Ethical Considerations for Clinical Research and Off-label Use of Ketamine to Treat Mood Disorders: The Balance Between Risks and Benefits

TitleEthical Considerations for Clinical Research and Off-label Use of Ketamine to Treat Mood Disorders: The Balance Between Risks and Benefits
Publication TypeJournal Article
Year of Publication2017
AuthorsZhang, MW, Ho, RC
JournalEthics and Behavior
Date Published2017
Publication Languageeng
ISBN Number10508422
KeywordsANTIDEPRESSANTS , Clinical , Conflict , Deception , ECOLOGICAL , Informed , KETAMINE , Mental , mood , Moral , off-label , PATENTS , Pharmaceutical , research , Therapeutic
AbstractPrevious research conducted in 1999 highlighted ethical concerns behind challenge studies inducing psychosis with ketamine and made recommendations to enhance ethical standards. Recently, a plethora of clinical trials have evaluated the efficacy of ketamine to treat mood disorders, which lead to complex ethical issues. Pharmaceutical companies and researchers hope to profit by developing patentable variations on ketamine for treating depression. Media have labeled ketamine as a “miracle” antidepressant. Some clinics offer expensive off-label use of ketamine to treat mood disorders. This article examines the ecological validity of ketamine trials, measures to protect patients, informed consent procedures, financial inducements to participants and conflict of interest of researchers, therapeutic misconception, concealment, and deception. Further recommendations are purposed to improve ethical standard of clinical research involving ketamine.
NotesZhang, Melvyn W. 1; Email Address: Ho, Roger C. 2; Affiliation: 1: Biomedical Global Institute of Healthcare Research and Technology (BIGHEART), National University of Singapore 2: Department of Psychological Medicine, National University of Singapore; Source Info: Nov/Dec2017, Vol. 27 Issue 8, p681; Subject Term: CLINICAL medicine research; Subject Term: ANTIDEPRESSANTS; Subject Term: CONFLICT of interests; Subject Term: DECEPTION; Subject Term: INFORMED consent (Medical law); Subject Term: KETAMINE; Subject Term: PATENTS; Subject Term: PHARMACEUTICAL industry; Subject Term: RESEARCH ethics; Subject Term: RESEARCH personnel; Subject Term: OFF-label use (Drugs); Subject Term: RESEARCH subjects (Persons); Subject Term: MENTAL illness drug therapy; Subject Term: MORAL & ethical aspects; Author-Supplied Keyword: conflict of interest; Author-Supplied Keyword: ecological validity; Author-Supplied Keyword: ketamine; Author-Supplied Keyword: mood disorders; Author-Supplied Keyword: therapeutic misconception; NAICS/Industry Codes: 325411 Medicinal and Botanical Manufacturing; NAICS/Industry Codes: 325410 Pharmaceutical and medicine manufacturing; NAICS/Industry Codes: 541110 Offices of Lawyers; NAICS/Industry Codes: 541199 All Other Legal Services; NAICS/Industry Codes: 414510 Pharmaceuticals and pharmacy supplies merchant wholesalers; NAICS/Industry Codes: 424210 Drugs and Druggists' Sundries Merchant Wholesalers; NAICS/Industry Codes: 325412 Pharmaceutical Preparation Manufacturing; Number of Pages: 19p; Document Type: Article