NCT01937013

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
52

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Sep 2013

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 3, 2013

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 9, 2013

Completed
3 days until next milestone

Study Start

First participant enrolled

September 12, 2013

Completed
4.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 21, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 21, 2017

Completed
Last Updated

August 8, 2018

Status Verified

August 1, 2018

Enrollment Period

4.3 years

First QC Date

September 3, 2013

Last Update Submit

August 7, 2018

Conditions

Frontotemporal Dementia

Keywords

Frontotemporal DementiaemotionoxytocinfMRI

Outcome Measures

Primary Outcomes (1)

  • Functional magnetic resonance imaging (fMRI) BOLD signal

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

    2 weeks

Secondary Outcomes (1)

  • Cognitive and Emotional Task performance

    2 weeks

Study Arms (2)

Intranasal Oxytocin

EXPERIMENTAL

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

Drug: Intranasal oxytocin

Saline Nasal Mist

PLACEBO COMPARATOR

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

Drug: Saline Nasal Mist

Interventions

Intranasal oxytocinDRUG

Oxytocin can be given intravenously (with a needle) or intranasally (a spray into the nose). The intravenous form of drug is approved by Health Canada for use in pregnancy. The intranasal formulation is not currently approved for use by Health Canada, but is used in Europe to induce labour in pregnant women or aid lactation (breastfeeding). Participants will be randomized to receive 72 IU intranasal oxytocin on either study visit 2 or 3.

Also known as: Syntocinon
Intranasal Oxytocin
Saline Nasal MistDRUG

Participants will be randomized to receive placebo on either study visit 2 or 3.

Also known as: Placebo
Saline Nasal Mist

Eligibility Criteria

Age30 Years - 85 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • +7 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Parkwood Hospital

London, Ontario, N6C 5J1, Canada

Location

Related Publications (1)

  • Oliver LD, Stewart C, Coleman K, Kryklywy JH, Bartha R, Mitchell DGV, Finger EC. Neural effects of oxytocin and mimicry in frontotemporal dementia: A randomized crossover study. Neurology. 2020 Nov 10;95(19):e2635-e2647. doi: 10.1212/WNL.0000000000010933. Epub 2020 Sep 22.

    PMID: 32963103DERIVED

MeSH Terms

Conditions

Frontotemporal Dementia

Interventions

Oxytocin

Condition Hierarchy (Ancestors)

Frontotemporal Lobar DegenerationDementiaBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesTDP-43 ProteinopathiesNeurodegenerative DiseasesProteostasis DeficienciesMetabolic DiseasesNutritional and Metabolic DiseasesNeurocognitive DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Pituitary Hormones, PosteriorPituitary HormonesPeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsPeptidesAmino Acids, Peptides, and Proteins

Study Officials

  • Elizabeth C Finger, M.D.

    LawsonHRI, London Health Sciences Centre, Western University, Schulich School of Medicine

    PRINCIPAL INVESTIGATOR

  • Derek Mitchell, PhD

    Western University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principle Investigator

Study Record Dates

First Submitted

September 3, 2013

First Posted

September 9, 2013

Study Start

September 12, 2013

Primary Completion

December 21, 2017

Study Completion

December 21, 2017

Last Updated

August 8, 2018

Record last verified: 2018-08

Locations

CA(1)