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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/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. TRIAL REGISTRATION:ClinicalTrials.gov identifier: NCT02039479.

journal_name

BMC Psychiatry

journal_title

BMC psychiatry

authors

Lewitzka U,Jabs B,Fülle M,Holthoff V,Juckel G,Uhl I,Kittel-Schneider S,Reif A,Reif-Leonhard C,Gruber O,Djawid B,Goodday S,Haussmann R,Pfennig A,Ritter P,Conell J,Severus E,Bauer M

doi

10.1186/s12888-015-0499-5

subject

Has Abstract

pub_date

2015-05-19 00:00:00

pages

117

issn

1471-244X

pii

10.1186/s12888-015-0499-5

journal_volume

pub_type

杂志文章,多中心研究,随机对照试验

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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.