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An Open-Label Trial of Oxytocin in Adolescents With Autism Spectrum Disorders

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ClinicalTrials.gov Identifier: NCT01931033
Recruitment Status : Active, not recruiting
First Posted : August 29, 2013
Last Update Posted : August 25, 2020
Sponsor:
Information provided by (Responsible Party):
Gagan Joshi, Massachusetts General Hospital

Tracking Information
First Submitted Date  ICMJE August 22, 2013
First Posted Date  ICMJE August 29, 2013
Last Update Posted Date August 25, 2020
Study Start Date  ICMJE October 2013
Estimated Primary Completion Date June 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 26, 2013)
Social Responsiveness Scale (SRS-2) [ Time Frame: Week-8 ]
A 65-item rating scale completed by the secondary reporter used to measure the severity of autism spectrum symptoms as they occur in natural settings.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 26, 2013)
Clinical Global Impression of PDD - Improvement (CGI-I) [ Time Frame: Week-8 ]
The CGI is a measure of illness severity, improvement, and efficacy of treatment (National Institute of Mental Health, 1985). The score for Improvement ranges from 1 (very much improved) to 7 (very much worse).
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE An Open-Label Trial of Oxytocin in Adolescents With Autism Spectrum Disorders
Official Title  ICMJE An Open-Label Trial of Oxytocin in Adolescents With Autism Spectrum Disorders
Brief Summary This study is an 8-week open-label trial testing oxytocin nasal spray (Syntocinon) as a treatment for social impairment in adolescents with autism spectrum disorders (ASD). We hypothesize that oxytocin nasal spray will be safe, tolerable, and effective in improving the core symptoms of autism spectrum disorders in adolescents ages 11-17.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Autism Spectrum Disorders
  • Pervasive Developmental Disorders
  • ASD
  • PDD
Intervention  ICMJE Drug: Intranasal Oxytocin
Other Name: Syntocinon
Study Arms  ICMJE Experimental: Oxytocin
Intranasal Oxytocin (brand name Syntocinon) will be administered daily (for a total daily dose of 48 IU) for 8 weeks.
Intervention: Drug: Intranasal Oxytocin
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Estimated Enrollment  ICMJE
 (submitted: August 26, 2013)
40
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 2021
Estimated Primary Completion Date June 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria

  1. Male and female outpatients ages 11-17 years
  2. DSM-IV-TR PDD diagnosis of autistic disorder, Asperger's disorder, or PDD-NOS as established by clinical diagnostic interview and with the aid of the MGH ASD Symptom Checklist (MGH-ASD-SCL).
  3. At least moderate severity of ASD impairment as measured by a raw score of ≥80 on the SRS and a severity score of ≥4 on CGI-PDD.
  4. Participants and their parent/guardian must be able to speak and understand English sufficiently to comprehend the nature of the study and to allow for the completion of all study procedures required per protocol.
  5. Subjects and their parent/guardian must be considered reliable reporters.
  6. Each subject and their parent/guardian must understand the nature of the study and provide written informed assent/consent.
  7. Subjects must be able to participate in mandatory blood draws.
  8. Subjects with mood, anxiety, or disruptive behavior disorders will be allowed to participate in the study provided they do not meet any exclusionary criteria.

Exclusion Criteria

  1. IQ <85
  2. Total lack of spoken language
  3. DSM-IV-TR PDD diagnosis of Rett's disorder or childhood disintegrative disorder.
  4. Clinically unstable psychiatric conditions or judged to be at serious suicidal risk as determined by evaluating investigator.
  5. History of substance use (except nicotine or caffeine) within past 3 months
  6. Serious, stable or unstable systemic illness including hepatic, renal, gastroenterological, respiratory, cardiovascular (including ischemic heart disease), endocrinologic, neurologic, immunologic, or hematologic disease.
  7. Subjects with severe hepatic impairment (LFTs > 3 times ULN) and those with severely impaired renal function (eGFR < 30).
  8. Pregnant or nursing females.
  9. Known hypersensitivity to oxytocin.
  10. Severe allergies or multiple adverse drug reactions.
  11. A non-responder or history of intolerance to oxytocin, after treatment at adequate doses as determined by the clinician.
  12. Subjects with significant nasal pathology (including atrophic rhinitis, recurrent nose bleeds, and history of hypophysectomy).
  13. Investigator and his/her immediate family defined as the investigator's spouse, parent, child, grandparent, or grandchild.
  14. Currently enrolled or recently participated (within the past 6 months) in a clinical trial of intranasal oxytocin.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 11 Years to 17 Years   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01931033
Other Study ID Numbers  ICMJE 2013-P-001548
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Gagan Joshi, Massachusetts General Hospital
Study Sponsor  ICMJE Massachusetts General Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Gagan Joshi, MD Massachusetts General Hospital
PRS Account Massachusetts General Hospital
Verification Date August 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP