CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 38 enrolled
Drug / intervention
Oxytocin +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

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Search/NCT01963078
NCT01963078Phase 2Completed

Sex/Gender Differences in Risk and Resilience to PTSD; Implication of Oxytocin

Megan Moran-Santa Maria·interventional·Posted Oct 16, 2013·Updated Dec 11, 2018

In Brief

A Phase 2 clinical trial evaluating Oxytocin and Placebo for PTSD. Completed, enrolled 38 participants across 1 site.

Detailed Summary

The purpose of the study is to use fMRI to investigate amygdala response to fearful faces in men and women with and without PTSD who have experienced childhood trauma. The study will also compare the effects of oxytocin and placebo on amygdala response, and explore the interaction of oxytocin plasma levels and amygdala response in men and women with and without PTSD who have experienced childhood trauma. 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPTSD
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedOct 16, 2013
Enrollment StartApr 1, 2013
Primary CompletionJan 1, 2015
TodayJul 2, 2026
Enrollment to primary: 1.8 yearsPosted 12.7 years ago

Interventions

Oxytocindrug

Placebodrug