Project Summary

In the United States every 10 minutes a person dies by their own hand. It is estimated that 1.5 million make a suicide attempt and 10 million Americans seriously think of suicide every year. The situation is only worsening and has now become a public health crisis. There has been a 35% increase in suicide rates in the last twenty years with an alarming increase in the younger population, age 18 – 34 years old, in whom suicide is currently the second leading cause of death. The COVID-19 pandemic after-effects have the potential to convert this wave of suicides into a tsunami. A vast majority of suicides and suicide attempts are associated with clinical depression. Acute suicidal depression (ASD) is a life-threatening illness where there is an intent of imminent suicide, or an actual attempt has already been made. A number of psychotherapies and measures such as suicide hotlines have helped in decreasing suicide attempts in the community, but once ASD has set in, it requires rapid reversal. This can be done only with medical treatments such as electroconvulsive therapy (ECT) and subanesthetic intravenous ketamine (KET) with known efficacy in ASD. ECT has been available for nearly 80 years and though its administration requires brief anesthesia, and it can cause short-term memory deficits, it is the most effective treatment for ASD and is recommend by all treatment guidelines. KET has been available for last 20 years as a treatment of ASD and has been shown to have a specific anti-suicidal effect. However, there is a brewing crisis in the treatment of ASD treatment in the current health system. Patients suffering from ASD are usually admitted as inpatients for safety and started on oral antidepressants (which can take 6 – 12 weeks to have an effect) and given nursing care. They are then discharged from the hospital, usually within 4 -5 days as soon as immediate safety concerns are ameliorated or insurance runs out. The immediate post-discharge period has the highest risk for repeat suicide attempts and completed suicides. The research team conducted a survey of clinicians (81 responders) and patients (37 responders) and found that there is a knowledge-gap. An important reason for the inadequate treatment of ASD is the lack of evidence from large scale, comparative studies of available treatments such as ECT and KET with known efficacy in ASD. In the absence of data to guide rational treatment choice, neither treatment is being used adequately. To address this critical knowledge gap, the research team proposes a real-world trial in ASD patients who have been referred to the ECT service for treatment. Invited patients will have a 50:50 chance of either receiving ECT or KET treatment for 4 weeks. Patients will rate their depression and suicidality, be administered tests by trained raters, and also have their memory tested. The team’s hypothesis is that KET will be nearly as good as ECT in its effectiveness for the treatment of ASD. In addition, at the end of the treatment period, patients will receive Collaborative Assessment and Management of Suicidality (CAMS) psychotherapy which develops a therapeutic alliance with the patient to decrease suicidal thoughts. The team will investigate whether CAMS works better with ECT or KET treatment. The study will evaluate 1500 ASD subjects at 10 – 13 sites spread across the country. Nine sites led by some of the leading investigators in the field have already committed to participating. A feasibility trial with 140 subjects will first be conducted to assess strengths and barriers for recruitment and study procedures. A stakeholder committee consisting of patients and their families, representatives from patient advocacy organizations such as National Alliance on Mental Illness (NAMI) and American Foundation for Suicide Prevention (AFSP), hospital administrators, and health plan executives will also be created. The Stakeholder committee will provide suggestions for study design and monitor its implementation during the subsequent full five-year phase of the study. Data will be managed and analyzed by an independent investigator and team at the Cleveland Clinic. Results will be shared with the participating patients, general community, and the scientific community. This study will be the largest clinical trial ever conducted with ASD patients and will provide invaluable data regarding how this life-threatening condition can be treated.

Project Information

Amit Anand, MD
Bo Hu, PhD, MS
Brigham and Womens Hospital, Boston
$28,520,391 *

Key Dates

78 months *
2022

*All proposed projects, including requested budgets and project periods, are approved subject to a programmatic and budget review by PCORI staff and the negotiation of a formal award contract.

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Last updated: August 5, 2022