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Trial · Interventional

Status unknownNot applicableRegistry data

The Efficacy of a Single Dose of Intranasal Oxytocin in the Prevention of Post Traumatic Stress Disorder (PTSD)

Overview

Status
Status unknown
Phase
Not applicable
Enrollment
24 participants (estimated)
Sponsor
Sheba Medical Center · Other gov
Design
Randomized · Quadruple masking
Countries
1 country

Israel

Start
Feb 2010
Primary completion
Jan 2011 (estimated)
Completion
Jun 2011 (estimated)
First posted
25 Dec 2009 (estimated)
Last update posted
9 Feb 2010 (estimated)
Conditions
Stress Disorders, Post-Traumatic

Timeline

1 trial

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
201020112012
  1. N/A

    The Efficacy of a Single Dose of Intranasal Oxytocin in the Prevention of Post Traumatic Stress Disorder (PTSD)

    NCT01039766

    Feb 2010 to est. Jun 2011

Registry summary

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

This study is designed to test the hypothesis that a single administration of intranasal oxytocin within 6 hours post-trauma facilitates the physiological recovery for the trauma, thereby preventing the development of Post Traumatic Stress Disorder (PTSD) in the months following the event. In the absence of such treatment (i.e., under placebo conditions), we hypothesize that a greater proportion of persons will develop PTSD (i.e., fail to recover from acute effects).

Interventions

  • OxytocinDrug
  • placebo - saline nasal sprayDrug

Arms2

  • Experimental

    oxytocin

  • Placebo comparator

    Placebo

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. The primary outcome measure is DSM-IV diagnosis of PTSD at the end of the trial.

    Time frame · 13 months

Secondary outcomes(1)
  1. The secondary outcome measure is the severity of PTSD as expressed by the Clinician Administered PTSD Scale (CAPS), at the end of the trial.

    Time frame · 13 months

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.

A trial that is still running, or that stopped early, may post results later.

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

Studies23

Studies that cite this trial.

Studies with results

5 studies on this page

Indexing hint: Meta-analysis (pooled) · 2024

Early pharmacological interventions for prevention of post-traumatic stress disorder (PTSD) in individuals experiencing acute traumatic stress symptoms.

Bertolini et al. 2024The Cochrane database of systematic reviewscited by 4

PMID 38767196PMC11103774DOI 10.1002/14651858.cd013613.pub2PUB-38767196

Rights unknown
Source link

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

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

Indexing hint: Observational study · 2003

3 results

Rearing effects on cerebrospinal fluid oxytocin concentration and social buffering in rhesus monkeys.

Winslow et al. 2003Neuropsychopharmacology : official publication of the American College of Neuropsychopharmacologycited by 224

PMID 12700704DOI 10.1038/sj.npp.1300128PUB-12700704

Full text at the publisher3 results

Indexing hint: Randomized controlled trial · 2003

4 results

Social support and oxytocin interact to suppress cortisol and subjective responses to psychosocial stress.

Heinrichs et al. 2003Biological psychiatrycited by 1,264

PMID 14675803DOI 10.1016/s0006-3223(03)00465-7PUB-14675803

Full text at the publisher4 results

Indexing hint: Observational study · 1986

5 results

Role of oxytocin in the modulation of ACTH release in women.

Suh et al. 1986Neuroendocrinologycited by 20

PMID 3027599DOI 10.1159/000124661PUB-03027599

Full text at the publisher5 results

More studies

17 studies on this page

Indexing hint: Review · 2008

The role of oxytocin in neuropsychiatric disorders.

Marazziti et al. 2008Current medicinal chemistrycited by 63

PMID 18336283DOI 10.2174/092986708783885291PUB-18336283

Full text at the publisher
Publisher page

Indexing hint: Review · 2008

Neuropeptides and social behaviour: effects of oxytocin and vasopressin in humans.

Heinrichs et al. 2008Progress in brain researchcited by 303

PMID 18655894DOI 10.1016/s0079-6123(08)00428-7PUB-18655894

Full text at the publisher
Publisher page

Indexing hint: Review · 2006

The neuroscience of affiliation: forging links between basic and clinical research on neuropeptides and social behavior.

Bartz et al. 2006Hormones and behaviorcited by 206

PMID 16884725DOI 10.1016/j.yhbeh.2006.06.018PUB-16884725

Full text at the publisher
Publisher page

Indexing hint: Review · 2003

Social modulation of stress responses.

DeVries et al. 2003Physiology & behaviorcited by 293

PMID 12954434DOI 10.1016/s0031-9384(03)00152-5PUB-12954434

Full text at the publisher
Publisher page

Indexing hint: Review · 2002

Involvement of the brain oxytocin system in stress coping: interactions with the hypothalamo-pituitary-adrenal axis.

Neumann et al. 2002Progress in brain researchcited by 282

PMID 12436933DOI 10.1016/s0079-6123(02)39014-9PUB-12436933

Full text at the publisher
Publisher page

Indexing hint: Randomized controlled trial · 2001

Effects of suckling on hypothalamic-pituitary-adrenal axis responses to psychosocial stress in postpartum lactating women.

Heinrichs et al. 2001The Journal of clinical endocrinology and metabolismcited by 260

PMID 11600543DOI 10.1210/jcem.86.10.7919PUB-11600543

Rights unknown
Source link

Indexing hint: Animal study · 1998

Attenuated neuroendocrine responses to emotional and physical stressors in pregnant rats involve adenohypophysial changes.

Neumann et al. 1998The Journal of physiologycited by 274

PMID 9490853DOI 10.1111/j.1469-7793.1998.289br.xPUB-09490853

Full text at the publisher
Publisher page

Indexing hint: Review · 1998

Oxytocin may mediate the benefits of positive social interaction and emotions.

Uvnäs-Moberg et al. 1998Psychoneuroendocrinologycited by 518

PMID 9924739DOI 10.1016/s0306-4530(98)00056-0PUB-09924739

Full text at the publisher
Publisher page

Indexing hint: Review · 1998

Effects of early stress on adult affiliative behavior.

Henry et al. 1998Psychoneuroendocrinologycited by 35

PMID 9924741DOI 10.1016/s0306-4530(98)00058-4PUB-09924741

Full text at the publisher
Publisher page

Indexing hint: Review · 1997

Integrative functions of lactational hormones in social behavior and stress management.

Carter et al. 1997Annals of the New York Academy of Sciencescited by 116

PMID 9071349DOI 10.1111/j.1749-6632.1997.tb51918.xPUB-09071349

Full text at the publisher
Publisher page

PubMed tag: none · 1996

Neuroendocrinology of the mother-child interaction.

Uvnäs-Moberg et al. 1996Trends in endocrinology and metabolism: TEMcited by 69

PMID 18406738DOI 10.1016/1043-2760(96)00036-7PUB-18406738

Full text at the publisher
Publisher page

Indexing hint: Animal study · 1994

High doses of oxytocin cause sedation and low doses cause an anxiolytic-like effect in male rats.

Uvnäs-Moberg et al. 1994Pharmacology, biochemistry, and behaviorcited by 191

PMID 7816858DOI 10.1016/0091-3057(94)90462-6PUB-07816858

Full text at the publisher
Publisher page

Indexing hint: Animal study · 1994

Anti-nociceptive effects of oxytocin in rats and mice.

Lundeberg et al. 1994Neuroscience letterscited by 110

PMID 8041495DOI 10.1016/0304-3940(94)90262-3PUB-08041495

Full text at the publisher
Publisher page

Indexing hint: Animal study · 1989

Lactation inhibits stress-mediated secretion of corticosterone and oxytocin and hypothalamic accumulation of corticotropin-releasing factor and enkephalin messenger ribonucleic acids.

Lightman et al. 1989Endocrinologycited by 134

PMID 2785027DOI 10.1210/endo-124-5-2358PUB-02785027

Full text at the publisher
Publisher page

PubMed tag: none · 1987

Oxytocin reduces metyrapone-induced ACTH secretion in human subjects.

Chiodera et al. 1987Brain researchcited by 18

PMID 2823973DOI 10.1016/0006-8993(87)90257-5PUB-02823973

Full text at the publisher
Publisher page

PubMed tag: none · 1984

Dose-response relationship between plasma oxytocin and cortisol and adrenocorticotropin concentrations during oxytocin infusion in normal men.

Legros et al. 1984The Journal of clinical endocrinology and metabolismcited by 60

PMID 6315753DOI 10.1210/jcem-58-1-105PUB-06315753

Full text at the publisher
Publisher page

PubMed tag: none · 1982

Inhibitory influence of exogenous oxytocin on adrenocorticotropin secretion in normal human subjects.

Legros et al. 1982The Journal of clinical endocrinology and metabolismcited by 48

PMID 6290521DOI 10.1210/jcem-55-6-1035PUB-06290521

Full text at the publisher
Publisher page

Other registry references

References listed at the registry that are not in PepBank. They link to PubMed.

  • DerivedBertolini F, Robertson L, Bisson JI, Meader N, Churchill R, Ostuzzi G, Stein DJ, Williams T, Barbui C. Early pharmacological interventions for universal prevention of post-traumatic stress disorder (PTSD). Cochrane Database Syst Rev. 2022 Feb 10;2(2):CD013443. doi: 10.1002/14651858.CD013443.pub2. PMID 35141873

Eligibility

Who could join, as posted.

Sex
All
Age
from 18 Years up to 67 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria: 1. Persons over the age of 18, who have been exposed to an event meeting the DSM-IV "A.1" criterion for trauma exposure, expressing marked anxiety, and/ or emotional distress and/or dissociation, as assessed by the Visual Analog Scales 2. The traumatic event occured up to six hour prior to the arrival to the emergency room 3. The person can and is willing to provide written, informed consent to participate in the study. Exclusion Criteria: 1. Physical injury that would contraindicate participation or interfere with a subject's ability to give informed consent or cooperate with the screening or collection of initial measures. Examples include severe burn injury, life-threatening medical or surgical condition, condition requiring surgical intervention under general anesthesia, as indicated by Abbreviated Injury Scale (AIS), or by clinical judgment; 2. Head injury involving confusion, loss of consciousness, or amnesia; 3. Medical conditions in which oxytocin administration might cause harm to the patient such as patients with a cardiovascular disease or intracranial mass. 4. Weight below 45 or above 100 kg. 5. Pregnancy (in suggestive cases, a pregnancy test will be performed); 6. Traumatic exposure that reflects ongoing victimization (e.g., domestic violence) to which the subject is likely to be re-exposed during the study period. 7. Overt psychopathology, intoxication, or under the influence of substances. 8. Evidence or history of schizophrenia, bipolar, other psychotic condition, autism; 9. Prior history of PTSD; 10. Current or past history of dementia, amnesia, or other cognitive disorder predating trauma exposure; 11. Assessed serious suicide risk.

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