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Trial · Interventional

CompletedEarly phase 1Registry data

Study of the Effects of Oxytocin on Attentional Bias and Startle in PTSD

NCTNCT03211013 (opens ClinicalTrials.gov in a new tab)Other idWOS0022ADM
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Completed
Phase
Early phase 1
Enrollment
17 participants (actual)
Sponsor
Palo Alto Veterans Institute for Research · Other
Design
Randomized · Triple masking
Countries
1 country

United States

Start
10 Jul 2017
Primary completion
9 Jun 2021
Completion
9 Jun 2021
First posted
7 Jul 2017
Last update posted
10 Jun 2021
Conditions
Posttraumatic Stress Disorder

Timeline

1 trial · 1 completed

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
201720182019202020212022
  1. Ph Early 1

    Study of the Effects of Oxytocin on Attentional Bias and Startle in PTSD

    NCT03211013

    10 Jul 2017 to 9 Jun 2021

Registry summary

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

The investigators will test whether intranasal oxytocin (24 IU vs placebo) will induce effects on attention bias and startle comparable to those the investigators have shown to be induced by the presence (vs absence) of a service dog in Veterans diagnosed with PTSD. This possibility is suggested by a 2015 study showing that urinary oxytocin levels are elevated in association with mutual gaze between dogs and their owners.

Interventions

  • OxytocinDrug
  • PlacebosDrug

Arms2

  • Experimental

    Immediate Oxytocin

    Participants randomly assigned to this arm will receive OT nasal spray (24 IU) at laboratory visit 1 and placebo nasal spray at visit 2. The order will be masked for participants and study staff.

  • Placebo comparator

    Delayed Oxytocin

    Participants randomly assigned to this arm will receive placebo nasal spray at laboratory visit 1 and OT nasal spray (24 IU) at visit 2. The order will be masked for participants and study staff.

Primary outcomes2

Outcomes the sponsor listed as primary.

  1. Change in attentional bias

    Time frame · 1-2 weeks

    Registry description

    Changes between oxytocin vs. placebo lab sessions in the asymmetric allocation of visual attention to one or another of a pair of visual stimuli presented simultaneously as quantified by gaze tracking

  2. Change in startle response -heart rate

    Time frame · 1-2 weeks

    Registry description

    Difference between oxytocin vs. placebo lab sessions in the magnitude of pre-to-post startle stimulus change in heart rate

Posted results

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

No results are posted for this trial.

Completed trials do not always post results.

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

Studies18

Studies that cite this trial.

Studies with results

12 studies on this page

Indexing hint: Randomized controlled trial · 2017

2 results

Intranasal oxytocin increases neural responses to social reward in post-traumatic stress disorder.

Nawijn et al. 2017Social cognitive and affective neurosciencecited by 59

PMID 27614769PMC5390752DOI 10.1093/scan/nsw123PUB-27614769

Free to read · publisher termsCC BY-NC2 results
Read at sourceSee results (2)

Indexing hint: Randomized controlled trial · 2016

2 results

Effects of intranasal oxytocin on amygdala reactivity to emotional faces in recently trauma-exposed individuals.

Frijling et al. 2016Social cognitive and affective neurosciencecited by 55

PMID 26382634PMC4733344DOI 10.1093/scan/nsv116PUB-26382634

Free to read · publisher termsCC BY-NC2 results
Read at sourceSee results (2)

Indexing hint: Randomized controlled trial · 2016

2 results

Oxytocin improves compassion toward women among patients with PTSD.

Palgi et al. 2016Psychoneuroendocrinologycited by 28

PMID 26671007DOI 10.1016/j.psyneuen.2015.11.008PUB-26671007

Full text at the publisher2 results
Publisher pageSee results (2)

Indexing hint: Randomized controlled trial · 2016

3 results

Intranasal Oxytocin Normalizes Amygdala Functional Connectivity in Posttraumatic Stress Disorder.

Koch et al. 2016Neuropsychopharmacology : official publication of the American College of Neuropsychopharmacologycited by 116

PMID 26741286PMC4908648DOI 10.1038/npp.2016.1PUB-26741286

Rights unknown3 results
Source linkSee results (3)

Indexing hint: Observational study · 2011

4 results

Oxytocin reduces background anxiety in a fear-potentiated startle paradigm: peripheral vs central administration.

Ayers et al. 2011Neuropsychopharmacology : official publication of the American College of Neuropsychopharmacologycited by 75

PMID 21796104PMC3194076DOI 10.1038/npp.2011.138PUB-21796104

Rights unknown4 results
Source linkSee results (4)

Indexing hint: Clinical trial · 2009

2 results

Intranasal oxytocin increases positive communication and reduces cortisol levels during couple conflict.

Ditzen et al. 2009Biological psychiatrycited by 478

PMID 19027101DOI 10.1016/j.biopsych.2008.10.011PUB-19027101

Full text at the publisher2 results
Publisher pageSee results (2)

Indexing hint: Randomized controlled trial · 2009

4 results

Oxytocin makes a face in memory familiar.

Rimmele et al. 2009The Journal of neuroscience : the official journal of the Society for Neurosciencecited by 288

PMID 19129382PMC6664913DOI 10.1523/jneurosci.4260-08.2009PUB-19129382

Free to read · publisher termsCC BY-NC4 results
Read at sourceSee results (4)

Indexing hint: Randomized controlled trial · 2008

2 results

Oxytocin increases gaze to the eye region of human faces.

Guastella et al. 2008Biological psychiatrycited by 538

PMID 17888410DOI 10.1016/j.biopsych.2007.06.026PUB-17888410

Full text at the publisher2 results
Publisher pageSee results (2)

Indexing hint: Randomized controlled trial · 2008

4 results

Oxytocin shapes the neural circuitry of trust and trust adaptation in humans.

Baumgartner et al. 2008Neuroncited by 700

PMID 18498743DOI 10.1016/j.neuron.2008.04.009PUB-18498743

Rights unknown4 results
Source linkSee results (4)

Indexing hint: Randomized controlled trial · 2007

2 results

Oxytocin improves "mind-reading" in humans.

Domes et al. 2007Biological psychiatrycited by 826

PMID 17137561DOI 10.1016/j.biopsych.2006.07.015PUB-17137561

Full text at the publisher2 results
Publisher pageSee results (2)

Indexing hint: Clinical trial · 2005

3 results

Oxytocin increases trust in humans.

Kosfeld et al. 2005Naturecited by 1,701

PMID 15931222DOI 10.1038/nature03701PUB-15931222

Full text at the publisher3 results
Publisher pageSee results (3)

Indexing hint: Observational study · 2005

2 results

Oxytocin modulates neural circuitry for social cognition and fear in humans.

Kirsch et al. 2005The Journal of neuroscience : the official journal of the Society for Neurosciencecited by 1,030

PMID 16339042PMC6725903DOI 10.1523/jneurosci.3984-05.2005PUB-16339042

Free to read · publisher termsCC BY-NC2 results
Read at sourceSee results (2)

More studies

6 studies on this page

PubMed tag: none · 2015

Social evolution. Oxytocin-gaze positive loop and the coevolution of human-dog bonds.

Nagasawa et al. 2015Science (New York, N.Y.)cited by 380

PMID 25883356DOI 10.1126/science.1261022PUB-25883356

Full text at the publisher
Publisher page

PubMed tag: none · 2014

Intranasal oxytocin attenuates the human acoustic startle response independent of emotional modulation.

Ellenbogen et al. 2014Psychophysiologycited by 20

PMID 25082371DOI 10.1111/psyp.12263PUB-25082371

Full text at the publisher
Publisher page

Indexing hint: Animal study · 2010

Oxytocin and same-sex social behavior in female meadow voles.

Beery et al. 2010Neurosciencecited by 87

PMID 20580660DOI 10.1016/j.neuroscience.2010.05.023PUB-20580660

Full text at the publisher
Publisher page

Indexing hint: Animal study · 2010

Normal maternal behavior, but increased pup mortality, in conditional oxytocin receptor knockout females.

Macbeth et al. 2010Behavioral neurosciencecited by 68

PMID 20939667PMC3175421DOI 10.1037/a0020799PUB-20939667

Rights unknown
Source link

PubMed tag: none · 2009

Oxytocin and social perception: oxytocin increases perceived facial trustworthiness and attractiveness.

Theodoridou et al. 2009Hormones and behaviorcited by 213

PMID 19344725DOI 10.1016/j.yhbeh.2009.03.019PUB-19344725

Full text at the publisher
Publisher page

PubMed tag: none · 2007

Oxytocin increases generosity in humans.

Zak et al. 2007PloS onecited by 351

PMID 17987115PMC2040517DOI 10.1371/journal.pone.0001128PUB-17987115

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Eligibility

Who could join, as posted.

Sex
Male
Age
from 18 Years up to 65 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria: * US military Veteran * Current posttraumatic stress disorder * Medically healthy Exclusion Criteria: * DSM-5 diagnosis of schizophrenia, schizoaffective disorder, or psychotic disorder * Active drug or alcohol use disorder within past 90 days * Currently participating in a clinical drug trial * Regular nasal obstruction or nosebleeds (use of saline or nasal decongestant permitted if subject has transient cold only) * Active medical problems: unstable seizures, significant physical illness (e.g., serious liver, renal, or cardiac pathology) * Sensitivity to preservatives, in particular E 216, E 218, and chlorobutanol hemihydrate * Significant hearing or vision impairments * Habitually drinks large volumes of water

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