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NCT01081249 · ClinicalTrials.gov registry record · Phase 4
Effects of Oxytocin on Behavior and Physiology in a Psychotherapy Setting
A Phase 4 study of Anxiety and Behavior, sponsored by MacDonald, Kai, M.D..
- Completed
- Registry status
- Phase 4
- Development phase
- 18
- Enrollment target
- 1
- Study location
NCT01081249: Completed Phase 4 study of Anxiety and Behavior, sponsored by MacDonald, Kai, M.D..
NCT01081249 is a Phase 4 study of Anxiety and Behavior that has completed, run by MacDonald, Kai, M.D.. The registered enrollment target is 18 participants, below the 440-participant average among 364 other Anxiety trials with a reported enrollment target (96% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01081249, a Phase 4 study of Anxiety and Behavior, has completed, sponsored by MacDonald, Kai, M.D..
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 18 participants
- Enrollment target
- 1
- Study location
Study Summary
Subjects-currently in outpatient mental health care--will participate in 2 psychotherapy sessions, one with oxytocin spray and one with placebo spray. Sessions will be videotaped, and cortisol and heart rate will be measured. We hypothesize that oxytocin will have positive benefits on nonverbal behavior in the therapy session, as well as have positive effects on subjective anxiety, cortisol and heart rate.
Primary Outcome
Videotapes of 2 therapy session (PBO/OT) were reviewed by blinded raters to determine differences in two treatments. There were nine aspects analyzed using the Ethological Coding System for Interviews: eye contact, affiliation, submission, prosocial, flight, assertion, displacement, relaxation, and gesture.
Interventions
- DRUG Placebo then intranasal oxytocin
- DRUG Intranasal oxytocin then placebo
Study Locations (1)
California
- Kai MacDonald, MD 3368 2nd Ave Ste B - San Diego
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 18 participants |
| Start Date | 2008-12 |
| Est. Completion | 2012-07 |
| Phase | Phase 4 |
What the finished NCT01081249 record still lists
NCT01081249 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 18 participants, a relatively small participant target, below the 440-participant average among 364 other Anxiety trials with a reported enrollment target (96% lower).
The record links to 2 conditions, with Anxiety appearing as the primary indexed condition, and to 2 interventions - of which Placebo then intranasal oxytocin is the first listed.
NCT01081249 reports a single indexed study location in California.
Frequently Asked Questions
What is clinical trial NCT01081249 about?
NCT01081249 is a clinical study titled "Effects of Oxytocin on Behavior and Physiology in a Psychotherapy Setting". Subjects-currently in outpatient mental health care--will participate in 2 psychotherapy sessions, one with oxytocin spray and one with placebo spray. Sessions will be videotaped, and cortisol and heart rate will be measured. We hypothesize that oxytocin will have positive benefits on nonverbal beha...
What is the current status of trial NCT01081249?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 18 participants. The study started on 2008-12. Estimated completion is 2012-07.
What conditions does trial NCT01081249 study?
This clinical trial studies the following conditions: Anxiety, Behavior.
What interventions are being tested in trial NCT01081249?
The interventions under investigation include: Placebo then intranasal oxytocin (DRUG), Intranasal oxytocin then placebo (DRUG).
Who is sponsoring clinical trial NCT01081249?
This trial is sponsored by MacDonald, Kai, M.D., which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01081249 being conducted?
This trial has 1 study location across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Anxiety
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT01081249's enrollment target sits among peer trials
18 334th of 364 higher than 27 of 364 other Anxiety trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Anxiety 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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