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NCT01928446 · ClinicalTrials.gov registry record · Phase 2
Lithium for Suicidal Behavior in Mood Disorders
A Phase 2 study, sponsored by VA Office of Research and Development.
- Terminated
- Registry status
- Phase 2
- Development phase
- 519
- Enrollment target
NCT01928446: Clinical Trial Phase 2 study, sponsored by VA Office of Research and Development.
NCT01928446 is a Phase 2 study that was terminated before completion, run by VA Office of Research and Development. The registered enrollment target is 519 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01928446, a Phase 2 study, was terminated before completion, sponsored by VA Office of Research and Development.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 519 participants
- Enrollment target
Study Summary
Observational evidence and findings from clinical trials conducted for other reasons suggest that lithium, a drug used for the treatment of bipolar disorder, and, to a lesser extent, depression, may reduce rates of suicides and suicide attempts. However, this hypothesis has not yet been adequately examined in a randomized clinical trial conducted specifically to test lithium's efficacy in preventing suicides. This clinical trial fills this gap. This study is feasible within the Department of Veterans Affairs (VA) because it is a large, integrated health system with existing programs for identifying patients at risk for suicide and delivering enhanced services. In VA, approximately 12,000 patients with depression or bipolar disorder survive a suicide attempt or related behavior each year, and 15% of them repeat within one year. Experimental treatment in this study will supplement usual care for major depression or bipolar disorder, as well as VA's standard, enhanced management for patients at high risk. The investigators will recruit 1862 study participants, from approximately 30 VA Hospitals. Participants will be patients with bipolar disorder or depression who have survived a recent episode of suicidal self-directed violence or were hospitalized specifically to prevent suicide. Randomly, half will receive lithium, and half will receive placebo. Neither the patients nor their doctors will know whether a particular person has received lithium or placebo. The treatment will be administered and the patients will be followed for one year, after which patients will go back to usual care. Recruitment will occur over 3 years. The investigators are primarily interested in whether lithium leads to increases in the time to the first repeated episode of suicidal behavior, including suicide attempts, interrupted attempts, hospitalizations specifically to prevent suicide, and deaths from suicide. In addition, this study will allow us to explore whether lithium decreases the t
Interventions
- DRUG Placebo
- DRUG Lithium
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 519 participants |
| Start Date | 2015-07-08 |
| Est. Completion | 2019-08-13 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01928446
The ClinicalTrials.gov registry entry for NCT01928446 describes a study currently listed as terminated, categorized as Phase 2. The registered enrollment target is 519 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is VA Office of Research and Development, which has 1,668 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT01928446 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01928446 about?
NCT01928446 is a clinical study titled "Lithium for Suicidal Behavior in Mood Disorders". Observational evidence and findings from clinical trials conducted for other reasons suggest that lithium, a drug used for the treatment of bipolar disorder, and, to a lesser extent, depression, may reduce rates of suicides and suicide attempts. However, this hypothesis has not yet been adequately e...
What is the current status of trial NCT01928446?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 519 participants. The study started on 2015-07-08. Estimated completion is 2019-08-13.
What interventions are being tested in trial NCT01928446?
The interventions under investigation include: Placebo (DRUG), Lithium (DRUG).
Who is sponsoring clinical trial NCT01928446?
This trial is sponsored by VA Office of Research and Development, which has 1,668 total clinical trials registered on ClinicalTrials.gov.
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