Suicide Prevention by Lithium - the Lithium Intervention Study
Trial Snapshot
- Phase
- Not Applicable
- Status
- Terminated
- Sponsor
- Enrollment
- 167
- Locations
- 5
- Primary Endpoint
- occurrence of attempted and completed suicides
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Triple (Participant, Care Provider, Investigator)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts 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
Arms & Interventions
1
Lithium treatment
Intervention: lithium (Drug)
2
Placebo treatment
Intervention: placebo (Drug)
Outcomes
Primary Outcomes
occurrence of attempted and completed suicides
Time Frame: follow-up period of 1 year
Secondary Outcomes
- Specific aspects of the suicide attempt/completed suicide(follow-up period of 1 year)