Research teams of founding members of Mass General Brigham, Brigham and Women’s Hospital (BWH) and Massachusetts General Hospital (MGH), have been approved for more than $50 million in funding awards by Patient-Centered Outcomes Research Institute (PCORI) for studies focused on addressing two important mental health issues. Both projects are large-scale, high-impact research trials that will invite patients to participate at sites across the country, including MGH, Brigham and Women’s Faulkner Hospital (BWFH), and McLean, all members of the Mass General Brigham system.
Reverse acute suicidal depression
The BWH research team, led by Amit Anand, MD, director of translational clinical trials in the Department of Psychiatry, will receive more than $28.5 million in funding for work comparing the effectiveness of two treatments for the condition acute suicidal depression (ASDS). Each year, 10 million Americans seriously consider suicide and 1.5 million attempt it. Among those aged 18 to 34, suicide is now the second leading cause of death.
People with ASD have imminent suicidal intent or have attempted suicide. Once ASDS has taken hold, it requires prompt reversal with medical treatment such as electroconvulsive therapy (ECT) or intravenous ketamine subanaesthetic (KET). But many patients receive inadequate treatment –; some are given antidepressants and discharged within 4-5 days of hospitalization. Anand and colleagues propose a real-world trial in ASDS patients to compare the effectiveness of ECT and KET to better inform patient care. Study participants will receive one of two treatments along with Collaborative Assessment and Management of Suicidality (CAMS) psychotherapy, which develops a therapeutic alliance with the patient to reduce suicidal thoughts. The study will include 1,500 participants with ASDS, recruited from sites across the country, including BWFH. The research team will also form a stakeholder committee comprised of patients, their families, and representatives of patient advocacy organizations to provide suggestions for study design and oversee its implementation.
Suicide rates have risen alarmingly and we urgently need to improve our understanding of how to treat and reverse ASD. Our study will be the largest clinical trial ever conducted with patients with ASD and will provide invaluable data on how we can treat this life-threatening disease. »
Amit Anand, MD, Director of Translational Clinical Trials, Department of Psychiatry
“This collaborative research aims to increase our understanding of effective interventions for optimal clinical outcomes that can reduce suffering and prevent suicides,” said Bo Hu, Ph.D., of Cleveland Clinic’s Lerner Research Institute and co-investigator. grant principal. “By conducting a study on this large scale and using state-of-the-art data analysis methods, we will fill critical gaps in knowledge about the treatment of ASD.”
Treating Bipolar Depression
The MGH team, led by Andrew A. Nierenberg, MD, director of the Dauten Family Center for Bipolar Treatment Innovation, and Andrea Foulkes, PhD, director of biostatistics, will use their nearly $25 million in funding to compare the effectiveness of four treatments for bipolar depression. Bipolar disorder is characterized by episodes of depression that include low mood and energy, and episodes of mania that are associated with high mood, high energy, and lack of sleep. During depressive episodes, people may experience an increase in suicidal thoughts, suicidal behaviors, and suicide deaths. To date, no studies have compared several approved treatment options for depression in bipolar disorder. The MGH team plans to evaluate the safety and effectiveness of four treatments: cariprazine, lurasidone, quetiapine, and a commonly used but unstudied combination antipsychotic and antidepressant. They also plan to identify specific clinical characteristics in patients that can help with drug selection. The study aims to recruit 2,800 participants from sites across the country, including MGH and McLean Hospital. The research team will contact and engage representative stakeholders (patients with bipolar depression, clinicians, insurers) and incorporate their input into all areas of study design, implementation and dissemination of study results. .
“Comparative efficacy studies are needed to answer critical questions about how best to treat people with bipolar disorder who have major depressive episodes,” Foulkes said. “Our goal is to provide solid, scientifically rigorous data to help clinicians and their patients make informed decisions about a treatment plan.”
“The results of this study will help patients with bipolar depression seeking treatment, as well as the clinicians treating them, decide which medication to try first and what to choose next if the first option doesn’t work or has unbearable side effects. , “said Nierenberg.
“These studies were selected for PCORI funding because of their scientific merit and commitment to involving patients in leading major research efforts in acute suicidal depression and bipolar depression,” said the executive director. du PCORI, Nakela L. Cook, MD, MPH. “The studies have the potential to fill important gaps in relevant evidence for a range of health care decision makers and help them better assess their care options.” We look forward to following the progress of the studies and working with the research teams to share their results.
Both studies were selected for funding under a PCORI initiative to support large-scale, high-impact comparative efficacy research trials in a multi-phase format that allows testing and refining of the study approach. The studies will involve an initial feasibility phase in order to maximize the probability of complete success of the trials. The studies were selected through a highly competitive review process in which patients, caregivers and other stakeholders joined scientists to assess the proposals.
Both awards have been approved pending completion of business and programmatic reviews by PCORI staff and issuance of formal award contracts.
Brigham and Women’s Hospital