N/A
N=8
An Open-Label Trial of Oxytocin in Adolescents With Autism Spectrum Disorders
Autism Spectrum Disorders · Pervasive Developmental Disorders · ASD · PDD
Bottom Line
View on ClinicalTrials.gov: NCT01931033 ↗Enrolled (actual)
8
Serious AEs
0.0%
Results posted
Oct 2023
Primary outcome: Primary: Change in ASD Symptoms Social Responsiveness Scales 2 (SRS-2) Scales From Baseline to Week 8 — -32.4 scores on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Intranasal Oxytocin (Drug)
- Age
- Pediatric · 11+ yrs
- Sex
- All
- Sponsor
- Massachusetts General Hospital
- Primary completion
- Feb 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in ASD Symptoms Social Responsiveness Scales 2 (SRS-2) Scales From Baseline to Week 8 |
-32.4 | — |
| PRIMARY Number of Participants With ≥30% Reduction in SRS Raw Score and CGI Improvement Scores of ≤ 2 at Week 8 |
2 | — |
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.
Eligibility Criteria
Inclusion Criteria
- Male and female outpatients ages 11-17 years
- 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).
- 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.
- 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.
- Each subject and their parent/guardian must understand the nature of the study and provide written informed assent/consent.
- Subjects must be able to participate in mandatory blood draws.
- 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
- IQ 3 times ULN) and those with severely impaired renal function (eGFR < 30).
- 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).
- 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.
Data sourced from ClinicalTrials.gov (NCT01931033). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.