Gerard Sanacora, MD, PhD, George D. and Esther S. Gross Professor of Psychiatry, and Samuel Wilkinson, MD associate professor of psychiatry, have received $12.6 million in funding from the Patient-Centered Outcomes Research Institute (PCORI) for the study “Comparative Effectiveness of Racemic Ketamine versus S-Ketamine (Spravato) for Depression.”
The project will compare two new treatments for treatment-resistant depression: racemic ketamine (IV ketamine), delivered intravenously, and esketamine (Spravato), delivered as a nasal spray.
Treatment-resistant depression is a type of depression where people do not experience benefits with standard oral antidepressants. The Yale study will be the first to directly compare the two ketamine treatment approaches.
IV ketamine has not been approved by the U.S. Food and Drug Administration to treat depression, but Spravato has. Insurance companies often decline to pay for IV ketamine treatments because of the lack of FDA approval, but until now no study has compared the two treatment options for effectiveness from the patient’s perspective.
Yale researchers will work with scientists from Emory University in Atlanta, the University of Michigan, and three community sites to recruit about 400 people with depression who seek treatment with either IV ketamine or Spravato. These patients will be randomly assigned treatment by either IV ketamine or Spravato.
The patients will give reports on their depression, anxiety, and satisfaction with treatment. The researchers will observe the patient’s response to the drugs and the tolerability of treatments.
The data will be used by the researchers to learn whether IV ketamine and Spravato have similar antidepressant effects or whether they induce different effects.
“This project was selected for PCORI funding not only for its scientific merit and commitment to engaging patients and other healthcare stakeholders, but also for its conduct in real-world settings. It has the potential to answer an important question and fill a crucial evidence gap,” said PCORI Executive Director Nakela L. Cook, M.D., MPH. “We look forward to following the study’s progress and working with (the researchers) to share its results.”
The study was selected through a highly competitive review process in which patients, caregivers and other stakeholders joined scientists to evaluate the proposals. It was selected for funding through a PCORI program designed to support research that produces results that are broadly applicable to a diverse range of patients and care situations and can be more quickly adopted in routine clinical practice.
Additional Academic Sites:
Brandon Kitay, MD, PhD (Emory)
Sagar Parikh MD (Univ of Michigan)
Community Sites:
Lisa Harding, MD, assistant clinical professor of psychiatry, Yale School of Medicine (Depression MD; Milford, CT)
Sandhya Prashad MD (Advanced Therapies for Treatment-Resistant Depression; Houston, TX)
Rachel Dalthorp, MD (LifeStance Health, Oklahoma City, OK)