NCT02039479

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 254 (estimated)
• Sponsor: Technische Universität Dresden · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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 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.

Conditions

• Suicidal Ideation/Behavior
• Depression

Interventions

Type	Name	Description
DRUG	Lithium Carbonate	Lithium as Add on to every necessary treatment as usual
DRUG	Placebo	Placebo as ADD-on to every necessary treatment as usual

Timeline

• Start date: 2014-01-01
• Primary completion: 2018-03-01
• Completion: 2018-06-01
• First posted: 2014-01-17
• Last updated: 2018-03-15

Locations

5 sites across 1 country: Germany