Lithium for Suicidal Behavior in Mood Disorders

• Status: Terminated
• Trial end date: 2019-12-19
• Target enrollment: 0
• Participant gender: All

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 total number of suicidal behaviors, and whether it has comparable effects on impulsive and non-impulsive behaviors. If there is an effect of lithium, the investigators will be interested in whether or not it could be attributed to improved control of the underlying mental health condition, or, alternatively, whether it represents a direct effect of suicide-related behavior.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: VA Office of Research and Development
• Treatments: Lithium Carbonate

Criteria

Inclusion Criteria:

• Must be a Veteran of the United States Armed Forces

• Survived an episode of suicidal self-directed violence (including suicide attempts and interrupted attempts) that occurred within six months of admission to the study, or they were admitted within the past six months to a mental health inpatient unit specifically to prevent suicide

• Have a diagnosis of an affective disorder meeting DSM-IV-TR (2000) criteria for Bipolar I Disorder, Bipolar II Disorder, or current or recurrent Major Depressive Disorder

• Are able and willing to identify one or more family members, friends, or other contacts and give permission for both clinical providers and the Research Team to contact them if the patient cannot be reached

• Are able to provide informed consent

• There is concurrence from the patient's mental health provider about inclusion/exclusion criteria and confirmation of the providers' willingness to work with the research team in managing the patient during the course of the study. The provider responsible for the patient's general medical care has been made aware of the participation

• Must be registered at a VA Medical Center

Exclusion Criteria:

• Schizophrenia or schizoaffective disorder

• Cognitive impairment defined as a Brief Orientation Memory and Concentration Test score > 10

• Lack of decision-making capacity to evaluate the risks versus the benefits of participation as determined by Jeste's brief instrument for assessing decisional capacity, or adjudication of incompetence and the appointment of a guardian or conservator

• Six or more previous lifetime suicide attempts as ascertained through SPAN, reports from family, or patient self-report

• Current or recent (within six months) use of lithium

• History of significant adverse effects of lithium as ascertained through the medical record or self-report

• Unstable medical conditions or specific medical comorbidity:

• Congestive heart failure by Framingham criteria

• QTc greater than or equal to 450 ms for men and greater than or equal to 460 ms for women

• Chronic renal failure defined by national Kidney Foundation Disease Outcome Quality Initiative (KDOQI) criteria

• Any possibility of being pregnant or not on appropriate birth control

• Lactation and breastfeeding

• Concurrent medications:

• All diuretics except amiloride

• Haloperidol

• Clozapine

• Active substance abuse:

• Active alcohol or opiate dependence requiring medically supervised withdrawal and stabilization

• Active cocaine, methamphetamine, other stimulant, hallucinogen, or cannabis abuse requiring stabilization

• Enrollment in another randomized interventional clinical trial