Sanacora, Wilkinson Receive $12.6M in Funding for Ketamine Study
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 taken up 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)
Read more on the PCORI website.
Learn MoreAmerican Society of Ketamine Physicians, Psychotherapists and Practitioners Announces Standards of Practice in the Therapeutic Use of Subanesthetic Ketamine
BELLAIRE, Texas, Aug. 11, 2020 /PRNewswire/ — Ketamine, which was originally developed as an anesthetic, has emerged over the last two decades as the biggest breakthrough in 50 years for treatment-resistant depression and suicidality. Despite a growing body of research surrounding its use, guidelines establishing recommendations for best practices have been limited. The American Society of Ketamine Physicians, Psychotherapists and Practitioners (ASKP3) is a group of professionals dedicated to the safe and clinical use of ketamine for mental health disorders and pain conditions that was developed in 2016 and has over 400 members of various specialties. ASKP3 recognizes the lack of formal guidance and seeks to protect and foster the use of subanesthetic ketamine by providing recommendations for standards of practice. (more…)
Learn MoreNew Spravato FDA Approval Opens The Door to New Patients, Says Sandhya Prashad, M.D.
A new indication of Janssen’s ketamine based-nasal spray Spravato (intranasal esketamine) has been approved for rapid reduction of depression symptoms in those with major depressive disorder who have imminent risk of suicidal ideation, according to Houston-based psychiatrist Sandhya Prashad.
“The original indication for treatment-resistant depression meant that patients had failed treatments before. This is more for emergency cases” detailed Prashad. “It opens the door to the idea that this is a great treatment for severe depression with suicidal ideation. Traditional antidepressants can take weeks to start working. The availability of a medication that can start to reduce symptoms within one day is very significant.”
Spravato was first approved by the FDA strictly for patients with treatment-resistant depression, requiring at least two medication failures, and insurance often required patients to have three or four medication failures before this treatment was an option. This new approval opens the door for those with the most severe symptoms to be treated even if they have not failed multiple treatments.
Prashad, along with many of her colleagues and contemporaries in the industry, hopes that this will open up more leeway for providers to allow more at-risk individuals to receive this important new treatment.
“Ketamine or esketamine shouldn’t be the last line. It doesn’t have to be a last resort.” Prashad further detailed how ketamine and Spravato are so vital for treatment of depression with suicidal ideation. “This is a unique property of ketamine, this quick reduction in depressive symptoms that translates into reduction in suicidal thoughts. This is potentially life saving for some patients. Many of our patients will say that even if they still feel depressed after a ketamine infusion, they no longer feel like they want to attempt suicide. It’s an effect only seen with ketamine. Other treatments in psychiatry do not have this rapid, robust effect.”
This new treatment could not come at a more pertinent time. In 2017, suicide was the tenth leading cause of death in the United States, claiming the lives of over 47,000 people per the CDC WISQARS Leading Causes of Death Reports. This is more than twice the amount of homicides in the United States in the same year.
Ketamine was first synthesized in the early 1960s and has seen extensive use as an anesthetic and pain reliever since then, but new research in the last two decades has revealed its potential as a treatment for mood and pain disorders. Some doctors and medical professionals such as Thomas Insel, former Director of the National Institute of Mental Health, are saying ketamine may be “the most important breakthrough in antidepressant treatment in decades.”
Sandhya Prashad, MD – Dr. Sandhya Prashad, board-certified Psychiatrist based in Houston, has specialized in treatment-resistant depression and has been using ketamine in her practice since 2016. She is the founder and medical director of Houston Ketamine Therapeutics and Houston Deep TMS Therapy (www.sprashadmd.com) A graduate of Baylor College of Medicine for both Medical School and Psychiatry Residency, she has presented on the national level at conferences regarding the use of ketamine. She is a founding member and the President of the American Society of Ketamine Physicians, Psychotherapists, & Practitioners (www.askp.org), which is a non-profit organization created to advocate for the safe use of ketamine for mental illness and pain disorders and to expand access to ketamine therapy. Dr. Prashad was also named one of Houston’s Top Doctors by H Texas Magazine for 2017, 2018 and 2019.
The Janssen Pharmaceutical Companies of Johnson & Johnson released more information found in this press release.
About SPRAVATO® – SPRAVATO® (esketamine) CIII nasal spray is a non-selective, non-competitive antagonist of the N-methyl-D-aspartate (NMDA) receptor – an ionotropic glutamate receptor. It has a novel mechanism of action, meaning it works differently than currently available therapies for major depressive disorder (MDD).
SPRAVATO® is approved in the United States, in conjunction with an oral antidepressant, to treat adults with treatment-resistant depression (TRD) and depressive symptoms in adults with MDD with acute suicidal ideation or behavior. SPRAVATO® has been submitted for health authorities’ review for TRD and adults with MDD who have current suicidal ideation with intent in other markets around the world, including Europe. The FDA granted Breakthrough Therapy Designation to esketamine nasal spray for TRD in November 2013 and for MDD with imminent risk for suicide in August 2016.
About the Phase 3 Studies – ASPIRE I and ASPIRE II evaluated the efficacy and safety of SPRAVATO® in addition to a comprehensive standard of care in adult patients with major depressive disorder who had active suicidal ideation with intent. This is the first global clinical program to study this severely ill patient population, who have been typically excluded from antidepressant clinical trials, addressing a great unmet need. Patients were defined as those with major depression and active suicidal thoughts with intent. Every patient was treated with a comprehensive standard of care in both trials to safely and ethically conduct the studies. The comprehensive standard of care included initial hospitalization, a newly initiated or optimized oral antidepressant and twice-weekly treatment visits for four weeks.
The primary efficacy endpoint of the double-blind, randomized, placebo-controlled, multicenter studies was a reduction in depressive symptoms at 24 hours after the first dose, as measured by the Montgomery-Åsberg Depression Rating Scale (MADRS). The MADRS scale is a tool used to assess severity of depressive symptoms, allowing clinicians to evaluate 10 symptoms on a six-point scale to produce a total score of up to 60 points. A secondary efficacy endpoint measured improvement in severity of suicidality as measured by the revised Clinical Global Impression of Severity of Suicidality (CGI-SS-r), a seven-point scale developed by clinical experts that is a measure of the severity of suicidality as judged by the clinician’s global impression.
Originally posted on KetamineNews.
Learn MoreFive Things to Know About Esketamine
In March 2019, intranasal esketamine—a form of ketamine marketed as SPRAVATO™ CIII Nasal Spray*—was approved by the U.S. Food and Drug Administration (FDA) to treat patients with treatment-resistant depression (TRD). James Murrough, MD, PhD, Director of Mount Sinai’s Depression and Anxiety Center for Discovery and Treatment, was deeply involved in the research that led to esketamine’s FDA approval. In November 2019, he launched a TRD Program at the Icahn School of Medicine at Mount Sinai, featuring esketamine as a treatment option. Below, Dr. Murrough breaks down the top five things to know about esketamine based on his experience over the past decade.
Learn MoreKetamine May Treat Harmful Drinking Behavior by Rewriting Drinking Memories
A single dose of ketamine may be able to curb harmful drinking behavior by “rewriting drinking memories,” according to a study published Tuesday in the journal Nature Communications.
The Complete Guide to Ketamine Therapy for Depression, From Someone Who’s Tried It
When I entered the ketamine clinic for the first time, I started crying almost immediately. This was for two reasons: First and foremost, I was scared. After watching a documentary that introduced me to the subject and reading several accounts of ketamine infusion therapy, I knew a fair amount about the process. But the experience sounded strange, disorienting, and mysterious. Despite having done my research, I still didn’t feel like I had a good idea of exactly what it would feel like.
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