Clinical trial NCT00520026: Suicide Prevention by Lithium - the Lithium Intervention Study
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Suicide
Depressive Disorders
Keywords: suicide
prevention
lithium
suicidality
Lead sponsor: University Hospital Schleswig-Holstein
Sponsor class: OTHER
Collaborators: name: German Federal Ministry of Education and Research
name: Sanofi
name: Technische Universität Dresden
name: University of Bonn
name: Charite University, Berlin, Germany
name: University of Erlangen-Nürnberg
First posted: 2007-08-23
Enrollment: 167
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility 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

Primary outcomes:
measure: occurrence of attempted and completed suicides
timeFrame: follow-up period of 1 year
Secondary outcomes:
measure: Specific aspects of the suicide attempt/completed suicide
timeFrame: follow-up period of 1 year
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Department of Psychiatry and Psychotherapy, Charité-Universitätsmedizin Berlin, Campus Benjamin Franklin
city: Bonn
country: Germany
facility: Department of Psychiatry and Psychotherapy, Rheinische Friedrich-Willhelms-Universität
city: Dresden
country: Germany
facility: Department of Psychiatry and Psychotherapy, Medizinische Fakultät der Technischen Universität Dresden
city: Luebeck
country: Germany
facility: Department of Psychiatry and Psychotherapy, Universitätsklinikum Schleswig-Holstein, Campus Luebeck
city: Nuremberg
country: Germany
facility: Department of Psychiatry and Psychotherapy, Klinikum Nuremberg Nord
Study officials:
affiliation: Department of Psychiatry and Psychotherapy, Universitätsklinikum Schleswig-Holstein, Campus Luebeck
name: Fritz Hohagen, Prof.
role: STUDY_DIRECTOR
affiliation: Former Research Group Clinical Psychopharmacology, Department of Psychiatry and Psychotherapy, Charité-Universitätsmedizin Berlin, Campus Benjamin Franklin
name: Bruno Müller-Oerlinghausen, Prof.
role: STUDY_CHAIR
affiliation: Department of Psychiatry and Psychotherapy, Medizinische Fakultät der Technischen Universität Dresden
name: Werner Felber, Prof.
role: STUDY_CHAIR
affiliation: Department of Psychiatry and Psychotherapy, Universitätsklinikum Schleswig-Holstein, Campus Luebeck
name: Bernd Ahrens, PD
role: STUDY_CHAIR
affiliation: Department of Psychiatry and Psychotherapy, Universitätsklinikum Schleswig-Holstein, Campus Luebeck
name: Erik Lauterbach, Dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: Max-Planck-Institute of Psychiatry Munich
name: Thomas Bronisch, Prof.
role: STUDY_CHAIR
References:
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. doi: 10.1080/13811110590512886.
citation: Muller-Oerlinghausen B, Felber W, Berghofer 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. doi: 10.1080/13811110590929550.
citation: Muller-Oerlinghausen B, Berghofer 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. doi: 10.1177/070674370304800702.
citation: Ahrens B, Muller-Oerlinghausen B. Does lithium exert an independent antisuicidal effect? Pharmacopsychiatry. 2001 Jul;34(4):132-6. doi: 10.1055/s-2001-15878.