number of enrolled individuals after 5 years still off the estimated sample size

The purpose of this study is to examine the proposed suicide preventive effects of lithium in a randomized controlled trial within a group of individuals with depressive disorders. The hypothesis being tested is that lithium treatment will significantly reduce the risk for another suicide attempt.

Several studies have shown that there is a significantly increased risk of suicide related mortality in patients with a positive history of suicide attempts. This study is the first prospective, randomized, double-blind, placebo controlled multi-center trial focussing on the proposed suicide preventive effects of lithium in patients with suicidal behavior but not suffering from bipolar disorder or recurrent major depressive disorder. Patients with a recent history of a suicide attempt are treated with lithium or placebo during a 12 month-period. The hypothesis is that lithium treatment will lead to a 50 % reduction of suicidal behavior.

Inclusion Criteria:

• suicide attempt within 3 months prior to the first drug administration
• occurrence of suicide attempt within the context of an affective spectrum disorder
• minimum age of 18 years
• ability to complete screening and baseline assessment
• ability to understand and provide informed consent

Exclusion Criteria:

• diagnosis of schizophrenia, borderline personality disorder, substance related disorders
• indication for long-term lithium treatment
• thyroid disease
• pregnancy and lactation