A Phase 4 interventional study of Placebo then intranasal oxytocin and Intranasal oxytocin then placebo in Behavior and Anxiety, sponsored by MacDonald, Kai, M.D.. Completed at 1 site in United States. Open to male participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2014-10-16.
Sponsored by MacDonald, Kai, M.D. · Phase 4, Interventional, and Treatment
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.
MacDonald, Kai, M.D. is the lead sponsor of 2 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Participant was randomized to receive placebo before the first psychotherapy session, and then received the active drug at the second visit.
Drug: Placebo then intranasal oxytocin
Participant was randomized to receive placebo before the first psychotherapy session, and then received the active drug at the second visit.
Drug: Intranasal oxytocin then placebo
Participant received intranasal placebo spray at first psychotherapy session, and received a single dose of 40 IU intranasal oxytocin at the second session.
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.
Verbal and Nonverbal Behavior in Therapy Session: Effects of Drug
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.
Time frame: videotapes of session were reviewed and scored 1-3 months after the patient completes the study
Salivary Cortisol
Salivary cortisol will be measured after the treatment, and before, during and after the therapy session.
Time frame: before drug, before session, and 20 minutes after session
Heart Rate Variability (HRV)
HRV will be measured before, during and after the therapy session.
Time frame: continuously monitored from time before drug delivery to 20 minutes after session
Subjective Ratings of Anxiety and Trust of the Therapist
Patient will fill out ratings of subjective anxiety (STAI), mood and energy (PANAS), and trust (Likert scale) in the therapist before and after the session.
Time frame: measured before drug, immediately before session, and after the session
| Milestone | Oxytocin Then Placebo | Placebo Then Oxytocin |
|---|---|---|
| Started | 11 | 7 |
| First psychotherapy appointment (1 day) | 11 | 6 |
| Washout (5-10 days) | 11 | 6 |
| Second psychotherapy appointment (1 day) | 11 | 6 |
| Completed | 11 | 6 |
| Not completed | 0 | 1 |
| Withdrew: Diagnosed with bipolar disorder | 0 | 1 |
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.
| Number of behaviors exhibited | Placebo | Active Drug |
|---|---|---|
| ECSI eye contact | 34 ± 2.2 | 34.8 ± 2.4 |
| ECSI affiliation | 45.4 ± 5.1 | 46.0 ± 4.5 |
| ECSI submission | 24.4 ± 6.1 | 25.14 ± 5.6 |
| ECSI prosocial | 69.8 ± 7.3 | 71.1 ± 7.3 |
| ECSI flight | 65.7 ± 2.9 | 61.1 ± 4.0 |
| ECSI assertion | 30.5 ± 5.7 | 26.6 ± 3.9 |
| ECSI displacement | 46.6 ± 3.9 | 41.6 ± 5.2 |
| ECSI relaxation | 19.4 ± 4.4 | 18.7 ± 3.3 |
| ECSI gesture | 28.8 ± 3.0 | 29.3 ± 2.2 |
Salivary cortisol will be measured after the treatment, and before, during and after the therapy session.
Results for this outcome have not been posted.
HRV will be measured before, during and after the therapy session.
Results for this outcome have not been posted.
Patient will fill out ratings of subjective anxiety (STAI), mood and energy (PANAS), and trust (Likert scale) in the therapist before and after the session.
Results for this outcome have not been posted.
Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Placebo Then Oxytocin | — | 0/6 (0%) | 0/6 (0%) |
| Oxytocin Then Placebo | — | 0/11 (0%) | 0/11 (0%) |
| Age, Categorical(Participants) | Active Drug |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 17 |
| >=65 years | 0 |
| Sex: Female, Male(Participants) | Active Drug |
|---|---|
| Female | 0 |
| Male | 17 |
| Region of Enrollment(participants) | Active Drug |
|---|---|
| United States | 17 |
This study is completed, as verified in Oct 2014. You cannot join it, but the record below documents what was studied.
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MacDonald, Kai, M.D.