Clinical trial NCT02546570: Oxytocin and Affect Processing in Posttraumatic Stress Disorder
Official title: Posttraumatic Stress Disorder and Affective Functioning: A Test of the Potentially Normalizing Effects of Oxytocin
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Posttraumatic Stress Disorder (PTSD)
Lead sponsor: Yale University
Sponsor class: OTHER
Collaborators: name: National Center for PTSD
First posted: 2015-09-11
Enrollment: 11
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

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.

Eligibility 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

Primary outcomes:
measure: fMRI Analysis: Change in Anterior Insula Region
timeFrame: 1 week; fMRI data collected at second and third visits, one week apart
measure: fMRI Analysis: Change in Accumbens Region
timeFrame: 1 week; fMRI data collected at second and third visits, one week apart
measure: fMRI Analysis: Change in Amygdala Region
timeFrame: 1 week; fMRI data collected at second and third visits, one week apart
measure: fMRI Analysis: Change in dACC Region
timeFrame: 1 week; fMRI data collected at second and third visits, one week apart
measure: fMRI Analysis: Change in mOFC Region
timeFrame: 1 week; fMRI data collected at second and third visits, one week apart
measure: fMRI Analysis: Change in rACC Region
timeFrame: 1 week; fMRI data collected at second and third visits, one week apart
measure: fMRI Analysis: Change in vmPFC Region
timeFrame: 1 week; fMRI data collected at second and third visits, one week apart
Secondary outcomes:
measure: Salivary Oxytocin
timeFrame: 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
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Yale University
state: Connecticut
Study officials:
affiliation: Yale University
name: Linda Mayes, MD
role: PRINCIPAL_INVESTIGATOR
References: