title: Does lithium reduce acute suicidal ideation and behavior? A protocol for a randomized, placebo-controlled multicenter trial of lithium plus Treatment As Usual (TAU) in patients with suicidal major depressive episode.
abstract: BACKGROUND
  Lithium has proven suicide preventing effects in the long-term treatment of patients with affective disorders. Clinical evidence from case reports indicate that this effect may occur early on at the beginning of lithium treatment. The impact of lithium treatment on acute suicidal thoughts and/or behavior has not been systematically studied in a controlled trial. The primary objective of this confirmatory study is to determine the association between lithium therapy and acute suicidal ideation and/or suicidal behavior in inpatients with a major depressive episode (MDE, unipolar and bipolar disorder according to DSM IV criteria). The specific aim is to test the hypothesis that lithium plus treatment as usual (TAU), compared to placebo plus TAU, results in a significantly greater decrease in suicidal ideation and/or behavior over 5 weeks in inpatients with MDE.
  
  
  METHODS
  We initiated a randomized, placebo-controlled multicenter trial. Patients with the diagnosis of a moderate to severe depressive episode and suicidal thoughts and/or suicidal behavior measured with the Sheehan-Suicidality-Tracking Scale (S-STS) will be randomly allocated to add lithium or placebo to their treatment as usual. Change in the clinician administered S-STS from the initial to the final visit will be the primary outcome.
  
  
  CONCLUSIONS
  There is an urgent need to identify treatments that will acutely decrease suicidal ideation and/or suicidal behavior. The results of this study will demonstrate whether lithium reduces suicidal ideation and behavior within the first 5 weeks of treatment.
  
  
  BACKGROUND
  ClinicalTrials.gov identifier: NCT02039479.
authors.affiliation: Department of Psychiatry and Psychotherapy, University Hospital Carl Gustav Carus, Technische Universität Dresden, Fetscherstr. 74, Dresden, D-01307, Germany. ute.lewitzka@uniklinikum-dresden.de.
authors.forename: U
authors.initials: U
authors.lastname: Lewitzka
authors.affiliation: Psychiatric Department of the Municipal Hospital Dresden-Neustadt, Dresden, Germany. Burkhard.Jabs@khdn.de.
authors.forename: B
authors.initials: B
authors.lastname: Jabs
authors.affiliation: Psychiatric Department of the Municipal Hospital Dresden-Neustadt, Dresden, Germany. Matthias.Fuelle@khdn.de.
authors.forename: M
authors.initials: M
authors.lastname: Fülle
authors.affiliation: Department of Psychiatry, Psychotherapy and Psychosomatic Medicine, Alexianer Krankenhaus Hedwigshöhe, Berlin, Germany. v.holthoff-detto@alexius.de.
authors.forename: V
authors.initials: V
authors.lastname: Holthoff
authors.affiliation: Department of Psychiatry, Psychotherapy, Prevention Medicine, LWL-University Clinic Bochum, Ruhr University Bochum, Bochum, Germany. georg.juckel@wkp-lwl.org.
authors.forename: G
authors.initials: G
authors.lastname: Juckel
authors.affiliation: Department of Psychiatry, Psychotherapy, Prevention Medicine, LWL-University Clinic Bochum, Ruhr University Bochum, Bochum, Germany. idun.uhl@wkp-lwl.org.
authors.forename: I
authors.initials: I
authors.lastname: Uhl
authors.affiliation: Department of Psychiatry, Psychosomatic Medicine and Psychotherapy, Goethe-Universit, Frankfurt, Germany. sarah.kittel-schneider@kgu.de.
authors.forename: S
authors.initials: S
authors.lastname: Kittel-Schneider
authors.affiliation: Department of Psychiatry, Psychosomatic Medicine and Psychotherapy, Goethe-Universit, Frankfurt, Germany. andreas.reif@kgu.de.
authors.forename: A
authors.initials: A
authors.lastname: Reif
authors.affiliation: Department of Psychiatry, Psychosomatic Medicine and Psychotherapy, Goethe-Universit, Frankfurt, Germany. Christine.Reif-Leonhard@kgu.de.
authors.forename: C
authors.initials: C
authors.lastname: Reif-Leonhard
authors.affiliation: Center for Translational Research in Systems Neuroscience and Psychiatry, Clinic for Psychiatry and Psychotherapy, University Medical Center Göttingen, Göttingen, Germany. Oliver.Gruber@medizin.uni-goettingen.de.
authors.forename: O
authors.initials: O
authors.lastname: Gruber
authors.affiliation: Coordination Centre for Clinical, Trials (KKS) Dresden, Medical Faculty Carl Gustav Carus, TU Dresden, Dresden , Germany. Barbara.Djawid@uniklinikum-dresden.de.
authors.forename: B
authors.initials: B
authors.lastname: Djawid
authors.affiliation: Department of Epidemiology Dalla Lana School of Public Health, University of Toronto, Toronto, Canada. sarah.doucette@dal.ca.
authors.forename: S
authors.initials: S
authors.lastname: Goodday
authors.affiliation: Department of Psychiatry and Psychotherapy, University Hospital Carl Gustav Carus, Technische Universität Dresden, Fetscherstr. 74, Dresden, D-01307, Germany. robert.haussmann@uniklinikum-dresden.de.
authors.forename: R
authors.initials: R
authors.lastname: Haussmann
authors.affiliation: Department of Psychiatry and Psychotherapy, University Hospital Carl Gustav Carus, Technische Universität Dresden, Fetscherstr. 74, Dresden, D-01307, Germany. Andrea.Pfennig@uniklinikum-dresden.de.
authors.forename: A
authors.initials: A
authors.lastname: Pfennig
authors.affiliation: Department of Psychiatry and Psychotherapy, University Hospital Carl Gustav Carus, Technische Universität Dresden, Fetscherstr. 74, Dresden, D-01307, Germany. Philipp.Ritter@uniklinikum-dresden.de.
authors.forename: P
authors.initials: P
authors.lastname: Ritter
authors.affiliation: Department of Psychiatry and Psychotherapy, University Hospital Carl Gustav Carus, Technische Universität Dresden, Fetscherstr. 74, Dresden, D-01307, Germany. Joern.Conell@uniklinikum-dresden.de.
authors.forename: J
authors.initials: J
authors.lastname: Conell
authors.affiliation: Department of Psychiatry and Psychotherapy, University Hospital Carl Gustav Carus, Technische Universität Dresden, Fetscherstr. 74, Dresden, D-01307, Germany. Emanuel.Severus@uniklinikum-dresden.de.
authors.forename: E
authors.initials: E
authors.lastname: Severus
authors.affiliation: Department of Psychiatry and Psychotherapy, University Hospital Carl Gustav Carus, Technische Universität Dresden, Fetscherstr. 74, Dresden, D-01307, Germany. michael.bauer@uniklinikum-dresden.de.
authors.forename: M
authors.initials: M
authors.lastname: Bauer
mesh_terms: D000328:Adult; D002985:Clinical Protocols; D003865:Major Depressive Disorder / Q000188:drug therapy* / Q000523:psychology*; D005260:Female; D006801:Humans; D008094:Lithium / Q000494:pharmacology* / Q000627:therapeutic use*; D008297:Male; D008875:Middle Aged; D059020:Suicidal Ideation; D013405:Suicide / Q000523:psychology*; D016896:Treatment Outcome; D000092864:Suicide Prevention
chemical_list: D008094:Lithium