Trial · Interventional

CompletedPhase 4Results postedRegistry data

Effects of Oxytocin on Behavior and Physiology in a Psychotherapy Setting

Short name OT-PT

NCTNCT01081249Other idUCSD IRB 080953

Open at ClinicalTrials.govAsk about this trial

Overview

Status: Completed
Phase: Phase 4
Enrollment: 18 participants (actual)
Sponsor: MacDonald, Kai, M.D. · Indiv
Design: Randomized · Triple masking
Countries: 1 country
United States
Start: Dec 2008
Primary completion: Jul 2012
Completion: Jul 2012
First posted: 5 Mar 2010 (estimated)
Last update posted: 16 Oct 2014 (estimated)
Conditions: Behavior · Anxiety

Timeline

1 trial · 1 completed · 1 with posted results

Completed
Ongoing
Not yet recruiting
Stopped
Estimated dates (est.)
Results posted

200820092010201120122013

Ph 4
OT-PT
NCT01081249
Dec 2008 to Jul 2012

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

Placebo then intranasal oxytocinDrug
Intranasal oxytocin then placeboDrug

Arms2

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.
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.

Primary outcomes1

Outcomes the sponsor listed as primary.

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
Registry description
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 outcomes(3)

Salivary Cortisol
Time frame · before drug, before session, and 20 minutes after session
Registry description
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
Registry description
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
Registry description
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.

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

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

Verbal and Nonverbal Behavior in Therapy Session: Effects of Drug

Group	Value (Number of behaviors exhibited)	Spread
Placebo	34	2.2
Active Drug	34.8	2.4

Secondary and other outcome results(3)

Secondary outcome· before drug, before session, and 20 minutes after session

Salivary Cortisol

Group	Value

Secondary outcome· continuously monitored from time before drug delivery to 20 minutes after session

Heart Rate Variability (HRV)

Group	Value

Secondary outcome· measured before drug, immediately before session, and after the session

Subjective Ratings of Anxiety and Trust of the Therapist

Group	Value

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
Group	Deaths	Serious events	Other events
Placebo Then OxytocinParticipants received intranasal placebo spray prior to the first psychotherapy session; prior to the second psychotherapy session they received 40 IU intranasal oxytocin.	–	0 / 6	0 / 6
Oxytocin Then PlaceboParticipants 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

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies2

Studies that cite this trial.

Studies with results

2 studies on this page

Indexing hint: Randomized controlled trial · 2013

6 results

Oxytocin and psychotherapy: a pilot study of its physiological, behavioral and subjective effects in males with depression.

MacDonald et al. 2013Psychoneuroendocrinologycited by 108

PMID 23810433DOI 10.1016/j.psyneuen.2013.05.014PUB-23810433

Full text at the publisher6 results

Publisher page See results (6)

Indexing hint: Systematic review · 2010

1 result

The peptide that binds: a systematic review of oxytocin and its prosocial effects in humans.

Macdonald et al. 2010Harvard review of psychiatrycited by 364

PMID 20047458DOI 10.3109/10673220903523615PUB-20047458

Full text at the publisher1 result

Publisher page See results (1)

Eligibility

Who could join, as posted.

Sex: Male
Age: from 18 Years up to 65 Years
Healthy volunteers: Not accepted

Inclusion and exclusion criteria, as posted

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

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