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

Primary Purpose

Suicide, Depressive Disorders

Status
Terminated
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
lithium
placebo
Sponsored by
University Hospital Schleswig-Holstein
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Suicide focused on measuring suicide, prevention, lithium, suicidality

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

1

2

Arm Description

Lithium treatment

Placebo treatment

Outcomes

Primary Outcome Measures

occurrence of attempted and completed suicides

Secondary Outcome Measures

Specific aspects of the suicide attempt/completed suicide

Full Information

First Posted
August 22, 2007
Last Updated
August 22, 2007
Sponsor
University Hospital Schleswig-Holstein
Collaborators
German Federal Ministry of Education and Research, Sanofi, Technische Universität Dresden, University of Bonn, Charite University, Berlin, Germany, University of Erlangen-Nürnberg
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1. Study Identification

Unique Protocol Identification Number
NCT00520026
Brief Title
Suicide Prevention by Lithium - the Lithium Intervention Study
Acronym
SUPLI
Study Type
Interventional

2. Study Status

Record Verification Date
August 2007
Overall Recruitment Status
Terminated
Why Stopped
number of enrolled individuals after 5 years still off the estimated sample size
Study Start Date
January 2001 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
June 2006 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
University Hospital Schleswig-Holstein
Collaborators
German Federal Ministry of Education and Research, Sanofi, Technische Universität Dresden, University of Bonn, Charite University, Berlin, Germany, University of Erlangen-Nürnberg

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Suicide, Depressive Disorders
Keywords
suicide, prevention, lithium, suicidality

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
167 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Active Comparator
Arm Description
Lithium treatment
Arm Title
2
Arm Type
Placebo Comparator
Arm Description
Placebo treatment
Intervention Type
Drug
Intervention Name(s)
lithium
Intervention Type
Drug
Intervention Name(s)
placebo
Primary Outcome Measure Information:
Title
occurrence of attempted and completed suicides
Time Frame
follow-up period of 1 year
Secondary Outcome Measure Information:
Title
Specific aspects of the suicide attempt/completed suicide
Time Frame
follow-up period of 1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Fritz Hohagen, Prof.
Organizational Affiliation
Department of Psychiatry and Psychotherapy, Universitätsklinikum Schleswig-Holstein, Campus Luebeck
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Bruno Müller-Oerlinghausen, Prof.
Organizational Affiliation
Former Research Group Clinical Psychopharmacology, Department of Psychiatry and Psychotherapy, Charité-Universitätsmedizin Berlin, Campus Benjamin Franklin
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Werner Felber, Prof.
Organizational Affiliation
Department of Psychiatry and Psychotherapy, Medizinische Fakultät der Technischen Universität Dresden
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Bernd Ahrens, PD
Organizational Affiliation
Department of Psychiatry and Psychotherapy, Universitätsklinikum Schleswig-Holstein, Campus Luebeck
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Erik Lauterbach, Dr.
Organizational Affiliation
Department of Psychiatry and Psychotherapy, Universitätsklinikum Schleswig-Holstein, Campus Luebeck
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Thomas Bronisch, Prof.
Organizational Affiliation
Max-Planck-Institute of Psychiatry Munich
Official's Role
Study Chair
Facility Information:
Facility Name
Department of Psychiatry and Psychotherapy, Charité-Universitätsmedizin Berlin, Campus Benjamin Franklin
City
Berlin
ZIP/Postal Code
14050
Country
Germany
Facility Name
Department of Psychiatry and Psychotherapy, Rheinische Friedrich-Willhelms-Universität
City
Bonn
ZIP/Postal Code
53105
Country
Germany
Facility Name
Department of Psychiatry and Psychotherapy, Medizinische Fakultät der Technischen Universität Dresden
City
Dresden
ZIP/Postal Code
01307
Country
Germany
Facility Name
Department of Psychiatry and Psychotherapy, Universitätsklinikum Schleswig-Holstein, Campus Luebeck
City
Luebeck
ZIP/Postal Code
23538
Country
Germany
Facility Name
Department of Psychiatry and Psychotherapy, Klinikum Nuremberg Nord
City
Nuremberg
ZIP/Postal Code
90419
Country
Germany

12. IPD Sharing Statement

Citations:
PubMed Identifier
16040577
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.
Results Reference
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PubMed Identifier
16020173
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.
Results Reference
background
PubMed Identifier
12971012
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.
Results Reference
background
PubMed Identifier
11518473
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.
Results Reference
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Suicide Prevention by Lithium - the Lithium Intervention Study

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