The New York State Psychiatric Institute has suspended ALL human research trials by a watchdog after a person in the Parkinson’s disease drug trial committed suicide
- Dr. Bret R. Rutherford, associate professor of psychiatry at Columbia University, led the study, which tested the drug for Parkinson’s disease
- The research study on the drug was then fully completed in May 2023 – just weeks before the federal order to end all human trials on June 12.
The New York State Psychiatric Institute has suspended all human research trials after a person taking part in a trial of a drug for Parkinson’s disease committed suicide.
A total of 417 research studies, with a budget of $86 million, have been halted as federal regulators probe the center’s safety protocols after the death of a man who was part of the group testing levodopa – an agent dopamine replacement.
Dr. Bret R. Rutherford, associate professor of psychiatry at Columbia University, led the study – which tested the drug for Parkinson’s disease.
He has since resigned from his prestigious position.
It’s unclear when the suicide occurred, but the study – which received $736,579 in funding – was temporarily suspended by the National Institute of Mental Health in January 2022, first reported by Spectrum.
Dr. Bret R. Rutherford, an associate professor of psychiatry at Columbia University, led the study, which tested the drug for Parkinson’s disease. He has since resigned from his prestigious position
Levodopa (pictured) is a dopamine replacement agent being used in trials for the treatment of Parkinson’s disease
The research study on the drug was then fully completed in May 2023 – just weeks before the federal order to end all human trials on June 12.
According to clinictrials.gov, the person who died by suicide was assigned to the study’s placebo group, meaning they weren’t actually receiving the drug.
Their identities have not been confirmed, and the New York State Psychiatric Institute has not specifically confirmed that the patient died during the trial.
It has also not been confirmed whether the deceased patient was previously taking antidepressants.
Dr. Rutherford’s levodopa trial for late-onset depression attempted to enroll 90 adults over the age of 60 with mild to moderate depression.
Ultimately, the study was able to recruit 51 patients – but 20 of them either dropped out or were deemed ineligible. The other 31 received either levodopa or a placebo.
However, problems arose after it was reported that some of the human subjects had just finished taking their antidepressants a few days earlier – which goes against the study protocol.
In addition, stopping the use of antidepressants is linked to an increased risk of suicide.
Emily Roberts, a former research assistant in Dr Rutherford’s lab, told Spectrum that recruiting was difficult – and in an effort to recruit enough people, some criteria have been “loosened”.
The New York State Psychiatric Institute (pictured) has suspended all human research trials after a person taking part in a Parkinson’s disease drug trial committed suicide
Many of the people who joined the study were “financially insecure,” which Roberts says may have been a motivating factor.
Roberts told Spectrum and the NYTimes, “I was disappointed in the rigor of the research there.”
“In a study that is difficult to enroll in, you will push the boundaries of those who are eligible.”
The New York State Psychiatric Institute spokesperson said “the company’s top priority is the health and safety of those engaged in our award-winning research programs.”
They work “to assist federal agencies in their audit and have subsequently restructured and strengthened its compliance and research oversight programs across the institution.”
