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

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.

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Key information

Conditions

PTSD Mental Disorders Stress Disorders, Post-Traumatic Stress Disorders, Traumatic Trauma and Stressor Related Disorders

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Clinical Neurosciences Division-Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Oxytocin

Drug

Other names: Pitocin

Placebo

Drug

Other names: Saline

Primary outcomes

Change in Amygdala Activation- Oxy Minus Placebo

Time frame: Days 1 and 2

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.

Sponsors and collaborators

Lead sponsor

Megan Moran-Santa Maria

Other

Registry information

Important dates

Study start: 2013
Primary completion: 2015
Study completion: 2015
First posted: Oct 16, 2013
Registry last updated: Dec 11, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed