Trial Outcomes & Findings for Effects of Oxytocin on Behavior and Physiology in a Psychotherapy Setting (NCT NCT01081249)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

18 participants

Primary outcome timeframe

videotapes of session were reviewed and scored 1-3 months after the patient completes the study

Results posted on

2014-10-16

Participant Flow

Participant milestones

Participant milestones
Measure	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.	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.
Overall Study STARTED	11	7
Overall Study First Psychotherapy Appointment (1 Day)	11	6
Overall Study Washout (5-10 Days)	11	6
Overall Study Second Psychotherapy Appointment (1 Day)	11	6
Overall Study COMPLETED	11	6
Overall Study NOT COMPLETED	0	1

Reasons for withdrawal

Reasons for withdrawal
Measure	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.	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.
Overall Study Diagnosed with Bipolar Disorder	0	1

Baseline Characteristics

Effects of Oxytocin on Behavior and Physiology in a Psychotherapy Setting

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Active Drug n=17 Participants 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
Age, Categorical <=18 years	0 Participants n=93 Participants
Age, Categorical Between 18 and 65 years	17 Participants n=93 Participants
Age, Categorical >=65 years	0 Participants n=93 Participants
Sex: Female, Male Female	0 Participants n=93 Participants
Sex: Female, Male Male	17 Participants n=93 Participants
Region of Enrollment United States	17 participants n=93 Participants

PRIMARY outcome

Timeframe: videotapes of session were reviewed and scored 1-3 months after the patient completes the study

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.

Outcome measures

Outcome measures
Measure	Placebo n=17 Participants A dose of intranasal placebo was administered prior to the psychotherapy session.	Active Drug n=17 Participants A dose of 40 IU intranasal oxytocin was administered prior to the psychotherapy session.
Verbal and Nonverbal Behavior in Therapy Session: Effects of Drug ECSI eye contact	34 Number of behaviors exhibited Standard Deviation 2.2	34.8 Number of behaviors exhibited Standard Deviation 2.4
Verbal and Nonverbal Behavior in Therapy Session: Effects of Drug ECSI affiliation	45.4 Number of behaviors exhibited Standard Deviation 5.1	46.0 Number of behaviors exhibited Standard Deviation 4.5
Verbal and Nonverbal Behavior in Therapy Session: Effects of Drug ECSI submission	24.4 Number of behaviors exhibited Standard Deviation 6.1	25.14 Number of behaviors exhibited Standard Deviation 5.6
Verbal and Nonverbal Behavior in Therapy Session: Effects of Drug ECSI prosocial	69.8 Number of behaviors exhibited Standard Deviation 7.3	71.1 Number of behaviors exhibited Standard Deviation 7.3
Verbal and Nonverbal Behavior in Therapy Session: Effects of Drug ECSI flight	65.7 Number of behaviors exhibited Standard Deviation 2.9	61.1 Number of behaviors exhibited Standard Deviation 4.0
Verbal and Nonverbal Behavior in Therapy Session: Effects of Drug ECSI assertion	30.5 Number of behaviors exhibited Standard Deviation 5.7	26.6 Number of behaviors exhibited Standard Deviation 3.9
Verbal and Nonverbal Behavior in Therapy Session: Effects of Drug ECSI displacement	46.6 Number of behaviors exhibited Standard Deviation 3.9	41.6 Number of behaviors exhibited Standard Deviation 5.2
Verbal and Nonverbal Behavior in Therapy Session: Effects of Drug ECSI relaxation	19.4 Number of behaviors exhibited Standard Deviation 4.4	18.7 Number of behaviors exhibited Standard Deviation 3.3
Verbal and Nonverbal Behavior in Therapy Session: Effects of Drug ECSI gesture	28.8 Number of behaviors exhibited Standard Deviation 3.0	29.3 Number of behaviors exhibited Standard Deviation 2.2

SECONDARY outcome

Timeframe: before drug, before session, and 20 minutes after session

Salivary cortisol will be measured after the treatment, and before, during and after the therapy session.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: continuously monitored from time before drug delivery to 20 minutes after session

HRV will be measured before, during and after the therapy session.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: measured before drug, immediately before session, and after the session

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.

Outcome measures

Outcome data not reported

Adverse Events

Placebo Then Oxytocin

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Oxytocin Then Placebo

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Kai MacDonald

University of California, San Diego Medical Center, Department of Psychiatry

Phone: 619-203-7393

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place