Contemporary clinical trials

Comparing intravenous ketamine and nasal esketamine for treatment-resistant depression to see if they work equally well

Updated

Abstract

A total of 400 patients will be randomized to receive 8 treatments of either intravenous ketamine or intranasal esketamine over 4 weeks.

  • The primary outcome measures change in depression severity using the Quick Inventory of Depressive Symptomatology (QIDS) after 4 weeks.
  • The study is designed to determine if intravenous ketamine is non-inferior to the FDA-approved esketamine within a margin of 1.6 on the QIDS.
  • Secondary outcomes include response and remission rates, as well as assessments of anxiety severity, quality of life, and patient satisfaction.
  • The study will explore whether treatment response differs for patients with treatment-resistant depression who also experience anxious distress.
  • Patient preference may influence outcomes and will be examined as part of the study.

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Full Text

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Funding

Competing interests

Declaration of competing interest The authors declare the following financial interests/personal relationships which may be considered as potential competing interests: (In the last 36 months, Dr. Wilkinson has received contract research funding from Oui Therapeutics for the conduct of clinical trials (administered through Yale University); he has consulted or provided DSMB services for LivaNova, Mind Medicine, Neumora, and Sooma Medical. Dr. Harding has consulted to Janssen, Compass Pathways, and GH Reseach, Otsuka, Abbie and Lilly Pharmaceuticals. Dr. Kitay reports consulting fees from Janssen, Biogen, Boehringer Ingelheim, and Senseye. He has received contract research funding from Otsuka Pharmaceuticals (administered through Emory University). Dr. Prashad has served as the President of the American Society of Ketamine for Physicians, Psychotherapists and Practitioners (unpaid role). Dr. Parikh reports clinical trial contract funding from Aifred, Janssen, Sage and Compass and consulting fees from Otsuka, Boehringer Ingelheim, and Mensante. Dr. Sanacora has served as consultant to AbbVie, Ancora, Aptinyx, Atai, Axsome Therapeutics, Biogen, Biohaven Pharmaceuticals, Boehringer Ingelheim International GmbH, Bristol-Myers Squibb, Clexio, Denovo Biopharma, Douglas Pharmaceuticals, EMA Wellness, Embark, Engrail Therapeutics, Freedom Biosciences, GH Research, Gilgamesh, Holmusk, Intra-Cellular Therapies, Janssen, Levo therapeutics, Lilly, Merck, Navitor Pharmaceuticals, Neumora, Neurocrine, Newleos Therapeutics, Novartis, Noven Pharmaceuticals, Otsuka, Perception Neuroscience, Relmada Therapeutics, Seaport, Pharmaceuticals, Sage Pharmaceuticals, Seelos Pharmaceuticals, Supernus, Taisho Pharmaceuticals,Transcend Therapeutics, Usona Institute, Vistagen Therapeutics, and XW Labs; and received research contracts from Johnson & Johnson/Janssen, Merck, and the Usona Institute over the past 36 months. Dr. Sanacora holds equity in Biohaven Pharmaceuticals, Freedom Biosciences, Gilead, Newleos Therapeutics, Oui Therapeutics, Relmada, and Tetricus. He is a co-inventor on a US patent (#8778,979) held by Yale University and a co-inventor on US Provisional Patent Application No 047,162–7177P1 (00,754) filed on August 20, 2018, by Yale University Office of Cooperative Research. Yale University has a financial relationship with Janssen Pharmaceuticals and may receive financial benefits from this relationship. The University has put multiple measures in place to mitigate this institutional conflict of interest. Questions about the details of these measures should be directed to Yale University's Conflict of Interest office.
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