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NCT02985749

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

Completed Phase 3 Results posted Last updated 1 July 2024
What this trial tests

Phase 3 trial testing Intranasal Oxytocin in Autism Spectrum Disorder in 7 participants. Completed in 9 January 2019.

Timeline
9 October 2017
Primary endpoint
9 January 2019
9 January 2019

Quick facts

Lead sponsorMassachusetts General Hospital
PhasePhase 3
StatusCompleted
Study typeINTERVENTIONAL
Allocationnon randomized
Designsingle group
Maskingnone
Primary purposetreatment
Enrollment7
Start date9 October 2017
Primary completion9 January 2019
Estimated completion9 January 2019
Sites1 location across United States

Drugs / interventions tested

Conditions studied

Sponsor

Massachusetts General Hospital

Who can join

Adults 12 to 55, any sex, with Autism Spectrum Disorder or Pervasive Developmental Disorder. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

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

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.

GroupValue95% CI
Oxytocin- Participants Ages 12-17-39.5± 12
Oxytocin- Participants Ages 18-55-29± 9.8

Adverse events — posted to ClinicalTrials.gov

Time frame: 8 weeks (from baseline to end of study). Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Oxytocin- Participants Ages 12-17
Serious: 0/2 (0%)
Deaths: 0/2
Oxytocin- Participants Ages 18-55
Serious: 0/5 (0%)
Deaths: 0/5
Other adverse events (7 terms — click to expand)

ReactionSystemOxytocin- Participants Age…Oxytocin- Participants Age…
Ear infectionEar and labyrinth disorders
Foot painMusculoskeletal and connective tissue disorders
Faint/dizzy after blood drawnNervous system disorders
DrowsinessNervous system disorders
AllergyImmune system disorders
Increased sex drivePsychiatric disorders
Joint painMusculoskeletal and connective tissue disorders

Data from ClinicalTrials.gov NCT02985749 adverse events section.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

  1. Social Skills Deficits in Autism Spectrum Disorder: Potential Biological Origins and Progress in Developing Therapeutic Agents.
    Frye RE. · · 2018 · cited 98× · PMID 30105528 · DOI 10.1007/s40263-018-0556-y

Verify or expand the search:

Other trials of Intranasal Oxytocin

Trials testing the same drug.

Other recruiting trials for Autism Spectrum Disorder

Currently open trials in the same condition.

Other Massachusetts General Hospital trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02985749.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing