INtranasal OXyTocin for the Treatment of Autism Spectrum Disorders

Autism Spectrum Disorder Clinical Trial

— INOXT  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01788072
• Other study ID #: INOXT-10-2013
• Status: Completed
• Phase: Phase 2
• First received: February 7, 2013
• Last updated: January 23, 2018
• Start date: June 2014
• Est. completion date: October 2017

Study information

• Verified date: January 2018
• Source: Anagnostou, Evdokia, M.D.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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). 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: October 2017
• Est. primary completion date: August 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Autism Spectrum Disorder
• Autistic Disorder
• Child Development Disorders, Pervasive
• Disease

Intervention

Drug:
• Intranasal Oxytocin
24 IU taken twice daily (BID), in the morning and at noon/early afternoon
• Placebo
24 IU taken twice daily (BID), in the morning and at noon/early afternoon

Locations

Country	Name	City	State
Canada	St. Joseph's Healthcare Hamilton	Hamilton	Ontario
Canada	Holland Bloorview Kids Rehabilitation Hospital	Toronto	Ontario

Sponsors (4)

Lead Sponsor	Collaborator
Evdokia Anagnostou	Holland Bloorview Kids Rehabilitation Hospital, McMaster University, St. Michael's Hospital, Toronto

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).	12 weeks
Secondary	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	12 weeks
Secondary	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)	12 weeks
Secondary	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)	12 weeks
Secondary	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)	12 weeks
Secondary	Safety and tolerability of intranasal oxytocin in adults with ASD	This will be measured by the Safety Monitoring Uniform Report Form (SMURF)	12 weeks
Secondary	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)	12 weeks
Secondary	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)	12 weeks
Secondary	Efficacy of intranasal oxytocin vs. placebo on anxiety	This will be measured by the Symptom Checklist 90-Revised (SCL-90-R)	12 weeks