Phase 4
N=18
Effects of Oxytocin on Behavior and Physiology in a Psychotherapy Setting
Behavior · Anxiety
Bottom Line
View on ClinicalTrials.gov: NCT01081249 ↗Enrolled (actual)
18
Serious AEs
0.0%
Results posted
Oct 2014
Primary outcome: Primary: Verbal and Nonverbal Behavior in Therapy Session: Effects of Drug — 34; 34.8; 45.4; 46.0 Number of behaviors exhibited
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Placebo then intranasal oxytocin (Drug); Intranasal oxytocin then placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Male
- Sponsor
- MacDonald, Kai, M.D.
- Primary completion
- Jul 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Verbal and Nonverbal Behavior in Therapy Session: Effects of Drug |
34; 34.8; 45.4; 46.0; 24.4; 25.14 | — |
| SECONDARY Salivary Cortisol |
— | — |
| SECONDARY Heart Rate Variability (HRV) |
— | — |
| SECONDARY Subjective Ratings of Anxiety and Trust of the Therapist |
— | — |
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.
Eligibility Criteria
Inclusion Criteria
- in current mental health treatment
- male 18-65
Exclusion Criteria
- diagnosis of schizophrenia or psychosis
- diagnosis of autism or Aspergers disorder
- active substance use disorder
- at moderate or high risk of self-harm
Data sourced from ClinicalTrials.gov (NCT01081249). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.