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NCT01914939 · ClinicalTrials.gov registry record · Phase 2
A Randomized, Controlled Trial of Intranasal Oxytocin as an Adjunct to Behavioral Therapy for Autism Spectrum Disorder
A Phase 2 study, sponsored by Massachusetts General Hospital.
- Completed
- Registry status
- Phase 2
- Development phase
- 92
- Enrollment target
NCT01914939: Completed Phase 2 study, sponsored by Massachusetts General Hospital.
NCT01914939 is a Phase 2 study that has completed, run by Massachusetts General Hospital. The registered enrollment target is 92 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (31% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01914939, a Phase 2 study, has completed, sponsored by Massachusetts General Hospital.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 92 participants
- Enrollment target
Study Summary
This 3-year study is a trial of cognitive behavioral therapy (CBT), with or without oxytocin (OT) augmentation, in young adults with autism spectrum disorders. Participants will be randomly assigned to receive either a social skills-focused CBT intervention or a stress management/relaxation training CBT intervention. Participants will also be randomized to receive either a) intranasal oxytocin or b) a placebo drug, prior to the psychotherapy. The design of the study will enable examination of the efficacy of CBT for young adults with autism spectrum disorders. The design of the study will also allow examination of whether oxytocin enhances the efficacy of CBT. The investigators will perform functional (fMRI) and structural (MRI) imaging with all participants prior to treatment. This will enable examination of the relations between measures of brain function and structure, and improvements in target symptoms over the course of treatment. The aim is to discover whether there are neural characteristics that can identify which participants with autism spectrum disorders are most likely to respond to CBT interventions and/or oxytocin treatment.
Primary Outcome
The ADOS is a semi-structured standardized assessment of communication and social interaction that is considered a gold-standard assessment of autism spectrum disorders. The study will use Module 4, designed for use with adolescents and adults. The primary endpoint(dependent measure) will be the change in a global impression of social engagement by a clinician who is an experienced ADOS administrator. This will be a rating on a 10-point scale and involve expert clinical judgement of the qualitie
Interventions
- DRUG Oxytocin
- BEHAVIORAL Social Skills focused CBT
- BEHAVIORAL Stress management/relaxation training
- DRUG placebo drug
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 92 participants |
| Start Date | 2014-04 |
| Est. Completion | 2017-11 |
| Phase | Phase 2 |
What the finished NCT01914939 record still lists
NCT01914939 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 92 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (31% lower).
The record links to 0 conditions, and to 4 interventions - of which Oxytocin is the first listed.
NCT01914939 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01914939 about?
NCT01914939 is a clinical study titled "A Randomized, Controlled Trial of Intranasal Oxytocin as an Adjunct to Behavioral Therapy for Autism Spectrum Disorder". This 3-year study is a trial of cognitive behavioral therapy (CBT), with or without oxytocin (OT) augmentation, in young adults with autism spectrum disorders. Participants will be randomly assigned to receive either a social skills-focused CBT intervention or a stress management/relaxation training...
What is the current status of trial NCT01914939?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 92 participants. The study started on 2014-04. Estimated completion is 2017-11.
What interventions are being tested in trial NCT01914939?
The interventions under investigation include: Oxytocin (DRUG), Social Skills focused CBT (BEHAVIORAL), Stress management/relaxation training (BEHAVIORAL), placebo drug (DRUG).
Who is sponsoring clinical trial NCT01914939?
This trial is sponsored by Massachusetts General Hospital, which has 2,032 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01914939's enrollment target sits among peer trials
92 767th of 2000 higher than 1,230 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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