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Effects of Oxytocin on Behavior and Physiology in a Psychotherapy Setting (OT-PT)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Kai MacDonald, MacDonald, Kai, M.D.
ClinicalTrials.gov Identifier:
NCT01081249
First received: March 3, 2010
Last updated: October 13, 2014
Last verified: October 2014
  Purpose

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.


Condition Intervention Phase
Behavior
Anxiety
Drug: Placebo then intranasal oxytocin
Drug: Intranasal oxytocin then placebo
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Physiologic Correlates of Perceived [Therapist] Empathy and Social-Emotional Process During Psychotherapy: Testing Oxytocin in a Cross-Over Design Pilot Study

Resource links provided by NLM:


Further study details as provided by MacDonald, Kai, M.D.:

Primary Outcome Measures:
  • Verbal and Nonverbal Behavior in Therapy Session: Effects of Drug [ Time Frame: videotapes of session were reviewed and scored 1-3 months after the patient completes the study ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Salivary Cortisol [ Time Frame: before drug, before session, and 20 minutes after session ] [ Designated as safety issue: No ]
    Salivary cortisol will be measured after the treatment, and before, during and after the therapy session.

  • Heart Rate Variability (HRV) [ Time Frame: continuously monitored from time before drug delivery to 20 minutes after session ] [ Designated as safety issue: No ]
    HRV will be measured before, during and after the therapy session.

  • Subjective Ratings of Anxiety and Trust of the Therapist [ Time Frame: measured before drug, immediately before session, and after the session ] [ Designated as safety issue: No ]
    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.


Enrollment: 18
Study Start Date: December 2008
Study Completion Date: July 2012
Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Placebo then Oxytocin
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 received intranasal placebo spray at first psychotherapy session, and received a single dose of 40 IU intranasal oxytocin at the second session.
Experimental: Oxytocin then placebo
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 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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01081249

Locations
United States, California
Kai MacDonald, MD 3368 2nd Ave Ste B
San Diego, California, United States, 92103
Sponsors and Collaborators
MacDonald, Kai, M.D.
Investigators
Principal Investigator: Kai MacDonald, MD UCSD
  More Information

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Kai MacDonald, Assistant clinical professor, MacDonald, Kai, M.D.
ClinicalTrials.gov Identifier: NCT01081249     History of Changes
Other Study ID Numbers: UCSD IRB 080953
Study First Received: March 3, 2010
Results First Received: September 16, 2014
Last Updated: October 13, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by MacDonald, Kai, M.D.:
psychotherapy

Additional relevant MeSH terms:
Oxytocin
Oxytocics
Pharmacologic Actions
Physiological Effects of Drugs
Reproductive Control Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on November 24, 2014