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Suicide Prevention by Lithium - the Lithium Intervention Study

NCT ID: NCT00520026

Last Updated: 2007-08-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

167 participants

Study Classification

INTERVENTIONAL

Study Start Date

2001-01-31

Study Completion Date

2006-06-30

Brief Summary

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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

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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.

Conditions

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Suicide Depressive Disorders

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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1

Lithium treatment

Group Type ACTIVE_COMPARATOR

lithium

Intervention Type DRUG

2

Placebo treatment

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type DRUG

Interventions

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lithium

Intervention Type DRUG

placebo

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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German Federal Ministry of Education and Research

OTHER_GOV

Sponsor Role collaborator

Sanofi

INDUSTRY

Sponsor Role collaborator

Technische Universität Dresden

OTHER

Sponsor Role collaborator

University of Bonn

OTHER

Sponsor Role collaborator

Charite University, Berlin, Germany

OTHER

Sponsor Role collaborator

University of Erlangen-Nürnberg

OTHER

Sponsor Role collaborator

University Hospital Schleswig-Holstein

OTHER

Sponsor Role lead

Principal Investigators

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Fritz Hohagen, Prof.

Role: STUDY_DIRECTOR

Department of Psychiatry and Psychotherapy, Universitätsklinikum Schleswig-Holstein, Campus Luebeck

Bruno Müller-Oerlinghausen, Prof.

Role: STUDY_CHAIR

Former Research Group Clinical Psychopharmacology, Department of Psychiatry and Psychotherapy, Charité-Universitätsmedizin Berlin, Campus Benjamin Franklin

Werner Felber, Prof.

Role: STUDY_CHAIR

Department of Psychiatry and Psychotherapy, Medizinische Fakultät der Technischen Universität Dresden

Bernd Ahrens, PD

Role: STUDY_CHAIR

Department of Psychiatry and Psychotherapy, Universitätsklinikum Schleswig-Holstein, Campus Luebeck

Erik Lauterbach, Dr.

Role: PRINCIPAL_INVESTIGATOR

Department of Psychiatry and Psychotherapy, Universitätsklinikum Schleswig-Holstein, Campus Luebeck

Thomas Bronisch, Prof.

Role: STUDY_CHAIR

Max-Planck-Institute of Psychiatry Munich

Locations

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Department of Psychiatry and Psychotherapy, Charité-Universitätsmedizin Berlin, Campus Benjamin Franklin

Berlin, , Germany

Site Status

Department of Psychiatry and Psychotherapy, Rheinische Friedrich-Willhelms-Universität

Bonn, , Germany

Site Status

Department of Psychiatry and Psychotherapy, Medizinische Fakultät der Technischen Universität Dresden

Dresden, , Germany

Site Status

Department of Psychiatry and Psychotherapy, Universitätsklinikum Schleswig-Holstein, Campus Luebeck

Lübeck, , Germany

Site Status

Department of Psychiatry and Psychotherapy, Klinikum Nuremberg Nord

Nuremberg, , Germany

Site Status

Countries

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Germany

References

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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.

Reference Type BACKGROUND
PMID: 16040577 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 16020173 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 12971012 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 11518473 (View on PubMed)

Other Identifiers

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FKZ 01 GI9920 / 01 GI0220

Identifier Type: -

Identifier Source: org_study_id