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Trial · Interventional

CompletedNot applicableResults postedRegistry data

Effect of Intranasal Neuropeptide on Emotion Perception in Trait Anxiety

NCTNCT01551303 (opens ClinicalTrials.gov in a new tab)Other id2009P-000387
Open at ClinicalTrials.govAsk about this trial

Overview

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

United States

Start
Feb 2009
Primary completion
Dec 2012
Completion
Dec 2012
First posted
12 Mar 2012 (estimated)
Last update posted
30 Jun 2014 (estimated)
Conditions
Social Intelligence

Timeline

1 trial · 1 completed · 1 with posted results

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
20092010201120122013
  1. N/A

    Effect of Intranasal Neuropeptide on Emotion Perception in Trait Anxiety

    NCT01551303

    Feb 2009 to Dec 2012

Registry summary

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

The purpose of this study is to learn more about how emotional processing may be affected by a hormone called oxytocin. Oxytocin is a hormone that occurs naturally in the body, and may play an important role in the way that the brain perceives information.

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. Affective Ratings in Affective Learning Task

    Time frame · 30 minutes after drug administration

    Registry description

    We will measure the effect of the drug on affective learning, using the Affective Learning Task. Participants viewed 30 neutral faces, each paired with one sentence describing a negative positive, or neutral behavior, counterbalanced across participants. During the test phase, participants will rate the faces as negative, neutral, or positive. These ratings were averaged. Responses were coded as: negative = -1, neutral = 0, positive =1, so the averaged scores have a possible range between -1 and 1. Since this is not a treatment study for a disease, there is so "better" or "worse" outcome.

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· 30 minutes after drug administration

Affective Ratings in Affective Learning Task

GroupValue (units on a scale)Spread
Oxytocin-0.0960.05
Placebo-0.120.054

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 / 220 / 22
OxytocinLiquid intranasal oxytocin administered in a nasal spray. Oxytocin: Liquid metered-dose nasal spray, 30 IUs, administered once.–0 / 251 / 25

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: * No current Axis I according to Diagnostic \& Statistical Manual for Psychiatry-IV excluded diagnoses as determined by MINI or Structured Clinical Interview for Diagnosis psychiatric diagnostic interview completed within the past 6 months * Age 18 to 65 * Subjects must be able to give informed consent and be willing and able to comply with study procedures. Exclusion Criteria: * Patients with severe unstable medical illness, clinically significant laboratory findings, or serious medical illness for which hospitalization may be likely within the next three months * Pregnant or lactating women. * Subjects currently taking hormones, such as estrogen. * Known hypersensitivity to oxytocin or to any of the excipients of Syntocinon Nasal spray. * Known hyponatremia or concurrent use of diuretics. * Subjects with a history of seizure disorder.

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