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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. 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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01914939
The ClinicalTrials.gov registry entry for NCT01914939 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 92 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Massachusetts General Hospital, which has 2,032 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 4 interventions - of which Oxytocin is the first listed.
NCT01914939 reports 0 study locations.
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.
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