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Suicide Prevention by Lithium - the Lithium Intervention Study

Information source: University of Schleswig-Holstein
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Suicide; Depressive Disorders

Intervention: lithium (Drug); placebo (Drug)

Phase: N/A

Status: Terminated

Sponsored by: University of Schleswig-Holstein

Official(s) and/or principal investigator(s):
Fritz Hohagen, Prof., Study Director, Affiliation: Department of Psychiatry and Psychotherapy, Universitätsklinikum Schleswig-Holstein, Campus Luebeck
Bruno Müller-Oerlinghausen, Prof., Study Chair, Affiliation: Former Research Group Clinical Psychopharmacology, Department of Psychiatry and Psychotherapy, Charité-Universitätsmedizin Berlin, Campus Benjamin Franklin
Werner Felber, Prof., Study Chair, Affiliation: Department of Psychiatry and Psychotherapy, Medizinische Fakultät der Technischen Universität Dresden
Bernd Ahrens, PD, Study Chair, Affiliation: Department of Psychiatry and Psychotherapy, Universitätsklinikum Schleswig-Holstein, Campus Luebeck
Erik Lauterbach, Dr., Principal Investigator, Affiliation: Department of Psychiatry and Psychotherapy, Universitätsklinikum Schleswig-Holstein, Campus Luebeck
Thomas Bronisch, Prof., Study Chair, Affiliation: Max-Planck-Institute of Psychiatry Munich

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.

Clinical Details

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

Primary outcome: occurrence of attempted and completed suicides

Secondary outcome: Specific aspects of the suicide attempt/completed suicide

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.

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

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

Locations and Contacts

Department of Psychiatry and Psychotherapy, Charité-Universitätsmedizin Berlin, Campus Benjamin Franklin, Berlin 14050, Germany

Department of Psychiatry and Psychotherapy, Rheinische Friedrich-Willhelms-Universität, Bonn 53105, Germany

Department of Psychiatry and Psychotherapy, Medizinische Fakultät der Technischen Universität Dresden, Dresden 01307, Germany

Department of Psychiatry and Psychotherapy, Universitätsklinikum Schleswig-Holstein, Campus Luebeck, Luebeck 23538, Germany

Department of Psychiatry and Psychotherapy, Klinikum Nuremberg Nord, Nuremberg 90419, Germany

Additional Information

Related publications:

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.

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.

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.

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

Starting date: January 2001
Last updated: August 22, 2007

Page last updated: August 23, 2015

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