TY - JOUR A1 - Lewitzka, Ute A1 - Jabs, Burkhard A1 - Fülle, Matthias A1 - Holthoff, Vjera A1 - Juckel, Georg A1 - Uhl, Idun A1 - Kittel-Schneider, Sarah A1 - Reif, Andreas A1 - Reif-Leonhard, Christine A1 - Gruber, Oliver A1 - Djawid, B. A1 - Goodday, S. A1 - Haussmann, Robert A1 - Pfennig, Andrea A1 - Ritter, Philipp A1 - Conell, Jörn A1 - Severus, Emanuel A1 - Bauer, Michael T1 - 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 T2 - BMC psychiatry N2 - 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/Design: 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. Discussion: 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. KW - Randomized controlled trial KW - Lithium KW - Suicidal thoughts KW - Suicidal behavior KW - Affective disorders Y1 - 2015 UR - http://publikationen.ub.uni-frankfurt.de/frontdoor/index/index/docId/38013 UR - https://nbn-resolving.org/urn:nbn:de:hebis:30:3-380130 SN - 1471-244X N1 - © 2015 Lewitzka et al. This is an Open Access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/4.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly credited. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated. VL - 15 IS - 117 SP - 1 EP - 7 PB - BioMed Central CY - London ER -