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Trial · Interventional

CompletedPhase 2Registry data

Impact of Emotional Mimicry and Oxytocin on Frontotemporal Dementia

Short name IEMO

NCTNCT01937013 (opens ClinicalTrials.gov in a new tab)Other idR-13-270Other id166786Other id103555Other idFTDOXY13EF
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Completed
Phase
Phase 2
Enrollment
52 participants (actual)
Sponsor
London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's · Other
Design
Randomized · Quadruple masking
Countries
1 country

Canada

Start
12 Sept 2013
Primary completion
21 Dec 2017
Completion
21 Dec 2017
First posted
9 Sept 2013 (estimated)
Last update posted
8 Aug 2018
Conditions
Frontotemporal Dementia

Timeline

1 trial · 1 completed

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
201320142015201620172018
  1. Ph 2

    IEMO

    NCT01937013

    12 Sept 2013 to 21 Dec 2017

Registry summary

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

This study will evaluate the effects on emotions and neural activity of a one time dose of intranasal oxytocin vs. placebo in patients with FTD and healthy controls.

Interventions

  • Intranasal oxytocinDrug
  • Saline Nasal MistDrug

Arms2

  • Experimental

    Intranasal Oxytocin

    Participants will be randomized to receive 72 IU intranasal oxytocin on either study visit 2 or 3

  • Placebo comparator

    Saline Nasal Mist

    Participants will be randomized to receive intranasal saline mist (placebo) on opposite visits from the interventional drug visit 2 or 3

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Functional magnetic resonance imaging (fMRI) BOLD signal

    Time frame · 2 weeks

    Registry description

    Measures of BOLD (Blood Oxygen-Level Dependent) signal change during oxytocin compared to placebo during functional MRI scans

Secondary outcomes(1)

  1. Cognitive and Emotional Task performance

    Time frame · 2 weeks

    Registry description

    Performance on standardized tasks of emotion processing and cognition

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

Studies1

Studies that cite this trial.

Studies with results

1 study on this page

Indexing hint: Randomized controlled trial · 2020

2 results

Neural effects of oxytocin and mimicry in frontotemporal dementia: A randomized crossover study.

Oliver et al. 2020Neurologycited by 22

PMID 32963103PMC7713736DOI 10.1212/wnl.0000000000010933PUB-32963103

Rights unknown2 results
Source linkSee results (2)

Eligibility

Who could join, as posted.

Sex
All
Age
from 30 Years up to 85 Years
Healthy volunteers
Accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria: Patients: * Ages 30-85 * meet consensus criteria for probable behavioural variant FTD (bvFTD) Controls: * Age and sex matched with patients * Mini-Mental State Exam (MMSE) scores \>27 Exclusion Criteria: Patients: * history of stroke * intracranial haemorrhage or other medical or neurological disorder apart from FTD that could affect cognition * diagnosis of bipolar disorder or schizophrenia not better accounted for by the diagnosis of FTD * cognitive impairment that precludes comprehension of task instructions * contraindication to MRI scanning * severe language or memory deficits that preclude participation in the study visits and measures * females who are pregnant or breastfeeding (a pregnancy test will be done on females who have not completed menopause). * uncontrolled hypertension * bradycardia (rate \<48 bpm) or tachycardia (rate \> 100 bpm) * current use of prostaglandins Controls: * history of stroke * intracranial haemorrhage or other medical or neurological disorder * diagnosis of bipolar disorder or schizophrenia * cognitive impairment that precludes comprehension of task instructions * contraindication to MRI scanning * severe language or memory deficits that preclude participation in the study visits and measures * females who are pregnant or breastfeeding (a pregnancy test will be done on females who have not completed menopause). * uncontrolled hypertension * bradycardia (rate \<48 bpm) or tachycardia (rate \> 100 bpm) * current use of prostaglandins

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