title: Duloxetine is effective in treating depression in multiple sclerosis patients: an open-label multicenter study.
abstract: OBJECTIVE
  Duloxetine hydrochloride, a dual reuptake inhibitor of serotonin and norepinephrine, was evaluated for its therapeutic efficacy, safety, and tolerability in the treatment of depression in patients with multiple sclerosis (MS). Lifetime depression prevalence approaches 50% in MS patients. The aim of the study was to assess the safety and efficacy of duloxetine for treatment of depression in MS patients.
  
  
  METHODS
  An open-label study evaluated the efficacy of 12 weeks of duloxetine administration (maximal dose = 60 mg/d) in MS patients with clinical depression. The Beck scale score variation after 4 (T1) and 12 (T2) weeks of treatment was used for the primary outcome measurement, whereas secondary outcome was measured using the Modified Fatigue Impact Scale. Safety was evaluated by recording treatment-related adverse events, monitoring vital signs, and recording frequency and reasons for interruption or discontinuation of treatment.
  
  
  RESULTS
  Seventy-five patients were enrolled in the study. Sixty-three patients completed the study by continuing duloxetine treatment for 12 weeks (T2). Twelve subjects dropped out of the study because of adverse effects or noncompliance. Nausea was the most common adverse event reported. A significant reduction in the Beck Depression Inventory and Modified Fatigue Impact Scale scores, after both 4 and 12 weeks of therapy, was observed.
  
  
  CONCLUSIONS
  The results suggest that duloxetine is well tolerated, safe, and effective in reducing depression and fatigue in MS patients.
authors.affiliation: Department Head-Neck UO Neurology ASL 3 Genovese, Genova, Italy. csolaro@libero.it
authors.forename: Claudio
authors.initials: C
authors.lastname: Solaro
authors.forename: Roberto
authors.initials: R
authors.lastname: Bergamaschi
authors.forename: Cristiana
authors.initials: C
authors.lastname: Rezzani
authors.forename: Margit
authors.initials: M
authors.lastname: Mueller
authors.forename: Erika
authors.initials: E
authors.lastname: Trabucco
authors.forename: Valeria
authors.initials: V
authors.lastname: Bargiggia
authors.forename: Francesca
authors.initials: F
authors.lastname: Dematteis
authors.forename: Alessandra
authors.initials: A
authors.lastname: Mattioda
authors.forename: Vincenzo
authors.initials: V
authors.lastname: Cimino
authors.forename: Domenico
authors.initials: D
authors.lastname: Restivo
authors.forename: Francesco
authors.initials: F
authors.lastname: Patti
authors.forename: Paola
authors.initials: P
authors.lastname: Cavalla
mesh_terms: D018759:Adrenergic Uptake Inhibitors / Q000009:adverse effects / Q000627:therapeutic use*; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000928:Antidepressive Agents / Q000009:adverse effects / Q000627:therapeutic use*; D003863:Depression / Q000188:drug therapy*; D039721:Diagnostic and Statistical Manual of Mental Disorders; D016903:Drug Monitoring; D000068736:Duloxetine Hydrochloride; D005221:Fatigue / Q000209:etiology / Q000517:prevention & control; D005260:Female; D006801:Humans; D007166:Immunosuppressive Agents / Q000627:therapeutic use; D008297:Male; D008875:Middle Aged; D009103:Multiple Sclerosis / Q000188:drug therapy / Q000503:physiopathology / Q000523:psychology*; D020529:Multiple Sclerosis, Relapsing-Remitting / Q000188:drug therapy / Q000503:physiopathology / Q000523:psychology; D009325:Nausea / Q000139:chemically induced; D010352:Patient Dropouts; D017367:Selective Serotonin Reuptake Inhibitors / Q000009:adverse effects / Q000627:therapeutic use*; D013876:Thiophenes / Q000009:adverse effects / Q000627:therapeutic use*
chemical_list: D018759:Adrenergic Uptake Inhibitors; D000928:Antidepressive Agents; D000068736:Duloxetine Hydrochloride; D007166:Immunosuppressive Agents; D017367:Selective Serotonin Reuptake Inhibitors; D013876:Thiophenes