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Trial · Interventional

CompletedPhase 3Results postedRegistry data

A Study of Oxytocin for the Treatment of Social Impairment in Individuals With High Functioning Autism Spectrum Disorder

Overview

Status
Completed
Phase
Phase 3
Enrollment
7 participants (actual)
Sponsor
Massachusetts General Hospital · Other
Design
Not randomized · Open label (no masking)
Countries
1 country

United States

Start
9 Oct 2017
Primary completion
9 Jan 2019
Completion
9 Jan 2019
First posted
7 Dec 2016 (estimated)
Last update posted
1 Jul 2024
Conditions
Autism Spectrum Disorder · Pervasive Developmental Disorder · ASD · PDD

Timeline

1 trial · 1 completed · 1 with posted results

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
2017201820192020
  1. Ph 3

    A Study of Oxytocin for the Treatment of Social Impairment in Individuals With High Functioning Autism Spectrum Disorder

    NCT02985749

    9 Oct 2017 to 9 Jan 2019

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

  • Intranasal OxytocinDrug

Arms2

  • Experimental

    Oxytocin- Participants ages 12-17

    Intranasal Oxytocin (brand name Syntocinon) will be administered daily (for a total daily dose of 48 IU) for 8 weeks.

  • Experimental

    Oxytocin- Participants ages 18-55

    Intranasal Oxytocin (brand name Syntocinon) will be administered daily (for a total daily dose of 48 IU) for 8 weeks.

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Change in ASD Symptoms Social Responsiveness Scale 2 (SRS-2) Scale From Baseline to Week 8

    Time frame · 8 weeks

    Registry description

    Change in ASD symptoms as measured by change from baseline on the Social Responsiveness Scale 2 (SRS-2) scale. The SRS-2 is a 65-item rating scale completed that is used to measure the severity of autism spectrum symptoms as they occur in natural settings. The SRS-2 School Age form is completed by a parent or guardian for patients ages 9-17 and the SRS-2 Adult Self-report is completed by patients ages 18-59. Total raw scores range from 0 to 195, with higher scores indicating increased symptom severity.

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeMean· 8 weeks

Change in ASD Symptoms Social Responsiveness Scale 2 (SRS-2) Scale From Baseline to Week 8

GroupValue (scores on a scale)Spread
Oxytocin- Participants Ages 12-17-39.512
Oxytocin- Participants Ages 18-55-299.8

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
GroupDeathsSerious eventsOther events
Oxytocin- Participants Ages 12-17Participants ages 12-17 enrolled to receive oxytocin treatment Intranasal Oxytocin (brand name Syntocinon) will be administered daily (for a total daily dose of 48 IU) for 8 weeks. Intranasal Oxytocin: This study is examining the short-term efficacy and tolerability of intranasal oxytocin for the treatment of social impairment in youths and adults with high-functioning ASD (HF-ASD).0 / 20 / 21 / 2
Oxytocin- Participants Ages 18-55Participants ages 18-55 enrolled to receive oxytocin treatment Intranasal Oxytocin (brand name Syntocinon) will be administered daily (for a total daily dose of 48 IU) for 8 weeks. Intranasal Oxytocin: This study is examining the short-term efficacy and tolerability of intranasal oxytocin for the treatment of social impairment in youths and adults with high-functioning ASD (HF-ASD).0 / 50 / 53 / 5

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex
All
Age
from 12 Years up to 55 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
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.

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