title: Agitation predicts response of depression to botulinum toxin treatment in a randomized controlled trial.
abstract: In a randomized, controlled trial (n = 30), we showed that botulinum toxin injection to the glabellar region produces a marked improvement in the symptoms of major depression. We hypothesized that the mood-lifting effect was mediated by facial feedback mechanisms. Here we assessed if agitation, which may be associated with increased dynamic psychomotor activity of the facial musculature, can predict response to the treatment. To test this hypothesis, we re-analyzed the data of the scales from our previous study on a single item basis and compared the baseline scores in the agitation item (item 9) of the Hamilton Depression Rating Scale (HAM-D) between responders (n = 9) and participants who did not attain response (n = 6) among the recipients of onabotulinumtoxinA (n = 15). Responders had significantly higher item 9 scores at baseline [1.56 + 0.88 vs. 0.33 + 0.52, t (13) = 3.04, d = 1.7, p = 0.01], while no other single item of the HAM-D or the Beck Depression Inventory was associated with treatment response. The agitation score had an overall precision of 78% in predicting response in a receiver operating characteristic (ROC) analysis (area under the curve, AUC = 0.87). These data provide a link between response to botulinum toxin treatment with a psychomotor manifestation of depression and thereby indirect support of the proposed facial feedback mechanism of action. Moreover, it suggests that patients with agitated depression may particularly benefit from botulinum toxin treatment.
authors.affiliation: Asklepios Clinic North - Ochsenzoll, Asklepios Campus Hamburg, Medical Faculty, Semmelweis University , Hamburg , Germany ; Psychiatric Clinics of the University of Basel , Basel , Switzerland.
authors.forename: M Axel
authors.initials: MA
authors.lastname: Wollmer
authors.affiliation: Psychiatric Clinics of the University of Basel , Basel , Switzerland.
authors.forename: Nadeem
authors.initials: N
authors.lastname: Kalak
authors.affiliation: Asklepios Clinic North - Ochsenzoll, Asklepios Campus Hamburg, Medical Faculty, Semmelweis University , Hamburg , Germany ; Department of Psychiatry, Social Psychiatry and Psychotherapy, Medical School Hannover , Hannover , Germany.
authors.forename: Stefanie
authors.initials: S
authors.lastname: Jung
authors.affiliation: Department of Psychiatry, Social Psychiatry and Psychotherapy, Medical School Hannover , Hannover , Germany.
authors.forename: Claas
authors.initials: C
authors.lastname: de Boer
authors.affiliation: Department of Psychiatry, University of Texas Southwestern at Seton Family of Hospitals , Austin, TX , USA.
authors.forename: Michelle
authors.initials: M
authors.lastname: Magid
authors.affiliation: Department of Dermatology, University of Texas Southwestern at Seton Family of Hospitals , Austin, TX , USA.
authors.forename: Jason S
authors.initials: JS
authors.lastname: Reichenberg
authors.affiliation: Psychiatric Clinics of the University of Basel , Basel , Switzerland.
authors.forename: Serge
authors.initials: S
authors.lastname: Brand
authors.affiliation: Psychiatric Clinics of the University of Basel , Basel , Switzerland.
authors.forename: Edith
authors.initials: E
authors.lastname: Holsboer-Trachsler
authors.affiliation: Department of Psychiatry, Social Psychiatry and Psychotherapy, Medical School Hannover , Hannover , Germany.
authors.forename: Tillmann H C
authors.initials: TH
authors.lastname: Kruger
keywords: major depressive disorder; personalized medicine; psychomotor agitation; randomized controlled trial; type A botulinum toxins
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