Brian Barnett, MD, a Cleveland Clinic psychiatrist, is helping to lead a national trial that is working to evaluate whether intravenous ketamine can be an effective alternative for patients with suicidal thoughts and ideation.
The study aims to determine whether IV ketamine can be a rapid, effective treatment for individuals with acute suicidal depression compared to ECT, which has side effects such as memory loss coupled with stigma and misinformation around the treatment. The study is one of the first to document long-term data and outcomes, Dr. Barnett, a site principal investigator for the trial and the director of the psychiatric treatment-resistance program at Cleveland Clinic Neurological Institute, told Becker’s.
“If you’re suicidal and go to a psychiatric inpatient unit, they’re changing your medications but really they’re just waiting for your suicidal thoughts to go away so that you can leave after three or four days,” he said. “But it would be really nice to have another option for those patients, especially on the inpatient side.”
Researchers aim to enroll 1,500 participants, who will be followed for six months and assessed using standardized rating scales. Participants will be randomly assigned to receive either 12 ECT sessions or eight IV ketamine sessions over four weeks, with ketamine dosed at 0.5 milligrams per kilogram of body weight.
The study includes follow-up visits at one month, three months and six months and allows participants access to Collaborative Assessment and Management of Suicidality therapy post-treatment. There are 11 sites hosting the trial, with potential for growth over the next five remaining years of the trial, according to Dr. Barnett.
Baltimore-based Johns Hopkins University, Boston-based Massachusetts General Hospital, New York City-based Mount Sinai School of Medicine and Houston-based Baylor College of Medicine are among the trial hosts.
ECT stigma, side effects
Although research has shown electroconvulsive therapy is effective in treating depression and reducing suicidal ideation, a stigma surrounding the treatment persists.
“You’d think it’d be painful or we’re doing it without anesthesia, but it’s actually a very routine procedure today,” Dr. Barnett said. “Patients go under anesthesia for a short period; there’s no pain. The most common side effects are headache, muscle pain and nausea from the anesthesia. But more than half of patients do get temporary memory loss.”
The temporary memory loss and short-term cognitive impairment can deter patients. Some patients with comorbidities, however, cannot take anesthesia, and ketamine treatment could be an alternative, with side effects disappearing once the transfusion is over.
“In general our thinking is the more effective treatments that we have, the better, because there’s always reasons why somebody can’t do one or the other,” he said.
A real-world trial
Unlike traditional, highly selective FDA trials, the ketamine study is a real-world trial that includes a wider patient population, excluding only those with psychosis or serious cardiac instability.
“We really want this study to reflect what patients look like in the community, people who are actually going to outpatient clinics and people who are actually in inpatient units in psychiatry,” Dr. Barnett said. “So the goal of these [Patient-Centered Outcomes Research Institute]-funded studies is to really do studies that can be helpful to clinicians in the community and reflective of the real-world population.”
The study includes inpatient and outpatient participants who are frequently reporting feeling suicidal, which can present challenges. Inpatient treatment involves ongoing monitoring by clinical staff, whereas outpatient participants will be assessed by a psychiatrist, Dr. Barnett said. The psychiatrist will determine whether it’s safe to keep them in outpatient treatment or if admission is needed.
