SUPLI: Suicide Prevention by Lithium - the Lithium Intervention Study

Sponsor

University Hospital Schleswig-Holstein (Other)

Overall Status

Terminated

CT.gov ID

NCT00520026

Collaborator

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

167

Enrollment

Locations

Arms

Duration (Months)

33.4

Patients Per Site

0.5

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Suicide Depressive Disorders	Drug: lithium Drug: placebo	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

167 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Care Provider, Investigator)

Primary Purpose:

Prevention

Study Start Date :

Jan 1, 2001

Actual Study Completion Date :

Jun 1, 2006

Arms and Interventions

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

Arm

Intervention/Treatment

Active Comparator: 1

Lithium treatment

Drug: lithium

Placebo Comparator: 2

Placebo treatment

Drug: placebo

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	Country	Postal Code
1	Department of Psychiatry and Psychotherapy, Charité-Universitätsmedizin Berlin, Campus Benjamin Franklin	Berlin	Germany	14050
2	Department of Psychiatry and Psychotherapy, Rheinische Friedrich-Willhelms-Universität	Bonn	Germany	53105
3	Department of Psychiatry and Psychotherapy, Medizinische Fakultät der Technischen Universität Dresden	Dresden	Germany	01307
4	Department of Psychiatry and Psychotherapy, Universitätsklinikum Schleswig-Holstein, Campus Luebeck	Luebeck	Germany	23538
5	Department of Psychiatry and Psychotherapy, Klinikum Nuremberg Nord	Nuremberg	Germany	90419

Sponsors and Collaborators

University Hospital 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