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: November 4, 2012

Last verified: November 2012

History of Changes

Tracking Information
First Received Date ^ICMJE	March 3, 2010
Last Updated Date	November 4, 2012
Start Date ^ICMJE	December 2008
Primary Completion Date	July 2012 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: March 4, 2010)	Verbal and nonverbal behavior in therapy session [ Time Frame: videotapes of session will be reviewed and scored 1-3 months after the patient completes the study ] [ Designated as safety issue: No ] Videotapes of 2 therapy session (PBO/OT) will be reviewed by blinded raters to determine differences in two treatments.
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT01081249 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: March 4, 2010)	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.
Original Secondary Outcome Measures ^ICMJE	Same as current
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Effects of Oxytocin on Behavior and Physiology in a Psychotherapy Setting
Official Title ^ICMJE	Physiologic Correlates of Perceived [Therapist] Empathy and Social-Emotional Process During Psychotherapy: Testing Oxytocin in a Cross-Over Design Pilot Study
Brief 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.
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Phase 4
Study Design ^ICMJE	Allocation: Randomized Intervention Model: Crossover Assignment Masking: Double Blind (Subject, Investigator, Outcomes Assessor) Primary Purpose: Treatment
Condition ^ICMJE	Behavior Anxiety
Intervention ^ICMJE	Drug: intranasal oxytocin single dose of 40 IU intranasal oxytocin or similar volume of placebo Drug: placebo single dose of 40 IU intranasal oxytocin or similar volume of placebo
Study Arm (s)	Placebo Comparator: active drug placebo Interventions: Drug: intranasal oxytocin Drug: placebo
Publications *	Macdonald K, Macdonald TM. The peptide that binds: a systematic review of oxytocin and its prosocial effects in humans. Harv Rev Psychiatry. 2010;18(1):1-21.
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	18
Completion Date	July 2012
Primary Completion Date	July 2012 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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
Gender	Male
Ages	18 Years to 65 Years
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States

Administrative Information
NCT Number ^ICMJE	NCT01081249
Other Study ID Numbers ^ICMJE	UCSD IRB 080953
Has Data Monitoring Committee	No
Responsible Party	Kai MacDonald, MacDonald, Kai, M.D.
Study Sponsor ^ICMJE	MacDonald, Kai, M.D.
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	MacDonald, Kai, M.D.
Verification Date	November 2012
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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