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

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

Tracking Information

• First Submitted Date: August 22, 2013
• First Posted Date: August 29, 2013
• Last Update Posted Date: August 25, 2020
• Study Start Date: October 2013
• Estimated Primary Completion Date: June 2021 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (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: Same as current

Current Secondary Outcome Measures (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: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: An Open-Label Trial of Oxytocin in Adolescents With Autism Spectrum Disorders
• Official Title: 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: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment

Condition

• Autism Spectrum Disorders
• Pervasive Developmental Disorders
• ASD
• PDD

Intervention

Drug: Intranasal Oxytocin

Other Name: Syntocinon

Study Arms

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

Recruitment Information

• Recruitment Status: Active, not recruiting
• Estimated Enrollment (submitted: August 26, 2013): 40
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: June 2021
• Estimated Primary Completion Date: June 2021 (Final data collection date for primary outcome measure)

Eligibility Criteria

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

• Sexes Eligible for Study: All

• Ages: 11 Years to 17 Years (Child)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT01931033
• Other Study ID Numbers: 2013-P-001548
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Gagan Joshi, Massachusetts General Hospital
• Study Sponsor: Massachusetts General Hospital
• Collaborators: Not Provided

Investigators

• Principal Investigator: Gagan Joshi, MD; Massachusetts General Hospital

• PRS Account: Massachusetts General Hospital
• Verification Date: August 2020