CompletedNCT01963078Updated Dec 11, 2018Results posted

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

A Phase 2 interventional study of Oxytocin and Placebo in PTSD, sponsored by Megan Moran-Santa Maria. Completed at 1 site in United States. Open to participants aged 18 Years to 50 Years. Per ClinicalTrials.gov, last updated 2018-12-11.

Sponsored by Megan Moran-Santa Maria · Phase 2, Interventional, and Other

Phase: Phase 2
Study type: Interventional
Enrollment: 38
Allocation: Randomized
Ages: 18 Years to 50 Years
Sex: All

Study 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.

Conditions studied

PTSD

In context

Lead sponsor

This is the only study on the registry with Megan Moran-Santa Maria as lead sponsor.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years to 50 Years
Sexes eligible: All
Accepts healthy volunteers: No

Eligibility criteria

Inclusion Criteria

Ages 18-60.
Subjects scoring moderate to severe (>3) on a minimum of one of the five trauma domains of the Childhood Trauma Questionnaire.
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

Subjects with evidence of or a history of head trauma, neurological disorders, seizures, unconsciousness or any other major medical disorder.
Subjects with current (past 90 days) psychotic disorder or bipolar affective disorder.
Subjects with any psychoactive substance abuse within the last 30 days as evidenced by subject report or urine drug screen.
Women who are pregnant or nursing.
Women who are post-menopausal or have had a full hysterectomy.
Subjects who have a BMI greater than 35.
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.
Persons with ferrous metal implants or pacemaker.
Subjects who are claustrophobic.
Subjects taking endocrine or cardiovascular medications (other than blood pressure medications) during the 30-day period prior to the study.
Subjects with a postive breathalyzer or urine drug screen. Group - Specific Inclusion/Exclusion Criteria Individuals with PTSD Inclusion Criteria

Subjects must meet DSM-IV criteria for current (i.e. last 6 months) PTSD. 2. Subjects may also meet criteria for a mood disorder (except bipolar affective disorder, see Exclusion Criteria) or other anxiety disorders (panic disorder, agoraphobia, social phobia, generalized anxiety disorder, or obsessive compulsive disorder) or past (>90 days) alcohol dependence. The inclusion of subjects with affective and other anxiety disorders is essential because of the marked frequency of the co-existence of mood and other anxiety disorders among patients with PTSD (Brady, Killeen, Brewerton, \& Lucerini, 2000; Kessler, Chiu, Demler, Merikangas, \& Walters, 2005).

Exclusion Criteria

As above.
Substance dependence within the past year, except for nicotine or alcohol. Resilient Controls Inclusion Criteria

As above. Exclusion Criteria

Subjects meeting criteria for current or past (i.e. last 90 days) Axis I mood or anxiety disorders (including PTSD and depression).

Study design

Phase: Phase 2
Primary purpose: Other
Allocation: Randomized
Intervention model: Crossover assignment
Masking: Double (Participant, Investigator)
Enrollment: 38 participants (actual)

Study arms

Placebo comparator
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).
Drug: Placebo
Experimental
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).
Drug: Oxytocin
Placebo comparator
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).
Drug: Placebo
Experimental
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).
Drug: Oxytocin

Interventions

DrugOxytocin
Also known as: Pitocin
DrugPlacebo
Also known as: Saline

What researchers measure

Primary outcomes

Change in Amygdala Activation- Oxy Minus Placebo
Bold signal response to facial recognition task was contrasted between oxytocin and saline administrations. Participants with PTSD and Resilient Controls each underwent 2 sets of scanning procedures, one with placebo and one with Oxytocin. Participants were randomly assigned to received Oxytocin on Day 1 or Day 2, and placebo on the opposite day, to mitigate crossover effects. Outcome measure is change in bold signal response between the two days; bold signal response on placebo was subtracted from bold signal response on Oxytocin to obtain change score.
Time frame: Days 1 and 2

Results

Posted Dec 11, 2018

Participant flow

Participants were recruited primarily through media advertisements and flyers.

Participant flow — Overall Study
Milestone	PTSD Placebo Day 1, Oxytocin Day 2	PTSD Oxytocin Day 1, Placebo Day 2	Resilient Placebo Day 1, Oxytocin Day 2	Resilient Oxytocin Day 1, Placebo Day 2
Started	9	10	10	9
Completed	8	9	9	7
Not completed	1	1	1	2

Outcome measures

PrimaryChange in Amygdala Activation- Oxy Minus Placebo

Bold signal response to facial recognition task was contrasted between oxytocin and saline administrations. Participants with PTSD and Resilient Controls each underwent 2 sets of scanning procedures, one with placebo and one with Oxytocin. Participants were randomly assigned to received Oxytocin on Day 1 or Day 2, and placebo on the opposite day, to mitigate crossover effects. Outcome measure is change in bold signal response between the two days; bold signal response on placebo was subtracted from bold signal response on Oxytocin to obtain change score.

Time frame:: Days 1 and 2
Reported as:: Mean · percentage of BOLD signal change

Change in Amygdala Activation- Oxy Minus Placebo
percentage of BOLD signal change	PTSD Placebo Day 1, Oxytocin Day 2	PTSD Oxytocin Day 1, Placebo Day 2	Resilient Placebo Day 1, Oxytocin Day 2	Resilient Oxytocin Day 1, Placebo Day 2
Change in Amygdala Activation- Oxy Minus Placebo	-0.01 ± 0.36	-0.02 ± 0.41	0.05 ± 0.54	0.21 ± 0.33

Adverse events

Collected over Adverse events were collected for each participant under both conditions, placebo and Oxytocin. Adverse events are reported summarily for each group.. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
PTSD Placebo	0/19 (0%)	0/19 (0%)	0/19 (0%)
PTSD Oxytocin	0/19 (0%)	0/19 (0%)	0/19 (0%)
Resilient Placebo	0/19 (0%)	0/19 (0%)	0/19 (0%)
Resilient Oxytocin	0/19 (0%)	0/19 (0%)	0/19 (0%)

Baseline characteristics

Age, Categorical
Age, Categorical(Participants)	PTSD Placebo Day 1, Oxytocin Day 2	PTSD Oxytocin Day 1, Placebo Day 2	Resilient Placebo Day 1, Oxytocin Day 2	Resilient Oxytocin Day 1, Placebo Day 2	Total
<=18 years	0	0	0	0	0
Between 18 and 65 years	9	10	10	9	38
>=65 years	0	0	0	0	0

Sex: Female, Male
Sex: Female, Male(Participants)	PTSD Placebo Day 1, Oxytocin Day 2	PTSD Oxytocin Day 1, Placebo Day 2	Resilient Placebo Day 1, Oxytocin Day 2	Resilient Oxytocin Day 1, Placebo Day 2	Total
Female	5	5	5	7	22
Male	4	5	5	2	16

Race (NIH/OMB)
Race (NIH/OMB)(Participants)	PTSD Placebo Day 1, Oxytocin Day 2	PTSD Oxytocin Day 1, Placebo Day 2	Resilient Placebo Day 1, Oxytocin Day 2	Resilient Oxytocin Day 1, Placebo Day 2	Total
American Indian or Alaska Native	0	0	0	0	0
Asian	0	0	0	1	1
Native Hawaiian or Other Pacific Islander	0	0	0	0	0
Black or African American	3	3	2	3	11
White	6	7	8	5	26
More than one race	0	0	0	0	0
Unknown or Not Reported	0	0	0	0	0

Region of Enrollment
Region of Enrollment(Count of Participants)	PTSD Placebo Day 1, Oxytocin Day 2	PTSD Oxytocin Day 1, Placebo Day 2	Resilient Placebo Day 1, Oxytocin Day 2	Resilient Oxytocin Day 1, Placebo Day 2	Total
United States	9	10	10	9	38

Study locations

1 site

Clinical Neurosciences Division-Medical University of South Carolina
Charleston, South Carolina 29425, United States

References and documents

Publications

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. PubMed 34455213 ↗

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Dec 11, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT01963078
Lead sponsor: Megan Moran-Santa Maria
Responsible party: Megan Moran-Santa Maria (Assistant Professor, Medical University of South Carolina) — Sponsor-investigator
First posted: Oct 16, 2013
Start date: Apr 2013
Primary completion: Jan 2015
Completion: Jan 2015
Results posted: Dec 11, 2018
Last update: Dec 11, 2018

Study contacts

Megan Moran- Santa Maria, PhD

principal investigator · Medical University of South Carolina

Oversight

Data monitoring committee: Yes

View the source record on ClinicalTrials.gov ↗

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