CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 18 enrolled
Drug / intervention
Placebo then intranasal oxytocin +1 moredrug
Likely dose
Placebo then intranasal oxytocin 40 IUfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01081249
NCT01081249Phase 4Completed

Physiologic Correlates of Perceived [Therapist] Empathy and Social-Emotional Process During Psychotherapy: Testing Oxytocin in a Cross-Over Design Pilot Study

MacDonald, Kai, M.D.·interventional·Posted Mar 5, 2010·Updated Oct 16, 2014

In Brief

A Phase 4 clinical trial evaluating Placebo then intranasal oxytocin and Intranasal oxytocin then placebo for Behavior and Anxiety. Completed, enrolled 18 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsBehavior, Anxiety
CountriesUnited States
Collaborators--

Timeline

Phase 4CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedMar 5, 2010
Enrollment StartDec 1, 2008
Primary CompletionJul 1, 2012
TodayJul 2, 2026
Enrollment to primary: 3.6 yearsPosted 16.3 years ago

Interventions

Placebo then intranasal oxytocindrug

Participant received intranasal placebo spray at first psychotherapy session, and received a single dose of 40 IU intranasal oxytocin at the second session.

Intranasal oxytocin then placebodrug

Participant received a single dose of 40 IU intranasal oxytocin at the first psychotherapy session, and received a similar dose of intranasal placebo spray at the second session.