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Trial · Interventional

CompletedNot applicableResults postedRegistry data

The Effect of Oxytocin on Fear Memory Consolidation Novel Intervention to Prevent Posttraumatic Stress Disorder (PTSD)

NCTNCT01466127 (opens ClinicalTrials.gov in a new tab)Other id2010P-002911
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Completed
Phase
Not applicable
Enrollment
60 participants (actual)
Sponsor
Massachusetts General Hospital · Other
Design
Randomized · Double masking
Countries
1 country

United States

Start
Oct 2011
Primary completion
May 2014
Completion
May 2014
First posted
7 Nov 2011 (estimated)
Last update posted
14 Apr 2017
Conditions
Posttraumatic Stress Disorder

Timeline

1 trial · 1 completed · 1 with posted results

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
20112012201320142015
  1. N/A

    The Effect of Oxytocin on Fear Memory Consolidation Novel Intervention to Prevent Posttraumatic Stress Disorder (PTSD)

    NCT01466127

    Oct 2011 to May 2014

Registry summary

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

The purpose of the study is to learn how differences in learning under mildly-stressful circumstances may be changed by taking oxytocin. Oxytocin is a hormone made naturally in the body. The investigators will also examine the impact of any anxiety, depression, and stress related symptoms on learning processes.

Interventions

  • OxytocinDrug
  • PlaceboDrug

Arms2

  • Placebo comparator

    Placebo

    Matched nasal spray placebo.

  • Experimental

    Oxytocin

    Liquid intranasal oxytocin administered in a nasal spray.

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Differential Skin Conductance Response (SCR) During the First Two Extinction Trials

    Time frame · Day 2 of Conditioning (1 day post Day 1 of Conditioning)

    Registry description

    Differences in skin conductance response (SCR) between the active vs. placebo conditions trials will be used to assess for the impact of oxytocin on fear acquisition and extinction. We will take a mean of the first two extinction trials to get this measure. Data was gathered in micro-Siemens and then underwent a square root transformation.

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· Day 2 of Conditioning (1 day post Day 1 of Conditioning)

Differential Skin Conductance Response (SCR) During the First Two Extinction Trials

GroupValue (micro-Siemens (square rooted))Spread
Placebo0.150.31
Oxytocin0.000.39

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
GroupDeathsSerious eventsOther events
PlaceboMatched nasal spray placebo. Placebo: Matched nasal spray placebo–0 / 161 / 16
OxytocinLiquid intranasal oxytocin administered in a nasal spray. Oxytocin: Liquid metered-dose nasal spray, 30 IUs, administered once.–0 / 140 / 14

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

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex
All
Age
from 18 Years up to 65 Years
Healthy volunteers
Accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria: * Men or women 18 to 65 years of age * Score in study range on the Neuroticism-Extraversion-Openness-Five Factor Inventory (NEO-FFI) * No current Axis I Diagnostic and Statistical Manual-IV (DSM) excluded diagnoses as determined by the Structured Clinical Interview DSM (SCID) completed within the past 4 months. * Must be able and willing to understand study procedures and return to the clinic on two separate consecutive days for the fear-conditioning procedures. * Subjects must be able to give informed consent and be willing and able to comply with study procedures. Exclusion Criteria: * Presence of a current DSM-IV Axis I diagnosis as measured by the SCID. * A serious medical condition or other condition deemed likely to result in surgery or hospitalization, or which would make participation in the study difficult. * Patients with a history of trauma resulting in head injury related seizures or with epilepsy (except a prior history of febrile seizures of infancy which are not exclusionary). * Use of supplemental hormones (birth control, estrogen, testosterone, prednisone, etc) or narcotics. * Pregnant or lactating women. * Women of childbearing potential not using medically accepted forms of contraception. * Current use of the excluded psychiatric medications. * Known hypersensitivity to oxytocin * Known hyponatremia.

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