Trial · Interventional

CompletedPhase 2Results postedRegistry data

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

NCTNCT01963078Other id1R21MH099619-01

Open at ClinicalTrials.govAsk about this trial

Overview

Status: Completed
Phase: Phase 2
Enrollment: 38 participants (actual)
Sponsor: Megan Moran-Santa Maria · Other
Design: Randomized · Double masking
Countries: 1 country
United States
Start: Apr 2013
Primary completion: Jan 2015
Completion: Jan 2015
First posted: 16 Oct 2013 (estimated)
Last update posted: 11 Dec 2018
Conditions: PTSD

Timeline

1 trial · 1 completed · 1 with posted results

Completed
Ongoing
Not yet recruiting
Stopped
Estimated dates (est.)
Results posted

2013201420152016

Ph 2
Sex/Gender Differences in Risk and Resilience to PTSD; Implication of Oxytocin
NCT01963078
Apr 2013 to Jan 2015

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

OxytocinDrug
PlaceboDrug

Arms4

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).
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).
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).
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).

Primary outcomes1

Outcomes the sponsor listed as primary.

Change in Amygdala Activation- Oxy Minus Placebo
Time frame · Days 1 and 2
Registry description
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.

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeMean· Days 1 and 2

Change in Amygdala Activation- Oxy Minus Placebo

Group	Value (percentage of BOLD signal change)	Spread
PTSD Placebo Day 1, Oxytocin Day 2	-0.01	0.36
PTSD Oxytocin Day 1, Placebo Day 2	-0.02	0.41
Resilient Placebo Day 1, Oxytocin Day 2	0.05	0.54
Resilient Oxytocin Day 1, Placebo Day 2	0.21	0.33

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
Group	Deaths	Serious events	Other events
PTSD PlaceboParticipants 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	0 / 19	0 / 19	0 / 19
PTSD OxytocinParticipants 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	0 / 19	0 / 19	0 / 19
Resilient PlaceboResilient 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	0 / 19	0 / 19	0 / 19
Resilient OxytocinResilient 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	0 / 19	0 / 19	0 / 19

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies1

Studies that cite this trial.

Studies with results

1 study on this page

Indexing hint: Randomized controlled trial · 2021

9 results

Effects of intranasal oxytocin on threat- and reward-related functional connectivity in men and women with and without childhood abuse-related PTSD.

Sippel et al. 2021Psychiatry research. Neuroimagingcited by 16

PMID 34455213PMC8572525DOI 10.1016/j.pscychresns.2021.111368PUB-34455213

Rights unknown9 results

Source link See results (9)

Eligibility

Who could join, as posted.

Sex: All
Age: from 18 Years up to 50 Years
Healthy volunteers: Not accepted

Inclusion and exclusion criteria, as posted

Inclusion Criteria 1. Ages 18-60. 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 1. Subjects with evidence of or a history of head trauma, neurological disorders, seizures, unconsciousness or any other major medical disorder. 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. 11. Subjects with a postive breathalyzer or urine drug screen. Group - Specific Inclusion/Exclusion Criteria Individuals with PTSD Inclusion Criteria 1\. 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 1. As above. 2. Substance dependence within the past year, except for nicotine or alcohol. Resilient Controls Inclusion Criteria 1\. As above. Exclusion Criteria 1\. Subjects meeting criteria for current or past (i.e. last 90 days) Axis I mood or anxiety disorders (including PTSD and depression).

PepBank is a research reference. Talk to a doctor before you use any peptide.