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Trial · Interventional

CompletedNot applicableRegistry data

Oxytocin and Social Cognition in Frontotemporal Dementia

NCTNCT01002300 (opens ClinicalTrials.gov in a new tab)Other idR-08-395Other id15398
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Completed
Phase
Not applicable
Enrollment
24 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
Sept 2009
Primary completion
Nov 2010
Completion
Nov 2010
First posted
27 Oct 2009 (estimated)
Last update posted
18 Mar 2014 (estimated)
Conditions
Frontotemporal Dementia · Pick's Disease

Timeline

1 trial · 1 completed

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
200920102011
  1. N/A

    Oxytocin and Social Cognition in Frontotemporal Dementia

    NCT01002300

    Sept 2009 to Nov 2010

Registry summary

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

Investigations into the components of cognition damaged in frontotemporal dementia (FTD) demonstrate that patients with FTD show deficits in facial and verbal expression recognition, lack insight into what others think or might do (theory of mind skills), and in decision making tasks requiring processing of positive versus negative feedback. These cognitive functions are thought to be critical for appropriate social behavioural regulation (Blair, 2003). Recent studies in animal models and humans suggest that the neuropeptide oxytocin is an important mediator of social behavior and that oxytocin may facilitate emotion recognition, theory of mind processing, and prosocial behaviors (Donaldson and Young, 2008). Together, these findings suggest that upregulation of oxytocin dependent mechanisms of social and emotional cognition may be a valuable treatment approach in patients with FTD. The aim of this study is to determine how administration of intranasal oxytocin to patients with frontotemporal dementia affects behavior and processing of specific types of social and emotional information.The investigators' hypothesis is that oxytocin administration will improve emotional and social cognitive deficits in patients with FTD, resulting in improved decision making and behaviour.

Interventions

  • intranasal oxytocinDrug

Arms0

The registry lists no arms for this trial.

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Performance on Emotion Recognition Tasks

    Time frame · Day of treatment

Secondary outcomes(2)

  1. Behavioural Ratings of Emotional Sensitivity and Repetitive Behaviours

    Time frame · One week following treatment

  2. Side effects

    Time frame · 1 week after treatment

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

Studies3

Studies that cite this trial.

Studies with results

2 studies on this page

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 · 2007

2 results

Oxytocin increases retention of social cognition in autism.

Hollander et al. 2007Biological psychiatrycited by 471

PMID 16904652DOI 10.1016/j.biopsych.2006.05.030PUB-16904652

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

More studies

1 study on this page

Indexing hint: Review · 2008

Oxytocin, vasopressin, and the neurogenetics of sociality.

Donaldson et al. 2008Science (New York, N.Y.)cited by 1,108

PMID 18988842DOI 10.1126/science.1158668PUB-18988842

Full text at the publisher
Publisher page

Eligibility

Who could join, as posted.

Sex
All
Age
from 30 Years up to 80 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria: * Clinical diagnosis of probable Frontotemporal Dementia or Pick's disease * Caregiver available to participate in all study visits Exclusion Criteria: * Severe language or memory deficits that preclude completion of the cognitive tasks * Females who are pregnant or breastfeeding (a pregnancy test will be done on females who have not completed menopause) * Uncontrolled hypertension * Bradycardia (rate \<50 bpm) or tachycardia (rate \> 100 bpm) * Current use of prostaglandins * Use of any investigational or experimental drug or device within the last 60 days prior to screening or within 5 half-lives of the experimental drug , whichever is longer

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