title: A 12-month prospective, observational study evaluating the impact of disease-modifying treatment on emotional burden in recently-diagnosed multiple sclerosis patients: The POSIDONIA study.
abstract: BACKGROUND
  Depression and anxiety are common among patients with multiple sclerosis (MS) and are frequently present at the time of MS diagnosis.
  
  
  METHODS
  POSIDONIA was a 12-month, observational, prospective study conducted in Italy to evaluate the impact of disease-modifying treatment (DMT) on emotional burden in patients with recently-diagnosed MS. The Hospital Anxiety and Depression Scale (HADS), specifically HADS anxiety (HADS-A) and depression (HADS-D) subscale scores, the Short-Form 36 Health Survey (SF-36) and the Impact of Event Scale - Revised (IES-R) were used to measure patient-reported outcomes. The Hamilton Depression Rating Scale (HDRS), HDRS-17, was used as a measure of healthcare provider-reported outcomes. The primary study outcome was change from baseline in feelings of anxiety and depression over 12months (via HADS).
  
  
  RESULTS
  Of 250 enrolled patients, 222 (88.8%) completed the study. At baseline, mean HADS total, HADS-A and HADS-D subscale scores were within the normal range. There were no significant changes over time in mean HADS total and HADS-A and HADS-D subscale scores, although the subgroup of patients with baseline scores indicative of anxiety or depression tended to improve over time. Both the HDRS and IES-R total scores improved over time, but there were no statistically significant changes in SF-36.
  
  
  CONCLUSIONS
  In the patient population of the POSIDONIA study depression and anxiety were present in a minority of patients thus not allowing to detect the impact of starting DMT. However DMT appears to have a positive effect in patients with measurable anxiety or depression at baseline.
authors.affiliation: Azienda USL di Parma - Ospedale di Fidenza, Fidenza, Italy. Electronic address: emontanari@ausl.pr.it.
authors.forename: Enrico
authors.initials: E
authors.lastname: Montanari
authors.affiliation: Centro Sclerosi Multipla, Ospedale Papa Giovanni XXIII, Bergamo, Italy.
authors.forename: Mariarosa
authors.initials: M
authors.lastname: Rottoli
authors.affiliation: Centro Sclerosi Multipla, U.O. Neurologia, Azienda Ospedaliera Garibaldi, Catania, Italy.
authors.forename: Davide
authors.initials: D
authors.lastname: Maimone
authors.affiliation: Centro Sclerosi Multipla, U.O Neurologia IV, Fondazione Istituto Neurologico Carlo Besta, Milano, Italy.
authors.forename: Paolo
authors.initials: P
authors.lastname: Confalonieri
authors.affiliation: Ospedale Misericordia di Grosseto, Grosseto, Italy.
authors.forename: Katrin
authors.initials: K
authors.lastname: Plewnia
authors.affiliation: Clinica Neurologica, Ospedale San Gerardo, Monza, Italy.
authors.forename: Maura
authors.initials: M
authors.lastname: Frigo
authors.affiliation: Centro Sclerosi Multipla Azienda Policlinico Umberto I, Roma, Italy.
authors.forename: Ada
authors.initials: A
authors.lastname: Francia
authors.affiliation: U.O. di Neurologia Ospedaliera, Presidio Ospedaliero A. Segni, Ozieri, Italy.
authors.forename: Antonello
authors.initials: A
authors.lastname: Pala
authors.affiliation: U.O Neurologia, Presidio Ospedaliero Dimiccoli, Barletta, Italy.
authors.forename: Nunzia Alessandra
authors.initials: NA
authors.lastname: Losignore
authors.affiliation: Department of Experimental Biomedicine and Clinical Neuroscience, University of Palermo, Palermo, Italy.
authors.forename: Paolo
authors.initials: P
authors.lastname: Ragonese
authors.affiliation: Medical Department, Teva Italia, Milano, Italy.
authors.forename: Antonella
authors.initials: A
authors.lastname: Veneziano
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D005260:Female; D006801:Humans; D007155:Immunologic Factors / Q000627:therapeutic use*; D007558:Italy; D016015:Logistic Models; D008297:Male; D008875:Middle Aged; D019964:Mood Disorders / Q000209:etiology*; D009103:Multiple Sclerosis / Q000150:complications* / Q000188:drug therapy*; D011446:Prospective Studies; D011569:Psychiatric Status Rating Scales; D011594:Psychometrics; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D007155:Immunologic Factors
keywords: Anxiety; Depression; Disease-modifying treatment; Emotional burden; Multiple sclerosis