SuicideSUPLINCT00520026
Suicide Prevention by Lithium - the Lithium Intervention Study
A study testing lithium in people with Suicide and Depressive Disorders, run by University Hospital Schleswig-Holstein at 5 sites in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Suicide, Depressive Disorders
- What is being tested?
- lithium
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 167 participants
- Where
- 5 sitesGermany
- Study dates
- Jan 2001to Jun 2006
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- diagnosis of schizophrenia, borderline personality disorder, substance related disorders
- indication for long-term lithium treatment
- thyroid disease
- pregnancy and lactation
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
Germany5 sites
Department of Psychiatry and Psychotherapy, Charité-Universitätsmedizin Berlin, Campus Benjamin Franklin
Berlin, 14050
Department of Psychiatry and Psychotherapy, Rheinische Friedrich-Willhelms-Universität
Bonn, 53105
Department of Psychiatry and Psychotherapy, Medizinische Fakultät der Technischen Universität Dresden
Dresden, 01307
Department of Psychiatry and Psychotherapy, Universitätsklinikum Schleswig-Holstein, Campus Luebeck
Lübeck, 23538
Department of Psychiatry and Psychotherapy, Klinikum Nuremberg Nord
Nuremberg, 90419
About this study
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.
Read the 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.
- Conditions
- Suicide, Depressive Disorders
- Being tested
- lithium, placebo
- Keywords
- suicide, prevention, lithium, suicidality
- Medical subject headings
- Suicide, Depressive Disorder, Suicidal Ideation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
lithiumDrug
placeboDrug
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Lithium treatment Receives: Drug: lithium |
| 2 | Placebo comparator | Placebo treatment Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
occurrence of attempted and completed suicides
Measured: follow-up period of 1 year
Secondary outcomes (1)
Specific aspects of the suicide attempt/completed suicide
Measured: follow-up period of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Aug 2007 (estimated)
- Study startJan 2001
- Study completionJun 2006
Why it stopped: number of enrolled individuals after 5 years still off the estimated sample size
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for SuicideStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 167 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital Schleswig-Holstein
- Sponsor type
- University, hospital or other
- Collaborators
- German Federal Ministry of Education and Research, Sanofi, Technische Universität Dresden, University of Bonn, Charite University, Berlin, Germany, University of Erlangen-Nürnberg
- Investigators
- Fritz Hohagen, Prof., Study director, Department of Psychiatry and Psychotherapy, Universitätsklinikum Schleswig-Holstein, Campus LuebeckBruno Müller-Oerlinghausen, Prof., Study chair, Former Research Group Clinical Psychopharmacology, Department of Psychiatry and Psychotherapy, Charité-Universitätsmedizin Berlin, Campus Benjamin FranklinWerner Felber, Prof., Study chair, Department of Psychiatry and Psychotherapy, Medizinische Fakultät der Technischen Universität DresdenBernd Ahrens, PD, Study chair, Department of Psychiatry and Psychotherapy, Universitätsklinikum Schleswig-Holstein, Campus LuebeckErik Lauterbach, Dr., Principal investigator, Department of Psychiatry and Psychotherapy, Universitätsklinikum Schleswig-Holstein, Campus LuebeckThomas Bronisch, Prof., Study chair, Max-Planck-Institute of Psychiatry Munich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00520026
- Sponsor's protocol ID
- FKZ 01 GI9920 / 01 GI0220
- Acronym
- SUPLI
- Status last verified
- Aug 2007
- First submitted
- 22 Aug 2007
- Last updated
- 23 Aug 2007
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 16040577Muller-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.
PubMed 16020173Muller-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.
PubMed 12971012Ahrens B, Muller-Oerlinghausen B. Does lithium exert an independent antisuicidal effect? Pharmacopsychiatry. 2001 Jul;34(4):132-6. doi: 10.1055/s-2001-15878.
PubMed 11518473