian, PhD Holland Bloorview Kids Rehabilitation Hospital
  More Information

No publications provided

Responsible Party: Evdokia Anagnostou, Principal Investigator, Anagnostou, Evdokia, M.D.
ClinicalTrials.gov Identifier: NCT01788072     History of Changes
Other Study ID Numbers: INOXT
Study First Received: February 7, 2013
Last Updated: June 18, 2014
Health Authority: Canada: Health Canada

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

Additional relevant MeSH terms:
Autistic Disorder
Child Development Disorders, Pervasive
Disease
Mental Disorders
Mental Disorders Diagnosed in Childhood
Pathologic Processes
Oxytocin
Oxytocics
Pharmacologic Actions
Physiological Effects of Drugs
Reproductive Control Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 23, 2014