title: Oxytocin for frontotemporal dementia: a randomized dose-finding study of safety and tolerability.
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.
  
  
  METHODS
  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.
authors.affiliation: 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.
authors.forename: Elizabeth C
authors.initials: EC
authors.lastname: Finger
authors.affiliation: 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.
authors.forename: Julia
authors.initials: J
authors.lastname: MacKinley
authors.affiliation: 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.
authors.forename: Mervin
authors.initials: M
authors.lastname: Blair
authors.affiliation: 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.
authors.forename: Lindsay D
authors.initials: LD
authors.lastname: Oliver
authors.affiliation: 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.
authors.forename: Sarah
authors.initials: S
authors.lastname: Jesso
authors.affiliation: 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.
authors.forename: Maria C
authors.initials: MC
authors.lastname: Tartaglia
authors.affiliation: 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.
authors.forename: Michael
authors.initials: M
authors.lastname: Borrie
authors.affiliation: 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.
authors.forename: Jennie
authors.initials: J
authors.lastname: Wells
authors.affiliation: 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.
authors.forename: Isabel
authors.initials: I
authors.lastname: Dziobek
authors.affiliation: 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.
authors.forename: Stephen
authors.initials: S
authors.lastname: Pasternak
authors.affiliation: 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.
authors.forename: Derek G V
authors.initials: DG
authors.lastname: Mitchell
authors.affiliation: 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.
authors.forename: Katherine
authors.initials: K
authors.lastname: Rankin
authors.affiliation: 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.
authors.forename: Andrew
authors.initials: A
authors.lastname: Kertesz
authors.affiliation: 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.
authors.forename: Adam
authors.initials: A
authors.lastname: Boxer
mesh_terms: D000281:Administration, Intranasal; D000368:Aged; D000369:Aged, 80 and over; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D004644:Emotions; D004645:Empathy; D005260:Female; D057180:Frontotemporal Dementia / Q000188:drug therapy* / Q000523:psychology; D006801:Humans; D008297:Male; D008875:Middle Aged; D010121:Oxytocin / Q000008:administration & dosage* / Q000009:adverse effects; D016896:Treatment Outcome
chemical_list: D010121:Oxytocin