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
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
First received: August 22, 2007
Last updated: NA
Last verified: August 2007
History: No changes posted

August 22, 2007
August 22, 2007
January 2001
Not Provided
occurrence of attempted and completed suicides [ Time Frame: follow-up period of 1 year ]
Same as current
No Changes Posted
Specific aspects of the suicide attempt/completed suicide [ Time Frame: follow-up period of 1 year ]
Same as current
Not Provided
Not Provided
 
Suicide Prevention by Lithium - the Lithium Intervention Study
Not Provided

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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Prevention
  • Suicide
  • Depressive Disorders
  • Drug: lithium
  • Drug: placebo
  • Active Comparator: 1
    Lithium treatment
    Intervention: Drug: lithium
  • Placebo Comparator: 2
    Placebo treatment
    Intervention: Drug: placebo

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
167
June 2006
Not Provided

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
NCT00520026
FKZ 01 GI9920 / 01 GI0220
No
Not Provided
University of Schleswig-Holstein
  • German Federal Ministry of Education and Research
  • Sanofi
  • Dresden University of Technology
  • University Hospital, Bonn
  • Charite University, Berlin, Germany
  • University of Erlangen-Nürnberg
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
University of Schleswig-Holstein
August 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP