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Oxytocin and Affect Processing in Posttraumatic Stress Disorder

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ClinicalTrials.gov Identifier: NCT02546570
Recruitment Status : Unknown
Verified December 2016 by Yale University.
Recruitment status was:  Active, not recruiting
First Posted : September 11, 2015
Last Update Posted : December 16, 2016
Sponsor:
Information provided by (Responsible Party):
Yale University

Brief Summary:
The investigators will use multiple methods (including Oxytocin intranasal inhalation, neuroimaging, behavioral measures, peripheral hormone measurements) to examine how individuals' behavior, cognition, and brain function is impacted by the neuro-hormone Oxytocin. Specifically, the investigators plan to evaluate the influence of Oxytocin administration on affective processing in non-trauma exposed and trauma-exposed adults (both with and without posttraumatic stress disorder, PTSD).

Condition or disease Intervention/treatment Phase
Posttraumatic Stress Disorder (PTSD) Drug: Oxytocin Drug: Placebo Phase 4

Detailed Description:
The investigators will use multiple methods (including Oxytocin intranasal inhalation, neuroimaging, behavioral measures, peripheral hormone measurements) to examine how individuals' behavior, cognition, and brain function is impacted by the neuro-hormone Oxytocin. Specifically, the investigators plan to evaluate the influence of Oxytocin administration on affective processing in non-trauma exposed and trauma-exposed adults (both with and without posttraumatic stress disorder, PTSD). The investigators expect oxytocin (compared to placebo) to positively influence affect processing in healthy subjects, as well as among those diagnosed with PTSD. Given current literature, the investigators expect oxytocin to elevate the processing\perception of positive-related stimuli, and reduce the salience of aversive or un-pleasant cues. The investigators expect oxytocin to impact participants' brain function as measured with functional magnetic resonance imaging (fMRI) while visually processing social and affect-related stimuli, rendering brain function and affective processing to be "more typical" or "adaptive" compared to placebo. Oxytocin's effect on human repertoire is not necessarily direct, but can interact with the individual's socioemotional characteristics, early life environment, and psychiatric symptoms. Therefore, the investigators will incorporate measures that capture the various dimensions that likely shape the effect of oxytocin.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 11 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Posttraumatic Stress Disorder and Affective Functioning: A Test of the Potentially Normalizing Effects of Oxytocin
Study Start Date : August 2015
Estimated Primary Completion Date : September 2017
Estimated Study Completion Date : September 2017

Resource links provided by the National Library of Medicine

Drug Information available for: Oxytocin

Arm Intervention/treatment
Experimental: Healthy adult controls (18-55)
Drug: oxytocin and placebo nasal spray (within-subjects design, blinded and counterbalanced for two lab sessions); dosage=24 international units (IU). Participant inserts nasal spray container 1cm into nostril at angle of 45 degrees and sprays. Will wait 15 seconds then repeat administration to other nostril (alternating between nostrils). Participants will receive 6 puffs in total (3 in each nostril).
Drug: Oxytocin
See arm/group descriptions for dosage amount and procedure.
Other Name: Pitocin

Drug: Placebo
See arm/group descriptions for dosage amount and procedure.
Other Name: saline

Experimental: Adults with PTSD (18-55)
Drug: oxytocin and placebo nasal spray (within-subjects design, blinded and counterbalanced for two lab sessions); dosage=24 international units (IU). Participant inserts nasal spray container 1cm into nostril at angle of 45 degrees and sprays. Will wait 15 seconds then repeat administration to other nostril (alternating between nostrils). Participants will receive 6 puffs in total (3 in each nostril).
Drug: Oxytocin
See arm/group descriptions for dosage amount and procedure.
Other Name: Pitocin

Drug: Placebo
See arm/group descriptions for dosage amount and procedure.
Other Name: saline

Experimental: Trauma-exposed/no-PTSD adults (18-55)
Drug: oxytocin and placebo nasal spray (within-subjects design, blinded and counterbalanced for two lab sessions); dosage=24 international units (IU). Participant inserts nasal spray container 1cm into nostril at angle of 45 degrees and sprays. Will wait 15 seconds then repeat administration to other nostril (alternating between nostrils). Participants will receive 6 puffs in total (3 in each nostril).
Drug: Oxytocin
See arm/group descriptions for dosage amount and procedure.
Other Name: Pitocin

Drug: Placebo
See arm/group descriptions for dosage amount and procedure.
Other Name: saline




Primary Outcome Measures :
  1. fMRI analysis [ Time Frame: 1 week; fMRI data collected at second and third visits, one week apart ]
    Change in blood-oxygen-level dependent (BOLD) contrast signal in regions of interest relevant to fear/threat (e.g., decrease in amygdala activation) and reward processing (increase in ventral striatum activation) in oxytocin versus placebo sessions. Expect this change across tasks with different types of stimuli (auditory, tactile). The fMRI data will be analyzed using signal processing and multivariate statistical techniques within a combination of commercially available (Brain Voyager QX, Analyze) and in-house software. Group differences will be evaluated using standard regression and general linear model approaches. Research hypotheses concerning the effect of exogenous oxytocin on neuro-affective processing will be tested using repeated-measures ANOVA or ANCOVA, linear regression models, and correlational analysis.


Secondary Outcome Measures :
  1. Salivary oxytocin [ Time Frame: Within session (30 min) and between sessions (1 week); saliva samples collected twice (before and after OT administration) at both second and third visits, one week apart ]
    Expect within-session (30 min) increase in peripheral salivary oxytocin level during OT sessions (within-session), and higher OT levels in oxytocin administration vs. placebo sessions. Peripheral OT levels measured with Salivettes (sterile cotton participants will be asked to chew on for 1 minutes).



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Adults: age 18-55
  • Be in good medical health
  • Be cooperative with testing
  • English is a language spoken in the family
  • PTSD as diagnosed by a certified clinician or the research team for PTSD group.

Exclusion Criteria:

  • Moderate or severe acute or chronic medical illnesses (e.g.cardiac disease, diabetes, epilepsy, influenza).
  • History of hypertension with baseline blood pressure above 160 mm Hg (systolic) over 100 mm Hg (diastolic).
  • history of syncope and/or baseline blood pressure below 100 mm Hg (systolic).
  • weight >300lb
  • The use of some psychotropic medications will not be allowed. Females taking contraceptive hormones will not be able to participate in the study.
  • Currently breast feeding or pregnant
  • For MRI ONLY: Any metal or electromagnetic implants
  • For MRI ONLY: Significant hearing loss or other severe sensory impairment
  • A fragile health status.
  • For MRI ONLY: A history of seizures or current use of anticonvulsants
  • Healthy adult controls (HC):
  • Be free of both neurological and psychiatric disorders (current and past) on the basis of self-report
  • Be free of psychiatric disorders

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02546570


Locations
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United States, Connecticut
Yale University
New Haven, Connecticut, United States, 06520
Sponsors and Collaborators
Yale University
Investigators
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Principal Investigator: Linda Mayes, MD Yale University

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Responsible Party: Yale University
ClinicalTrials.gov Identifier: NCT02546570     History of Changes
Other Study ID Numbers: 1502015347
First Posted: September 11, 2015    Key Record Dates
Last Update Posted: December 16, 2016
Last Verified: December 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Additional relevant MeSH terms:
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Disease
Stress Disorders, Traumatic
Stress Disorders, Post-Traumatic
Pathologic Processes
Trauma and Stressor Related Disorders
Mental Disorders
Oxytocin
Oxytocics
Reproductive Control Agents
Physiological Effects of Drugs