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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo then Oxytocin | Experimental | Participant was randomized to receive placebo before the first psychotherapy session, and then received the active drug at the second visit. |
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| Oxytocin then placebo | Experimental | Participant was randomized to receive placebo before the first psychotherapy session, and then received the active drug at the second visit. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo then intranasal oxytocin | Drug | Participant received intranasal placebo spray at first psychotherapy session, and received a single dose of 40 IU intranasal oxytocin at the second session. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | videotapes of session were reviewed and scored 1-3 months after the patient completes the study |
| Measure | Description | Time Frame |
|---|---|---|
| Salivary Cortisol | Salivary cortisol will be measured after the treatment, and before, during and after the therapy session. | before drug, before session, and 20 minutes after session |
| Heart Rate Variability (HRV) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kai MacDonald, MD | UCSD | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kai MacDonald, MD 3368 2nd Ave Ste B | San Diego | California | 92103 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20047458 | Background | Macdonald K, Macdonald TM. The peptide that binds: a systematic review of oxytocin and its prosocial effects in humans. Harv Rev Psychiatry. 2010 Jan-Feb;18(1):1-21. doi: 10.3109/10673220903523615. | |
| 23810433 | Derived | MacDonald K, MacDonald TM, Brune M, Lamb K, Wilson MP, Golshan S, Feifel D. Oxytocin and psychotherapy: a pilot study of its physiological, behavioral and subjective effects in males with depression. Psychoneuroendocrinology. 2013 Dec;38(12):2831-43. doi: 10.1016/j.psyneuen.2013.05.014. Epub 2013 Jun 28. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Oxytocin Then Placebo | Participants received a single dose of 40 IU intranasal oxytocin prior to the first psychotherapy session; prior to the second psychotherapy session they received a similar dose of intranasal placebo. |
| FG001 | Placebo Then Oxytocin | Participants received a single dose of intranasal placebo prior to the first psychotherapy session; prior to the second psychotherapy session the participants received a single dose of 40 IU intranasal oxytocin. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Active Drug | placebo intranasal oxytocin: single dose of 40 IU intranasal oxytocin or similar volume of placebo placebo: single dose of 40 IU intranasal oxytocin or similar volume of placebo |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Mean | Standard Deviation | Number of behaviors exhibited | videotapes of session were reviewed and scored 1-3 months after the patient completes the study |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Placebo Then Oxytocin | Participants received intranasal placebo spray prior to the first psychotherapy session; prior to the second psychotherapy session they received 40 IU intranasal oxytocin. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Kai MacDonald | University of California, San Diego Medical Center, Department of Psychiatry | 619-203-7393 |
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| ID | Term |
|---|---|
| D001519 | Behavior |
| D001008 | Anxiety Disorders |
| ID | Term |
|---|---|
| D001523 | Mental Disorders |
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| Intranasal oxytocin then placebo | Drug | 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. |
|
HRV will be measured before, during and after the therapy session.
| 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. | measured before drug, immediately before session, and after the session |
| Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Secondary | Salivary Cortisol | Salivary cortisol will be measured after the treatment, and before, during and after the therapy session. | Not Posted | before drug, before session, and 20 minutes after session |
| Secondary | Heart Rate Variability (HRV) | HRV will be measured before, during and after the therapy session. | Not Posted | continuously monitored from time before drug delivery to 20 minutes after session |
| Secondary | 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. | Not Posted | measured before drug, immediately before session, and after the session |
| 0 |
| 6 |
| 0 |
| 6 |
| EG001 | Oxytocin Then Placebo | Participants received 40 IU intranasal oxytocin prior to the first psychotherapy session; prior to the second psychotherapy session they received a comparable dose of intranasal placebo spray. | 0 | 11 | 0 | 11 |
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