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

This study has been terminated.
(number of enrolled individuals after 5 years still off the estimated sample size)
Sponsor:
Collaborators:
German Federal Ministry of Education and Research
Sanofi
Technische Universität Dresden
University of Bonn
Charite University, Berlin, Germany
University of Erlangen-Nürnberg
Information provided by:
University of Schleswig-Holstein
ClinicalTrials.gov Identifier:
NCT00520026
First received: August 22, 2007
Last updated: NA
Last verified: August 2007
History: No changes posted
  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

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

Resource links provided by NLM:


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
Active Comparator: 1
Lithium treatment
Drug: lithium
Placebo Comparator: 2
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
Germany
Department of Psychiatry and Psychotherapy, Charité-Universitätsmedizin Berlin, Campus Benjamin Franklin
Berlin, Germany, 14050
Department of Psychiatry and Psychotherapy, Rheinische Friedrich-Willhelms-Universität
Bonn, Germany, 53105
Department of Psychiatry and Psychotherapy, Medizinische Fakultät der Technischen Universität Dresden
Dresden, Germany, 01307
Department of Psychiatry and Psychotherapy, Universitätsklinikum Schleswig-Holstein, Campus Luebeck
Luebeck, Germany, 23538
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
Technische Universität Dresden
University of 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:
ClinicalTrials.gov Identifier: NCT00520026     History of Changes
Other Study ID Numbers: FKZ 01 GI9920 / 01 GI0220
Study First Received: August 22, 2007
Last Updated: August 22, 2007
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by University of Schleswig-Holstein:
suicide
prevention
lithium
suicidality

Additional relevant MeSH terms:
Depressive Disorder
Depression
Suicide
Mood Disorders
Mental Disorders
Behavioral Symptoms
Self-Injurious Behavior
Lithium
Lithium Carbonate
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Psychotropic Drugs
Antimanic Agents
Antidepressive Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on September 18, 2014