BehaviorPhase 4OT-PTNCT01081249

Effects of Oxytocin on Behavior and Physiology in a Psychotherapy Setting

A Phase 4 study of Behavior and Anxiety, run by MacDonald, Kai, M.D. at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 to 65 years, men only
Conditions the study is for: Behavior, Anxiety
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 18 participants
Where: 1 siteUnited States
Study dates: Dec 2008to Jul 2012
Phase: Phase 4
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 65 years
Men only
No healthy volunteers
Adult, Older adult

Who may be able to join

in current mental health treatment
male 18-65

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

United States1 site

Kai MacDonald, MD 3368 2nd Ave Ste B
San Diego, California, 92103

Other trials in United States

About this study

Official title: Physiologic Correlates of Perceived [Therapist] Empathy and Social-Emotional Process During Psychotherapy: Testing Oxytocin in a Cross-Over Design Pilot Study

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.

Conditions: Behavior, Anxiety
Being tested: Placebo then intranasal oxytocin, Intranasal oxytocin then placebo
Keywords: psychotherapy
Medical subject headings: Behavior, Anxiety Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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.
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.

Study groups in NCT01081249
Study group	Role	What they receive
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. Receives: 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. Receives: Drug: Intranasal oxytocin then placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

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

Secondary outcomes (3)

Salivary Cortisol
Salivary cortisol will be measured after the treatment, and before, during and after the therapy session.
Measured: before drug, before session, and 20 minutes after session
Heart Rate Variability (HRV)
HRV will be measured before, during and after the therapy session.
Measured: continuously monitored from time before drug delivery to 20 minutes after session
Subjective Ratings of Anxiety and Trust of the Therapist
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.
Measured: measured before drug, immediately before session, and after the session

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Dec 2008Jul 2012

First posted5 Mar 2010 (estimated)
Study startDec 2008
Primary completionJul 2012
Study completionJul 2012

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (2)Papers the sponsor has linked to this study.
Other trials for BehaviorStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 4
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Triple blind
Who is masked: Participant, Investigator, Outcomes assessor
Enrolment: 18 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01081249
Sponsor's protocol ID: UCSD IRB 080953
Acronym: OT-PT
Status last verified: Oct 2014
First submitted: 3 Mar 2010
Last updated: 16 Oct 2014
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

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.
PubMed 20047458
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.
PubMed 23810433

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 16 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Physiologic Correlates of Perceived [Therapist] Empathy and Social-Emotional Process During Psychotherapy: Testing Oxytocin in a Cross-Over Design Pilot Study
ClinicalTrials.gov ID: NCT01081249
Acronym / sponsor ID: OT-PT / UCSD IRB 080953
Conditions: Behavior, Anxiety
Keywords: psychotherapy
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 18 participants (actual)
Lead sponsor: MacDonald, Kai, M.D.
Study start: Dec 2008
Primary completion: Jul 2012 (actual)
Study completion: Jul 2012 (actual)
First posted: 5 Mar 2010 (estimated)
Results: Posted 16 Oct 2014

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Triple blind (participant, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Placebo then Oxytocin	Experimental	Drug: Placebo then intranasal oxytocinParticipant was randomized to receive placebo before the first psychotherapy session, and then received the active drug at the second visit.
Oxytocin then placebo	Experimental	Drug: Intranasal oxytocin then placeboParticipant was randomized to receive placebo before the first psychotherapy session, and then received the active drug at the second visit.

Who may qualify

Ages: 18 to 65 years
Sex: Male only
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (2 listed)

in current mental health treatment
male 18-65

Key exclusion criteria (4 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Placebo then intranasal oxytocinParticipant received intranasal placebo spray at first psychotherapy session, and received a single dose of 40 IU intranasal oxytocin at the second session.	Drug	Placebo then Oxytocin
Intranasal oxytocin then placeboParticipant 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.	Drug	Oxytocin then placebo

Primary outcome

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
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.

3 secondary outcomes

Salivary Cortisol
Time frame: before drug, before session, and 20 minutes after session
Heart Rate Variability (HRV)
Time frame: continuously monitored from time before drug delivery to 20 minutes after session
Subjective Ratings of Anxiety and Trust of the Therapist
Time frame: measured before drug, immediately before session, and after the session

Results and safety

Results posted to the registry on 16 Oct 2014, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Oxytocin Then Placebo	11	11
Placebo Then Oxytocin	7	6

Primary outcome: 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. Mean (Standard Deviation). Unit: Number of behaviors exhibited

Measure	Placebo n = 17	Active Drug n = 17
ECSI eye contact	34 (2.2)	34.8 (2.4)
ECSI affiliation	45.4 (5.1)	46.0 (4.5)
ECSI submission	24.4 (6.1)	25.14 (5.6)
ECSI prosocial	69.8 (7.3)	71.1 (7.3)
ECSI flight	65.7 (2.9)	61.1 (4.0)
ECSI assertion	30.5 (5.7)	26.6 (3.9)
ECSI displacement	46.6 (3.9)	41.6 (5.2)
ECSI relaxation	19.4 (4.4)	18.7 (3.3)

3 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Placebo Then Oxytocin	0 of 6 (0%)	0 of 6 (0%)	Not reported
Oxytocin Then Placebo	0 of 11 (0%)	0 of 11 (0%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2014.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 20047458Macdonald 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.
Derived from this study: PubMed 23810433MacDonald 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.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Kai MacDonald, MD principal investigator

UCSD

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study of Behavior and Anxiety, run by MacDonald, Kai, M.D. at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 16 Oct 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 16 Oct 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01081249, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Oct 2014.