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US Department of Health and Human Services in Washington DC.
CNN
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of U.S. Department of Health and Human Services Following the suicide of a study participant, Columbia University’s Institute of Psychiatry discontinued the human study, according to research documents.
An HHS spokesperson told CNN Thursday the agency’s view. Human Research Protection Agency was investigating the Psychiatric Institute, which “restricted its ability to conduct HHS-sponsored human research.”
“The Office for Human Research Protection (OHRP) is committed to protecting the rights, well-being and welfare of those who participate in research conducted or supported by HHS. We take it seriously and have procedures in place to ensure those protections are in place,” an HHS spokesperson said in a statement to CNN.
The New York State Psychiatric Institute, which is affiliated with Columbia University, announced in early June that it had voluntarily suspended all research studies involving humans.
The investigation began after reports that participants in a study testing Parkinson’s drugs for late-life depression died by suicide during study enrollment, according to research documents held by the U.S. National Library of Medicine. The patient was part of a group of participants who received a placebo rather than the drug, according to the study. research documents.
When asked about the reported patient suicides, the Institute of Psychiatry said it was “unable to provide specific details about the individuals involved in the research study.”
This research was led by Dr. Brett R. Rutherfordwas an associate professor of psychiatry at Columbia University. was funded by National Institute of Mental Health. Rutherford’s research has received about $15 million in funding from the NIMH since 2010, according to the National Institutes of Health. database.
Rutherford resigned from the Institute on June 1 and is no longer on the faculty at Columbia University, according to the New York Institute of Psychiatry. CNN has attempted to contact Rutherford for comment.
In 2018, Rutherford began testing the central nervous system drug levodopa as a treatment for late-life depression, according to the documents. clinical trials.gov.
The central hypothesis of the Institute’s study is that levodopa may help reduce late-life depression “by enhancing dopamine function in the brain and ameliorating decline in cognitive and motor skills.” It is said that protocol summary form.
For the 8-week study, Professor Rutherford recruited 90 adults aged 60 and older with depressive disorders, slow processing, or slow walking, as outlined on the protocol summary form. The goal was to recruit A total of 51 participants were enrolled, according to the trial documentation.
Of the 51 participants, 20 subjects were found to be ineligible or did not continue the study after enrollment, and the remaining 31 were divided into two groups, one receiving levodopa daily. one received a placebo. In documents about research.
About two weeks after the shutdown of the New York State Psychiatric Institute, HHS restricted funding for research on humans at the institute, according to a statement. A spokeswoman for the institute said the review is expected to be completed next month.
NIH representative Amanda Fine said the NIH is working closely with the Office for the Protection of Human Research, which is currently investigating. Fine said the NIH cannot comment on matters currently under consideration.
Editor’s Note: If you or a loved one have had suicidal thoughts, call the 988 Suicide and Crisis Lifeline, formerly known as the National Suicide Prevention Lifeline, to connect you with a trained counselor. please.
