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Neurology. 2015 Jan 13;84(2):174-81. doi: 10.1212/WNL.0000000000001133. Epub 2014 Dec 10.

Oxytocin for frontotemporal dementia: a randomized dose-finding study of safety and tolerability.

Author information

1
From the Departments of Clinical Neurological Sciences (E.C.F., J.M., M.B., S.J., S.P., A.K.), Medicine (M.B., J.W.), Psychiatry (D.G.V.M.), and Anatomy and Cell Biology (D.G.V.M.), and Graduate Program in Neuroscience (L.D.O.), Schulich School of Medicine and Dentistry, Western University, London, Ontario; Tanz Centre for Research in Neurodegenerative Disease (M.C.T.), University of Toronto, Canada; Freie Universität Berlin (I.D.), Cluster of Excellence Languages of Emotion, Berlin, Germany; and Department of Neurology (K.R., A.B.), University of California San Francisco School of Medicine. Elizabeth.Finger@lhsc.on.ca.
2
From the Departments of Clinical Neurological Sciences (E.C.F., J.M., M.B., S.J., S.P., A.K.), Medicine (M.B., J.W.), Psychiatry (D.G.V.M.), and Anatomy and Cell Biology (D.G.V.M.), and Graduate Program in Neuroscience (L.D.O.), Schulich School of Medicine and Dentistry, Western University, London, Ontario; Tanz Centre for Research in Neurodegenerative Disease (M.C.T.), University of Toronto, Canada; Freie Universität Berlin (I.D.), Cluster of Excellence Languages of Emotion, Berlin, Germany; and Department of Neurology (K.R., A.B.), University of California San Francisco School of Medicine.

Abstract

OBJECTIVE:

To determine the safety and tolerability of 3 doses of intranasal oxytocin (Syntocinon; Novartis, Bern, Switzerland) administered to patients with frontotemporal dementia (FTD).

METHODS:

We conducted a randomized, parallel-group, double-blind, placebo-controlled study using a dose-escalation design to test 3 clinically feasible doses of intranasal oxytocin (24, 48, or 72 IU) administered twice daily for 1 week to 23 patients with behavioral variant FTD or semantic dementia (clinicaltrials.gov registration number NCT01386333). Primary outcome measures were safety and tolerability at each dose. Secondary measures explored efficacy across the combined oxytocin vs placebo groups and examined potential dose-related effects.

RESULTS:

All 3 doses of intranasal oxytocin were safe and well tolerated.

CONCLUSIONS:

A multicenter trial is warranted to determine the therapeutic efficacy of long-term intranasal oxytocin for behavioral symptoms in FTD.

CLASSIFICATION OF EVIDENCE:

This study provides Class I evidence that for patients with FTD, intranasal oxytocin is not significantly associated with adverse events or significant changes in the overall neuropsychiatric inventory.

PMID:
25503617
PMCID:
PMC4336088
DOI:
10.1212/WNL.0000000000001133
[Indexed for MEDLINE]
Free PMC Article

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