Last updated on March 2018

Randomized Placebo-controlled Multicenter Trial of Lithium Plus Treatment as Usual (TAU) for Acute Suicidal Ideation and Behavior in Patients With Suicidal Major Depressive Episode

Brief description of study

The primary hypothesis of this confirmatory study is that lithium therapy will acutely decrease suicidal ideation and/or suicidal behaviour 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 behaviour over 5 weeks in inpatients with MDE.

Detailed Study Description

The study will consist of 254 adult patients, hospitalized for a major depressive episode with suicidal ideation and/or behaviour who will be randomized to two groups of each 127 participants. All study participants will receive treatment as usual in the hospital, including (psycho)pharmacological treatment and, if needed, psychotherapy plus a 5-week course of lithium or placebo. Rating scales will be used daily resp. weekly to measure suicidal ideation and/or behaviour, depression, anxiety, mixed/manic features and impulsiveness. Experienced clinicians will rate suicidal ideation and/or behaviour as well as depression twice a week and anxiety, mixed/manic features and impulsiveness once a week.

Clinical Study Identifier: NCT02039479

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