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Suicide Prevention by Lithium - the Lithium Intervention Study

Status
Terminated
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00520026
Acronym
SUPLI
Enrollment
167
Registered
2007-08-23
Start date
2001-01-31
Completion date
2006-06-30
Last updated
2007-08-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Depressive Disorders, Suicide

Keywords

suicide, prevention, lithium, suicidality

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.

Interventions

DRUGlithium
DRUGplacebo

Sponsors

German Federal Ministry of Education and Research
CollaboratorOTHER_GOV
Sanofi
CollaboratorINDUSTRY
Technische Universität Dresden
CollaboratorOTHER
University of Bonn
CollaboratorOTHER
Charite University, Berlin, Germany
CollaboratorOTHER
University of Erlangen-Nürnberg
CollaboratorOTHER
University Hospital Schleswig-Holstein
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
occurrence of attempted and completed suicidesfollow-up period of 1 year

Secondary

MeasureTime frame
Specific aspects of the suicide attempt/completed suicidefollow-up period of 1 year

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026