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COMPLETED Phase 4

Effects of Oxytocin on Behavior and Physiology in a Psychotherapy Setting

NCT01081249 · View on ClinicalTrials.gov ↗

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.

Conditions Studied

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

FieldValue
Enrollment Target 18 participants
Start Date 2008-12
Est. Completion 2012-07
Phase Phase 4

Sponsor

MacDonald, Kai, M.D.

1 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT01081249

The ClinicalTrials.gov registry entry for NCT01081249 describes a study currently listed as completed. It is categorized as Phase 4, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 18 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is MacDonald, Kai, M.D., which has 1 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT01081249 reports 1 study location spanning 1 distinct geographic area — top geographies include California. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT01081249?

The interventions under investigation include: Placebo then intranasal oxytocin (DRUG), Intranasal oxytocin then placebo (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

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. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial