Suicide Prevention by Lithium - the Lithium Intervention Study (SUPLI)
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| First Received Date ICMJE | August 22, 2007 | ||||||||||||||||||||||||
| Last Updated Date | August 22, 2007 | ||||||||||||||||||||||||
| Start Date ICMJE | January 2001 | ||||||||||||||||||||||||
| Primary Completion Date | Not Provided | ||||||||||||||||||||||||
| Current Primary Outcome Measures ICMJE |
occurrence of attempted and completed suicides [ Time Frame: follow-up period of 1 year ] | ||||||||||||||||||||||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||||||||||||||||||||||
| Change History | No Changes Posted | ||||||||||||||||||||||||
| Current Secondary Outcome Measures ICMJE |
Specific aspects of the suicide attempt/completed suicide [ Time Frame: follow-up period of 1 year ] | ||||||||||||||||||||||||
| Original Secondary Outcome Measures ICMJE | Same as current | ||||||||||||||||||||||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||||||||||||||||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||||||||||||||||||
| Descriptive Information | |||||||||||||||||||||||||
| Brief Title ICMJE | Suicide Prevention by Lithium - the Lithium Intervention Study | ||||||||||||||||||||||||
| Official Title ICMJE | Not Provided | ||||||||||||||||||||||||
| 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. |
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| 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. |
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| Study Type ICMJE | Interventional | ||||||||||||||||||||||||
| Study Phase | Not Provided | ||||||||||||||||||||||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator) Primary Purpose: Prevention |
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| Condition ICMJE |
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| Intervention ICMJE |
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| Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||||||||||||||||||
| Recruitment Status ICMJE | Terminated | ||||||||||||||||||||||||
| Enrollment ICMJE | 167 | ||||||||||||||||||||||||
| Completion Date | June 2006 | ||||||||||||||||||||||||
| Primary Completion Date | Not Provided | ||||||||||||||||||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||||||||||||||||||||||
| Ages | 18 Years and older | ||||||||||||||||||||||||
| Accepts Healthy Volunteers | No | ||||||||||||||||||||||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||||||||||||||||||||
| Location Countries ICMJE | Germany | ||||||||||||||||||||||||
| Administrative Information | |||||||||||||||||||||||||
| NCT Number ICMJE | NCT00520026 | ||||||||||||||||||||||||
| Other Study ID Numbers ICMJE | FKZ 01 GI9920 / 01 GI0220 | ||||||||||||||||||||||||
| Has Data Monitoring Committee | No | ||||||||||||||||||||||||
| Responsible Party | Not Provided | ||||||||||||||||||||||||
| Study Sponsor ICMJE | University of Schleswig-Holstein | ||||||||||||||||||||||||
| Collaborators ICMJE |
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| Investigators ICMJE |
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| Information Provided By | University of Schleswig-Holstein | ||||||||||||||||||||||||
| Verification Date | August 2007 | ||||||||||||||||||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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