|
Main
|
|
Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
|
Register:
|
ClinicalTrials.gov |
|
Last refreshed on:
|
6 May 2013 |
|
Main ID: |
NCT01256060 |
|
Date of registration:
|
22/11/2010 |
|
Primary sponsor: |
|
|
Public title:
|
Intranasal Oxytocin for the Treatment of Children and Adolescents With ASD
|
|
Scientific title:
|
Intranasal Oxytocin for the Treatment of Children and Adolescents With Autism Spectrum Disorders (ASD) |
|
Date of first enrolment:
|
November 2010 |
|
Target sample size:
|
15 |
|
Recruitment status: |
Completed |
|
URL:
|
http://clinicaltrials.gov/show/NCT01256060 |
|
Study type:
|
Interventional |
|
Study design:
|
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
|
|
|
Countries of recruitment
|
|
Canada
|
United States
| | | | | | |
|
Contacts
|
|
Name:
|
Annie Dupuis, PhD |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
Holland Bloorview Kids Rehabilitation Hospital |
|
|
Name:
|
Evdokia Anagnostou, MD |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
Holland Bloorview Kids Rehabilitation Hospital |
|
|
Name:
|
Jessica Brian, PhD |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
Holland Bloorview Kids Rehabilitation Hospital |
|
|
Name:
|
Sharon Smile, MD |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
Holland Bloorview Kids Rehabilitation Hospital |
|
|
Name:
|
Margot Taylor, PhD |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
The Hospital for Sick Children |
|
|
Name:
|
Wendy Roberts, MD |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
The Hospital for Sick Children |
|
|
Name:
|
Edwin Cook, MD |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
University of Illinois |
|
|
Name:
|
Suma Jacob, MD, PhD |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
University of Illinois |
| |
|
Key inclusion & exclusion criteria
|
Inclusion Criteria:
1. Male or female outpatients 10-17 years of age inclusive.
2. Meet Diagnostic and Statistical Manual of Mental Disorders, 4th Edition, Text
Revision criteria. DSM-IV criteria for Autistic Disorder or Asperger's Disorder will
be established by a clinician with expertise with individuals with ASD. Best
estimate Diagnosis will be reached using DSM IV criteria, the Autism Diagnostic
Observation Schedule (ADOS-G) and the Autism Diagnostic Interview (ADI-R)
3. Have a Clinician's Global Impression-Severity (CGI-S) score = 4 (moderately ill) at
Baseline.
4. Verbal IQ >/= 70.
5. If already receiving stable pharmacological and or non-pharmacologic educational,
behavioral, and/or dietary interventions, have continuous participation during the
preceding 3 months prior to Screening and will not electively initiate new or modify
ongoing interventions for the duration of the study.
6. Have normal physical examination and laboratory test results at Screening. If
abnormal, the finding(s) must be deemed clinically insignificant by the Investigator.
7. The participant and caregiver must be able to speak and understand English
sufficiently to allow for the completion of all study assessments.
Exclusion Criteria:
1. Patients born prior to 35 weeks gestational age.
2. Patients with any primary psychiatric diagnosis other than autism at Screening.
3. Patients with current 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 MRI/structural lesion of the brain.
4. Pregnant female patients, sexually active female patients on hormonal birth control
and sexually active females who do not use two types of non-hormonal birth control
5. Patients with a medical condition that might interfere with the conduct of the study,
confound interpretation of the study results, or endanger their own well-being.
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 who are sensitive to Syntocinon or any components of its formulation
7. Patients with one or more of the following: HIV, HBV, HCV, hemophilia (bleeding
problems, recent nose and brain injuries), abnormal blood pressure (hypotension or
hypertension), drug abuse (meets DSM criteria), immunity disorder or severe
depression.
8. Patients unable to tolerate venipuncture procedures for blood sampling.
Age minimum:
10 Years
Age maximum:
17 Years
Gender:
Both
|
|
Health Condition(s) or Problem(s) studied
|
|
Autism Spectrum Disorder
|
|
Intervention(s)
|
|
Drug: Intranasal Oxytocin
|
|
Primary Outcome(s)
|
|
To determine the maximum tolerated dose to be used in the randomized study of intranasal oxytocin
[Time Frame: 24 Weeks]
|
|
To examine the safety and tolerability of intranasal oxytocin in youth with ASD
[Time Frame: 24 Weeks]
|
|
Secondary Outcome(s)
|
|
4. To examine whether changes of blood levels of oxytocin during the trial are related to safety or treatment response
[Time Frame: 12 Weeks]
|
|
To examine whether baseline levels of oxytocin are related to either safety or treatment response
[Time Frame: 12 Weeks]
|
|
Source(s) of Monetary Support
|
|
Please refer to primary and secondary sponsors
|
|