Suicide Prevention by Lithium - the Lithium Intervention Study

Not Applicable

Terminated

• Conditions: Suicide; Depressive Disorders
• Interventions: Drug: placebo; Drug: lithium

• Registration Number: NCT00520026
• Lead Sponsor: University Hospital Schleswig-Holstein

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study Start: 2001-01
• Study Completion: 2006-06
• Status Verified: 2007-08
• Study First Submitted: 2007-08-22
• Study First Submitted QC: 2007-08-22
• Last Update Submitted: 2007-08-22
• Study First Posted: 2007-08-23
• Last Update Posted: 2007-08-23

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 167

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2	placebo	Placebo treatment
1	lithium	Lithium treatment

Primary Outcome Measures

Name	Time	Method
occurrence of attempted and completed suicides	follow-up period of 1 year

Secondary Outcome Measures

Name	Time	Method
Specific aspects of the suicide attempt/completed suicide	follow-up period of 1 year

Trial Locations

Locations (5)

Department of Psychiatry and Psychotherapy, Universitätsklinikum Schleswig-Holstein, Campus Luebeck; 🇩🇪 Luebeck, Germany

Department of Psychiatry and Psychotherapy, Rheinische Friedrich-Willhelms-Universität; 🇩🇪 Bonn, Germany

Department of Psychiatry and Psychotherapy, Charité-Universitätsmedizin Berlin, Campus Benjamin Franklin; 🇩🇪 Berlin, Germany

Department of Psychiatry and Psychotherapy, Klinikum Nuremberg Nord; 🇩🇪 Nuremberg, Germany

Department of Psychiatry and Psychotherapy, Medizinische Fakultät der Technischen Universität Dresden; 🇩🇪 Dresden, Germany