Suicide Prevention by Lithium - the Lithium Intervention Study

Suicide Clinical Trial

— SUPLI  

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00520026
• Other study ID #: FKZ 01 GI9920 / 01 GI0220
• Status: Terminated
• Phase: N/A
• First received: August 22, 2007
• Last updated: August 22, 2007
• Start date: January 2001
• Est. completion date: June 2006

Study information

• Verified date: August 2007
• Source: University of Schleswig-Holstein
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 167
• Est. completion date: June 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Depressive Disorders
• Suicide

Intervention

Drug:
• lithium

• placebo

Locations

Country	Name	City	State
Germany	Department of Psychiatry and Psychotherapy, Charité-Universitätsmedizin Berlin, Campus Benjamin Franklin	Berlin
Germany	Department of Psychiatry and Psychotherapy, Rheinische Friedrich-Willhelms-Universität	Bonn
Germany	Department of Psychiatry and Psychotherapy, Medizinische Fakultät der Technischen Universität Dresden	Dresden
Germany	Department of Psychiatry and Psychotherapy, Universitätsklinikum Schleswig-Holstein, Campus Luebeck	Luebeck
Germany	Department of Psychiatry and Psychotherapy, Klinikum Nuremberg Nord	Nuremberg

Sponsors (7)

Lead Sponsor	Collaborator
University of Schleswig-Holstein	Charite University, Berlin, Germany, German Federal Ministry of Education and Research, Sanofi, Technische Universität Dresden, University of Bonn, University of Erlangen-Nürnberg

Country where clinical trial is conducted

Germany, 

References & Publications (4)

Ahrens B, Müller-Oerlinghausen B. Does lithium exert an independent antisuicidal effect? Pharmacopsychiatry. 2001 Jul;34(4):132-6. — View Citation

Lauterbach E, Ahrens B, Felber W, Oerlinghausen BM, Kilb B, Bischof G, Heuser I, Werner P, Hawellek B, Maier W, Lewitzka U, Pogarell O, Hegerl U, Bronisch T, Richter K, Niklewski G, Broocks A, Hohagen F. Suicide prevention by lithium SUPLI--challenges of a multi-center prospective study. Arch Suicide Res. 2005;9(1):27-34. — View Citation

Müller-Oerlinghausen B, Berghöfer A, Ahrens B. The antisuicidal and mortality-reducing effect of lithium prophylaxis: consequences for guidelines in clinical psychiatry. Can J Psychiatry. 2003 Aug;48(7):433-9. Review. — View Citation

Müller-Oerlinghausen B, Felber W, Berghöfer A, Lauterbach E, Ahrens B. The impact of lithium long-term medication on suicidal behavior and mortality of bipolar patients. Arch Suicide Res. 2005;9(3):307-19. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	occurrence of attempted and completed suicides		follow-up period of 1 year
Secondary	Specific aspects of the suicide attempt/completed suicide		follow-up period of 1 year