Suicide Prevention by Lithium - the Lithium Intervention Study - Full Text View

Suicide Prevention by Lithium - the Lithium Intervention Study (SUPLI)

This study has been terminated.

Sponsors and Collaborators:	University of Schleswig-Holstein German Federal Ministry of Education and Research Sanofi-Aventis Dresden University of Technology University Hospital, Bonn Charite University, Berlin, Germany University of Erlangen-Nürnberg
Information provided by:	University of Schleswig-Holstein
ClinicalTrials.gov Identifier:	NCT00520026

Purpose

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.

Condition	Intervention
Suicide Depressive Disorders	Drug: lithium Drug: placebo

MedlinePlus related topics: Depression Suicide

Drug Information available for: Lithium carbonate Lithium citrate

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Double Blind (Subject, Caregiver, Investigator), Placebo Control, Parallel Assignment, Efficacy Study

Further study details as provided by University of Schleswig-Holstein:

Primary Outcome Measures:

occurrence of attempted and completed suicides [ Time Frame: follow-up period of 1 year ]

Secondary Outcome Measures:

Specific aspects of the suicide attempt/completed suicide [ Time Frame: follow-up period of 1 year ]

Enrollment:	167
Study Start Date:	January 2001
Study Completion Date:	June 2006

Arms	Assigned Interventions
1: Active Comparator Lithium treatment	Drug: lithium
2: Placebo Comparator Placebo treatment	Drug: placebo

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

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00520026

Locations

Germany
Department of Psychiatry and Psychotherapy, Universitätsklinikum Schleswig-Holstein, Campus Luebeck
Luebeck, Germany, 23538
Department of Psychiatry and Psychotherapy, Medizinische Fakultät der Technischen Universität Dresden
Dresden, Germany, 01307
Department of Psychiatry and Psychotherapy, Rheinische Friedrich-Willhelms-Universität
Bonn, Germany, 53105
Department of Psychiatry and Psychotherapy, Charité-Universitätsmedizin Berlin, Campus Benjamin Franklin
Berlin, Germany, 14050
Department of Psychiatry and Psychotherapy, Klinikum Nuremberg Nord
Nuremberg, Germany, 90419

Sponsors and Collaborators

University of Schleswig-Holstein

German Federal Ministry of Education and Research

Sanofi-Aventis

Dresden University of Technology

University Hospital, Bonn

Charite University, Berlin, Germany

University of Erlangen-Nürnberg

Investigators

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

More Information

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.

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. Review.

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. Review.

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

Study ID Numbers:	FKZ 01 GI9920 / 01 GI0220
Study First Received:	August 22, 2007
Last Updated:	August 22, 2007
ClinicalTrials.gov Identifier:	NCT00520026
Health Authority:	Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by University of Schleswig-Holstein:

suicide
prevention
lithium
suicidality

Study placed in the following topic categories:

Depression
Mental Disorders
Mood Disorders
Lithium Carbonate
Suicide

Depressive Disorder
Lithium
Self-Injurious Behavior
Behavioral Symptoms

Additional relevant MeSH terms:

Tranquilizing Agents
Molecular Mechanisms of Pharmacological Action
Therapeutic Uses
Physiological Effects of Drugs
Psychotropic Drugs
Central Nervous System Depressants

Enzyme Inhibitors
Antimanic Agents
Antipsychotic Agents
Central Nervous System Agents
Antidepressive Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009