Sex/Gender Differences in Risk and Resilience to PTSD; Implication of Oxytocin
NCT ID: NCT01963078
Last Updated: 2018-12-11
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
38 participants
INTERVENTIONAL
2013-04-30
2015-01-31
Brief Summary
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Hypothesis 1: Amygdala responding will be greater in subjects with PTSD as compared to resilient subjects, and no sex differences in the magnitude of the response will be found.
Hypothesis 2A: In response to OT, women will exhibit a greater reduction in amygdala responding than men.
Hypothesis 2B: In response to OT, women with PTSD will exhibit a greater reduction in amygdala responding compared to women without PTSD.
Hypothesis 3A: Women with PTSD will have lower levels of plasma OT as compared to men with PTSD, and women and men without PTSD.
Hypothesis 3B: Plasma OT levels will be inversely correlated with amygdala responding to fearful faces in women but not in men.
Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
OTHER
DOUBLE
Study Groups
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PTSD placebo Day 1, Oxytocin Day 2
Participants PTSD will self-administer matching placebo (containing all ingredients except OT) at 10:30 a.m. on Day 1 of study procedures, approximately 45-minutes prior the scanning sessions. This dose and timing of administration were selected based on similar fMRI studies (Domes, et al., 2007; Domes, et al., 2010; Kirsch, et al., 2005).
Placebo
PTSD Oxytocin Day 1, Placebo Day 2
Participants with PTSD will self-administer 24 IUs of OT nasal spray at 10:30 a.m. on Day 1 of study procedures, approximately 45-minutes prior the scanning sessions. This dose and timing of administration were selected based on similar fMRI studies (Domes, et al., 2007; Domes, et al., 2010; Kirsch, et al., 2005).
Oxytocin
Resilient Placebo Day 1, Oxytocin Day 2
Resilient controls will self-administer matching placebo spray at 10:30 a.m. on Day 1 of study procedures, approximately 45-minutes prior the scanning sessions. This dose and timing of administration were selected based on similar fMRI studies (Domes, et al., 2007; Domes, et al., 2010; Kirsch, et al., 2005).
Placebo
Resilient Oxytocin Day 1, Placebo Day 2
Resilient controls will self-administer 24 IUs of OT nasal spray at 10:30 a.m.on Day 1 of study procedures, approximately 45-minutes prior the scanning sessions. This dose and timing of administration were selected based on similar fMRI studies (Domes, et al., 2007; Domes, et al., 2010; Kirsch, et al., 2005).
Oxytocin
Interventions
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Oxytocin
Placebo
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Subjects scoring moderate to severe (\>3) on a minimum of one of the five trauma domains of the Childhood Trauma Questionnaire.
3. Subjects must have experienced, witnessed, or confronted an event(s) that involved actual or threatened death or serious injury, or a threat to the physical integrity of themselves, or others and the person's response involved intense fear, helplessness, and/or horror (Criterion A DSM-IV for PTSD), prior to the age of 18.
Exclusion Criteria
2. Subjects with current (past 90 days) psychotic disorder or bipolar affective disorder.
3. Subjects with any psychoactive substance abuse within the last 30 days as evidenced by subject report or urine drug screen.
4. Women who are pregnant or nursing.
5. Women who are post-menopausal or have had a full hysterectomy.
6. Subjects who have a BMI greater than 35.
7. Subjects who are unwilling to maintain abstinence from alcohol and caffeine for the 24-hour period prior to the study visits and from illicit drug use for the 72 hour period prior to study visits.
8. Persons with ferrous metal implants or pacemaker.
9. Subjects who are claustrophobic.
10. Subjects taking endocrine or cardiovascular medications (other than blood pressure medications) during the 30-day period prior to the study.
1. As above.
1\. Subjects meeting criteria for current or past (i.e. last 90 days) Axis I mood or anxiety disorders (including PTSD and depression).
18 Years
50 Years
ALL
No
Sponsors
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Megan Moran-Santa Maria
OTHER
Responsible Party
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Megan Moran-Santa Maria
Assistant Professor
Principal Investigators
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Megan Moran- Santa Maria, PhD
Role: PRINCIPAL_INVESTIGATOR
Medical University of South Carolina
Locations
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Clinical Neurosciences Division-Medical University of South Carolina
Charleston, South Carolina, United States
Countries
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References
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Sippel LM, Flanagan JC, Holtzheimer PE, Moran-Santa-Maria MM, Brady KT, Joseph JE. Effects of intranasal oxytocin on threat- and reward-related functional connectivity in men and women with and without childhood abuse-related PTSD. Psychiatry Res Neuroimaging. 2021 Nov 30;317:111368. doi: 10.1016/j.pscychresns.2021.111368. Epub 2021 Aug 20.
Other Identifiers
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