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Trial · Interventional

CompletedNot applicableResults postedRegistry data

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

NCTNCT01931033 (opens ClinicalTrials.gov in a new tab)Other id2013-P-001548
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Completed
Phase
Not applicable
Enrollment
8 participants (actual)
Sponsor
Massachusetts General Hospital · Other
Design
Allocation not applicable · Open label (no masking)
Countries
1 country

United States

Start
Oct 2013
Primary completion
22 Feb 2016
Completion
22 Feb 2016
First posted
29 Aug 2013 (estimated)
Last update posted
1 Jul 2024
Conditions
Autism Spectrum Disorders · Pervasive Developmental Disorders · ASD · PDD

Timeline

1 trial · 1 completed · 1 with posted results

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
20132014201520162017
  1. N/A

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

    NCT01931033

    Oct 2013 to 22 Feb 2016

Registry summary

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

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.

Interventions

  • Intranasal OxytocinDrug

Arms1

  • Experimental

    Oxytocin

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

Primary outcomes2

Outcomes the sponsor listed as primary.

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

    Time frame · Week-8

    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.

  2. Number of Participants With ≥30% Reduction in SRS Raw Score and CGI Improvement Scores of ≤ 2 at Week 8

    Time frame · Week-8

    Registry description

    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. The Clinical Global Impression Improvement scale (CGI-ASD-I) is a clinician rated measure of ASD improvement. Improvement scores range from 1 (very much improved) to 7 (very much worse).

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· Week-8

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

GroupValue (scores on a scale)Spread
Participants Ages 11-17-32.417.25688
Primary outcomeCount of participants· Week-8

Number of Participants With ≥30% Reduction in SRS Raw Score and CGI Improvement Scores of ≤ 2 at Week 8

GroupValue (Participants)
Participants Ages 11-172

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
GroupDeathsSerious eventsOther events
Participants Ages 11-17Participants ages 11-17 enrolled to receive oxytocin treatment–0 / 85 / 8

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 11 Years up to 17 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
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.

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