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

August 22, 2007 updated by: University Hospital Schleswig-Holstein
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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

167

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 1
Lithium treatment
Drug: lithium
Placebo Comparator: 2
Placebo treatment
Drug: placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
occurrence of attempted and completed suicides
Time Frame: follow-up period of 1 year
follow-up period of 1 year

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital Schleswig-Holstein

Collaborators

Sanofi
Charite University, Berlin, Germany
German Federal Ministry of Education and Research
University of Erlangen-Nürnberg
Technische Universität Dresden
University of Bonn

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2001

Study Completion (Actual)

June 1, 2006

Study Registration Dates

First Submitted

August 22, 2007

First Submitted That Met QC Criteria

August 22, 2007

First Posted (Estimate)

August 23, 2007

Study Record Updates

Last Update Posted (Estimate)

August 23, 2007

Last Update Submitted That Met QC Criteria

August 22, 2007

Last Verified

August 1, 2007

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FKZ 01 GI9920 / 01 GI0220

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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