NCT00520026

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
167

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2001

Longer than P75 for not_applicable

Geographic Reach
1 country

5 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2001

Completed
5.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2006

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

August 22, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 23, 2007

Completed
Last Updated

August 23, 2007

Status Verified

August 1, 2007

First QC Date

August 22, 2007

Last Update Submit

August 22, 2007

Conditions

SuicideDepressive Disorders

Keywords

suicidepreventionlithiumsuicidality

Outcome Measures

Primary Outcomes (1)

  • occurrence of attempted and completed suicides

    follow-up period of 1 year

Secondary Outcomes (1)

  • Specific aspects of the suicide attempt/completed suicide

    follow-up period of 1 year

Study Arms (2)

1

ACTIVE COMPARATOR

Lithium treatment

Drug: lithium

2

PLACEBO COMPARATOR

Placebo treatment

Drug: placebo

Interventions

lithiumDRUG
1
placeboDRUG
2

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • diagnosis of schizophrenia, borderline personality disorder, substance related disorders
  • indication for long-term lithium treatment
  • thyroid disease
  • pregnancy and lactation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

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

Berlin, 14050, Germany

Location

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

Bonn, 53105, Germany

Location

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

Dresden, 01307, Germany

Location

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

Lübeck, 23538, Germany

Location

Department of Psychiatry and Psychotherapy, Klinikum Nuremberg Nord

Nuremberg, 90419, Germany

Location

Related Publications (4)

  • 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.

    PMID: 16040577BACKGROUND

  • 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.

    PMID: 16020173BACKGROUND

  • 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.

    PMID: 12971012BACKGROUND

  • 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.

    PMID: 11518473BACKGROUND

MeSH Terms

Conditions

SuicideDepressive DisorderSuicidal Ideation

Interventions

Lithium

Condition Hierarchy (Ancestors)

Self-Injurious BehaviorBehavioral SymptomsBehaviorMood DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Metals, AlkaliElementsInorganic ChemicalsMetals, LightMetals

Study Officials

  • Fritz Hohagen, Prof.

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

    STUDY DIRECTOR

  • 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

    STUDY CHAIR

  • Erik Lauterbach, Dr.

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

    PRINCIPAL INVESTIGATOR

  • Thomas Bronisch, Prof.

    Max-Planck-Institute of Psychiatry Munich

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

August 22, 2007

First Posted

August 23, 2007

Study Start

January 1, 2001

Study Completion

June 1, 2006

Last Updated

August 23, 2007

Record last verified: 2007-08

Locations

DE(5)