Bipolar Disorder Clinical Trial
— Li+Official title:
CSP #590 - Lithium for Suicidal Behavior in Mood Disorders
Verified date | April 2024 |
Source | VA Office of Research and Development |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Terminated |
Enrollment | 519 |
Est. completion date | August 13, 2019 |
Est. primary completion date | August 13, 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | N/A and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | Asheville VA Medical Center, Asheville, NC | Asheville | North Carolina |
United States | VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA | Boston | Massachusetts |
United States | Louis Stokes VA Medical Center, Cleveland, OH | Cleveland | Ohio |
United States | VA North Texas Health Care System Dallas VA Medical Center, Dallas, TX | Dallas | Texas |
United States | Atlanta VA Medical and Rehab Center, Decatur, GA | Decatur | Georgia |
United States | VA Eastern Colorado Health Care System, Denver, CO | Denver | Colorado |
United States | Edward Hines Jr. VA Hospital, Hines, IL | Hines | Illinois |
United States | Michael E. DeBakey VA Medical Center, Houston, TX | Houston | Texas |
United States | Richard L. Roudebush VA Medical Center, Indianapolis, IN | Indianapolis | Indiana |
United States | VA Southern Nevada Healthcare System, North Las Vegas, NV | Las Vegas | Nevada |
United States | VA Loma Linda Healthcare System, Loma Linda, CA | Loma Linda | California |
United States | William S. Middleton Memorial Veterans Hospital, Madison, WI | Madison | Wisconsin |
United States | Miami VA Healthcare System, Miami, FL | Miami | Florida |
United States | Clement J. Zablocki VA Medical Center, Milwaukee, WI | Milwaukee | Wisconsin |
United States | Minneapolis VA Health Care System, Minneapolis, MN | Minneapolis | Minnesota |
United States | Central Arkansas Veterans Healthcare System Eugene J. Towbin Healthcare Center, Little Rock, AR | North Little Rock | Arkansas |
United States | Orlando VA Medical Center, Orlando, FL | Orlando | Florida |
United States | VA Palo Alto Health Care System, Palo Alto, CA | Palo Alto | California |
United States | Corporal Michael J. Crescenz VA Medical Center, Philadelphia, PA | Philadelphia | Pennsylvania |
United States | Phoenix VA Health Care System, Phoenix, AZ | Phoenix | Arizona |
United States | VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA | Pittsburgh | Pennsylvania |
United States | VA Portland Health Care System, Portland, OR | Portland | Oregon |
United States | VA Sierra Nevada Health Care System, Reno, NV | Reno | Nevada |
United States | VA Salt Lake City Health Care System, Salt Lake City, UT | Salt Lake City | Utah |
United States | VA San Diego Healthcare System, San Diego, CA | San Diego | California |
United States | VA Puget Sound Health Care System Seattle Division, Seattle, WA | Seattle | Washington |
United States | Central Texas Veterans Health Care System, Temple, TX | Temple | Texas |
United States | Southern Arizona VA Health Care System, Tucson, AZ | Tucson | Arizona |
Lead Sponsor | Collaborator |
---|---|
VA Office of Research and Development |
United States,
Katz IR, Rogers MP, Lew R, Thwin SS, Doros G, Ahearn E, Ostacher MJ, DeLisi LE, Smith EG, Ringer RJ, Ferguson R, Hoffman B, Kaufman JS, Paik JM, Conrad CH, Holmberg EF, Boney TY, Huang GD, Liang MH; Li+ plus Investigators. Lithium Treatment in the Prevent — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Time to Event Hazard Rate. Event is a First Repeated Episode of Suicide Related Event, Including Suicide Attempts, Interrupted Attempts and Hospitalizations for Prevention of Attempts. | The primary hypothesis tested is that lithium augmentation of enhanced usual care is superior to enhanced usual care plus placebo for the prevention of repeated episodes of suicidal self-directed violence over time. The investigators posit a one-year repeat rate of 15% in the placebo group and a 37% reduction of events in the intervention group.
Suicidal self-directed violence includes non-fatal suicide attempts, interrupted attempts (attempts interrupted by patient or by others), hospitalization to prevent suicide and deaths from suicide. |
1 year | |
Primary | Number of Compliant Participants With Episode of Self-directed Violence (Per Protocol Analyses) | Compliance is defined as taking 80% or more of study medication over the entire clinical trial.
Episode of self-directed violence is defined as: First Repeated Episode of Suicide Related Event, Including Suicide Attempts, Interrupted Attempts, Hospitalization to Prevent Suicide and death. |
1 year | |
Secondary | Number of Participants With Subtypes of Suicidal Self-directed Violence for All Recurring Events | Subtypes of suicidal self-directed violence:
Self-directed violence; Interrupted self-directed violence; Hospitalization to prevent suicide; Death from suicide - there were too few deaths in the study, making data insufficient to perform analysis. |
1 year |
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