title: A randomized clinical trial of lithium in multiple system atrophy.
abstract: The aim of our study was to test the safety and tolerability of lithium in multiple system atrophy (MSA). The study was randomized, placebo-controlled, and double-blind. The primary endpoint of the study was safety and tolerability. An interim analysis, performed 1 year after the first patient was randomized, showed a higher proportion of trial abandon (P < 0.01) and a higher number of adverse events (P < 0.02) in the lithium group. The trial was stopped by the Data Monitoring Committee. Overall, lithium was not well tolerated, and we do not encourage future studies with lithium in MSA patients.
authors.affiliation: Department of Neurological Sciences, University Federico II, Via Pansini, 5, 80131 Naples, Italy. francesco.sacca@unina.it
authors.forename: Francesco
authors.initials: F
authors.lastname: Saccà
authors.forename: Angela
authors.initials: A
authors.lastname: Marsili
authors.forename: Mario
authors.initials: M
authors.lastname: Quarantelli
authors.forename: Vincenzo
authors.initials: V
authors.lastname: Brescia Morra
authors.forename: Arturo
authors.initials: A
authors.lastname: Brunetti
authors.forename: Rosa
authors.initials: R
authors.lastname: Carbone
authors.forename: Chiara
authors.initials: C
authors.lastname: Pane
authors.forename: Giorgia
authors.initials: G
authors.lastname: Puorro
authors.forename: Cinzia Valeria
authors.initials: CV
authors.lastname: Russo
authors.forename: Elena
authors.initials: E
authors.lastname: Salvatore
authors.forename: Tecla
authors.initials: T
authors.lastname: Tucci
authors.forename: Giuseppe
authors.initials: G
authors.lastname: De Michele
authors.forename: Alessandro
authors.initials: A
authors.lastname: Filla
mesh_terms: D000368:Aged; D018692:Antimanic Agents / Q000627:therapeutic use*; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D008094:Lithium / Q000627:therapeutic use*; D008297:Male; D008875:Middle Aged; D019578:Multiple System Atrophy / Q000188:drug therapy*; D018709:Statistics, Nonparametric; D016896:Treatment Outcome
chemical_list: D018692:Antimanic Agents; D008094:Lithium