Clinical trial NCT02985749: A Study of Oxytocin for the Treatment of Social Impairment in Individuals With High Functioning Autism Spectrum Disorder
Official title: A Pilot Study of Oxytocin for the Treatment of Social Impairment in Individuals With High Functioning Autism Spectrum Disorder
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Autism Spectrum Disorder
Pervasive Developmental Disorder
ASD
PDD
Keywords: Autism Spectrum Disorders
Pervasive Developmental Disorder
ASD
PDD
Oxytocin
Syntocinon
Social Impairment
Treatment
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
First posted: 2016-12-07
Enrollment: 7
Sex: ALL
Minimum age (years): 12
Maximum age (years): 55
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study is an 8-week pilot trial with oxytocin nasal spray (Syntocinon) as a treatment for social impairment in children and adults with high functioning autism spectrum disorders (ASD). The investigators hypothesize that oxytocin will be safe, tolerable, and effective in improving social deficits in individuals with ASD.


Eligibility criteria: Inclusion Criteria:

* Males and females between 12 and 55 years of age.
* Meets the DSM-5 diagnostic criteria for Autism Spectrum Disorder (ASD) as established by clinical diagnostic interview
* At least moderate severity of ASD impairment as measured by a raw score of ≥85 on the SRS
* 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.
* Subjects and their parent/guardian must be considered reliable reporters. They must understand the nature of the study and must sign an IRB-approved informed consent form before initiation of any study procedures. Subjects and their parent/guardian must have a level of understanding sufficient to communicate with the investigator and study coordinator, and to cooperate with all tests and examinations required by the protocol.
* Each subject and their parent/guardian must understand the nature of the study and provide written informed assent/consent.
* Subjects with mood, anxiety, or disruptive behavior disorders will be allowed to participate in the study provided they do not meet any exclusionary criteria.
* If the subject is sexually active, he/she must agree to use an acceptable form of birth control during the study. These include:
* Abstinence (no sexual contact)
* A barrier method (diaphragm plus spermicide or a condom plus spermicide) in addition to one of the following methods:
* Consistent use of an approved birth control pill
* Birth control patch
* Injected contraceptives
* Intrauterine device (IUD)

Exclusion Criteria:

* Impaired intellectual functioning and/or impaired spoken language.
* Clinically unstable psychiatric conditions or any serious medical illness, which will be assessed by study clinicians during the psychiatric interview and medical history review. If the clinical assessment suggests a psychiatric or medical condition demanding acute clinical attention, then the subject will be excluded from participating in the trial.
* Clinically unstable psychiatric conditions.
* Any serious medical illness
* Pregnant or nursing females.
* Known hypersensitivity to oxytocin.
* Severe allergies or multiple adverse drug reactions.
* A non-responder or history of intolerance to oxytocin, after treatment at adequate doses as determined by the clinician.
* Subjects with significant nasal pathology (including atrophic rhinitis, recurrent nose bleeds, and history of hypophysectomy).
* Clinically abnormal baseline laboratory values falling significantly outside of the standard reference ranges for a basic metabolic screen.
* Investigator and his/her immediate family defined as the investigator's spouse, parent, child, grandparent, or grandchild.
* Currently enrolled or recently participated (within the past 6 months) in a clinical trial of intranasal oxytocin.

Primary outcomes:
measure: Change in ASD Symptoms Social Responsiveness Scale 2 (SRS-2) Scale From Baseline to Week 8
timeFrame: 8 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Cambridge
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
Study officials:
affiliation: Massachusetts General Hospital
name: Gagan Joshi, MD
role: PRINCIPAL_INVESTIGATOR
References: