Clinical Trial: Safety Study of Intranasal Oxytocin in Frontotemporal Dementia

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: A Phase I Dose Finding Study of Intranasal Oxytocin in Frontotemporal Dementia, Protocol # FTDOXY10EF

Brief Summary: Oxytocin is a hormone produced by the brain that appears to have important roles in social cognition and emotion in humans. In a pilot study, the effects of a single dose of oxytocin on measures of emotion recognition and behaviour in patients with Frontotemporal Dementia were investigated. The results from the pilot study suggested that oxytocin may be associated with a modest improvement in neuropsychiatric behaviours seen in patients with Frontotemporal Dementia. To further examine the safety and tolerability of oxytocin in this disorder, the present study will examine the safety and tolerability of three different doses of intranasal oxytocin administered to patients with Frontotemporal Dementia twice daily for 1 week.

Detailed Summary:
Sponsor: Lawson Health Research Institute

Current Primary Outcome: Number of Participants with Adverse Events as a Measure of Safety and Tolerability [ Time Frame: 2 week ]

Safety and Tolerability of 24 international units (IU), 48 IU and 72 IU of intranasal oxytocin administered twice daily for 1 week to patients with Frontotemporal Dementia as assessed by the number of participants with adverse events. Adverse events will be assessed by a standardized questionnaire and serum sodium levels will be monitored.


Original Primary Outcome: Number of Participants with Adverse Events as a Measure of Safety and Tolerability [ Time Frame: 2 week ]

Safety and Tolerability of 24 international units (IU), 48 IU and 72 IU of intranasal oxytocin administered twice daily for 1 week to patients with Frontotemporal Dementia as assessed by the number of participants with adverse events. Adverse events will be asssessed by a standardized questionaire and serum sodium levels will be monitored.


Current Secondary Outcome:

  • Neuropsychiatric Inventory [ Time Frame: 1 week ]
    Behavioural ratings at baseline and 1 week of oxytocin treatment compared to 1 week of placebo treatment
  • Frontal Behavioural Inventory [ Time Frame: 1 week ]
  • Clinicians Global Impression of Change [ Time Frame: 1 week ]
  • Clinical Dementia Rating- Frontotemporal Lobar Degeneration [ Time Frame: 1 week ]
  • Interpersonal Reactivity Index [ Time Frame: 1 week ]
  • Multi-faceted Empathy Test [ Time Frame: 1 week ]


Original Secondary Outcome: Same as current

Information By: Lawson Health Research Institute

Dates:
Date Received: June 29, 2011
Date Started: June 2011
Date Completion:
Last Updated: November 1, 2013
Last Verified: November 2013