NCT01081249

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
18

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Dec 2008

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2008

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

March 3, 2010

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 5, 2010

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2012

Completed
2.3 years until next milestone

Results Posted

Study results publicly available

October 16, 2014

Completed
Last Updated

October 16, 2014

Status Verified

October 1, 2014

Enrollment Period

3.6 years

First QC Date

March 3, 2010

Results QC Date

September 16, 2014

Last Update Submit

October 13, 2014

Conditions

BehaviorAnxiety

Keywords

psychotherapy

Outcome Measures

Primary Outcomes (1)

  • Verbal and Nonverbal Behavior in Therapy Session: Effects of Drug

    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.

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

Secondary Outcomes (3)

  • Salivary Cortisol

    before drug, before session, and 20 minutes after session

  • Heart Rate Variability (HRV)

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

  • Subjective Ratings of Anxiety and Trust of the Therapist

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

Study Arms (2)

Placebo then Oxytocin

EXPERIMENTAL

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

Oxytocin then placebo

EXPERIMENTAL

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

Interventions

Placebo then intranasal oxytocinDRUG

Participant received intranasal placebo spray at first psychotherapy session, and received a single dose of 40 IU intranasal oxytocin at the second session.

Placebo then Oxytocin
Intranasal oxytocin then placeboDRUG

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.

Oxytocin then placebo

Eligibility Criteria

Age18 Years - 65 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • in current mental health treatment
  • male 18-65

You may not qualify if:

  • diagnosis of schizophrenia or psychosis
  • diagnosis of autism or Aspergers disorder
  • active substance use disorder
  • at moderate or high risk of self-harm

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kai MacDonald, MD 3368 2nd Ave Ste B

San Diego, California, 92103, United States

Location

Related Publications (2)

  • Macdonald K, Macdonald TM. The peptide that binds: a systematic review of oxytocin and its prosocial effects in humans. Harv Rev Psychiatry. 2010 Jan-Feb;18(1):1-21. doi: 10.3109/10673220903523615.

    PMID: 20047458BACKGROUND

  • MacDonald K, MacDonald TM, Brune M, Lamb K, Wilson MP, Golshan S, Feifel D. Oxytocin and psychotherapy: a pilot study of its physiological, behavioral and subjective effects in males with depression. Psychoneuroendocrinology. 2013 Dec;38(12):2831-43. doi: 10.1016/j.psyneuen.2013.05.014. Epub 2013 Jun 28.

    PMID: 23810433DERIVED

MeSH Terms

Conditions

BehaviorAnxiety Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Results Point of Contact

Title
Dr. Kai MacDonald
Organization
University of California, San Diego Medical Center, Department of Psychiatry
619-203-7393

Study Officials

  • Kai MacDonald, MD

    UCSD

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDIV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant clinical professor

Study Record Dates

First Submitted

March 3, 2010

First Posted

March 5, 2010

Study Start

December 1, 2008

Primary Completion

July 1, 2012

Study Completion

July 1, 2012

Last Updated

October 16, 2014

Results First Posted

October 16, 2014

Record last verified: 2014-10

Locations

US(1)