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NCT01624194 · ClinicalTrials.gov registry record · Phase 2

Intranasal Oxytocin Treatment for Social Deficits in Children With Autism

A Phase 2 study, sponsored by Stanford University.

Completed
Registry status
Phase 2
Development phase
54
Enrollment target

NCT01624194: Completed Phase 2 study, sponsored by Stanford University.

NCT01624194 is a Phase 2 study that has completed, run by Stanford University. The registered enrollment target is 54 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (59% lower). According to ClinicalTrials.gov, the official US trial registry.

View on ClinicalTrials.gov ↗

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The verdict

NCT01624194, a Phase 2 study, has completed, sponsored by Stanford University.

COMPLETED
Registry status
Phase 2
Development phase
54 participants
Enrollment target

Study Summary

Autism is a pervasive developmental disorder characterized by core deficits in social behavior and communication, and the presence of repetitive or stereotyped behaviors. It is one of three recognized disorders in the autism spectrum which affects an estimated 1 in 88 children in the United States. At present, pharmacotherapies target only associated features of autism, with no effective drug treatments for the social impairments. Several lines of evidence now suggest that the neuropeptide oxytocin (OT) may be an effective treatment for the core social deficits in autism. Here we will test the effects of twice daily intranasal OT (24 IU) over a 4-week period for enhancing social deficits in male and female children aged 6-12 years with autism. This research has high potential to lead to the development of more effective treatments and earlier interventions for children with autism.

Primary Outcome

Social Responsiveness Scale (SRS) raw scores measure social abilities with lower raw scores meaning better social abilities. (Raw Score Range: 0 - 195)

Interventions

  • DRUG Placebo
  • DRUG Oxytocin nasal spray

Trial Details

FieldValue
Enrollment Target 54 participants
Start Date 2012-06
Est. Completion 2016-05
Phase Phase 2
Stanford University

1,744 total trials

What the finished NCT01624194 record still lists

NCT01624194 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 54 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (59% lower).

The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.

NCT01624194 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT01624194 about?

NCT01624194 is a clinical study titled "Intranasal Oxytocin Treatment for Social Deficits in Children With Autism". Autism is a pervasive developmental disorder characterized by core deficits in social behavior and communication, and the presence of repetitive or stereotyped behaviors. It is one of three recognized disorders in the autism spectrum which affects an estimated 1 in 88 children in the United States. ...

What is the current status of trial NCT01624194?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 54 participants. The study started on 2012-06. Estimated completion is 2016-05.

What interventions are being tested in trial NCT01624194?

The interventions under investigation include: Placebo (DRUG), Oxytocin nasal spray (DRUG).

Who is sponsoring clinical trial NCT01624194?

This trial is sponsored by Stanford University, which has 1,744 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT01624194's enrollment target sits among peer trials

54 1160th of 2000 higher than 830 of 2,000 other Phase 2 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT01624194, the US trial registry maintained by the National Library of Medicine. NCT01624194 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.