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