Phase 2
N=11
Oxytocin and Affect Processing in Posttraumatic Stress Disorder
Posttraumatic Stress Disorder (PTSD)
Bottom Line
View on ClinicalTrials.gov: NCT02546570 ↗Enrolled (actual)
11
Serious AEs
0.0%
Results posted
Apr 2020
Primary outcome: Primary: fMRI Analysis: Change in Anterior Insula Region — -12.6; -1.6; 10.6; -7.8 percentage of area activation
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Oxytocin (Drug); Placebo (Drug)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- Yale University
- Primary completion
- Aug 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY fMRI Analysis: Change in Anterior Insula Region |
-12.6; -1.6; 10.6; -7.8; -13.9; 3.9 | — |
| PRIMARY fMRI Analysis: Change in Accumbens Region |
7.6; -7.9; -17.2; -12.7; -14.8; -8.0 | — |
| PRIMARY fMRI Analysis: Change in Amygdala Region |
-3.8; -9.1; 14.5; -6.7; -4.2; .58 | — |
| PRIMARY fMRI Analysis: Change in dACC Region |
-20.9; -16.4; -4.8; -30.2; -23.8; -7.5 | — |
| PRIMARY fMRI Analysis: Change in mOFC Region |
1.5; 2.5; 1.7; -8.1; -4.9; 12.3 | — |
| PRIMARY fMRI Analysis: Change in rACC Region |
-5.9; -4.4; -0.2; -16.3; -9.2; 0.7 | — |
| PRIMARY fMRI Analysis: Change in vmPFC Region |
-3.8; -6.8; -3.3; -16.0; -12.0; 2.4 | — |
| SECONDARY Salivary Oxytocin |
— | — |
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).
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
Data sourced from ClinicalTrials.gov (NCT02546570). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.