Effects of Oxytocin on Behavior and Physiology in a Psychotherapy Setting

NCT ID: NCT01081249

Last Updated: 2014-10-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 18 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-12-31
• Study Completion Date: 2012-07-31

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.

Conditions

Behavior; Anxiety

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Placebo then Oxytocin

Participant was randomized to receive placebo before the first psychotherapy session, and then received the active drug at the second visit.

Group Type: EXPERIMENTAL

Placebo then intranasal oxytocin

Intervention Type: DRUG

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

Oxytocin then placebo

Participant was randomized to receive placebo before the first psychotherapy session, and then received the active drug at the second visit.

Group Type: EXPERIMENTAL

Intranasal oxytocin then placebo

Intervention Type: DRUG

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.

Interventions

Placebo then intranasal oxytocin

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

Intervention Type: DRUG

Intranasal oxytocin then placebo

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.

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

MacDonald, Kai, M.D.

INDIV

Sponsor Role: lead

Responsible Party

Kai MacDonald

Assistant clinical professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Kai MacDonald, MD

Role: PRINCIPAL_INVESTIGATOR

UCSD

Locations

Kai MacDonald, MD 3368 2nd Ave Ste B

San Diego, California, United States

Countries

United States

References

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.

Reference Type: BACKGROUND

PMID: 20047458 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 23810433 (View on PubMed)

Other Identifiers

UCSD IRB 080953

Identifier Type: -

Identifier Source: org_study_id