When physicians interviewed patients hospitalized after their initial psychotic episode, they were startled to learn that in many cases, “people began experiencing changes in cognition, behavior, and perception for months or years before psychosis struck,” says Dr. Robert Heinssen of the National Institute of Mental Health in the recent Science article, A Change of Mind. “There’s an emerging risk state that precedes schizophrenia.”
Researchers across the world are now pursuing the identification of people who are afflicted with this risk state, referred to as the “psychosis prodrome.” And for the first time ever, a regulatory pathway is being pursued by those who aim to leverage prodromal science to treat early-stage psychosis.
According to the article, Boehringer Ingelheim (BI) is conducting a clinical trial focused on glutamate, a neurotransmitter that is impaired in people with schizophrenia and those at risk. The drug was originally studied to improve cognitive impairment in Schizophrenia, but now has expanded into prevention. Michael Sand, the Boehringer Ingelheim scientist overseeing the trial, states “We welcome prevention in other diseases, like cancer and heart attacks, even for those whose risk is only modest… the stigma and tragedy that mark a schizophrenia diagnosis, and our ability to identify those at substantial risk, make preventing it with safe and effective therapies even more urgent.”
To assess cognitive impairment in the trial, BI is using a composite score of the BAC App, a tablet-based cognitive assessment battery. Dr. Richard Keefe, CEO of NeuroCog Trials, states “By identifying a psychosis prodrome state, we are now able to utilize the latest science and technology to investigate the possible prevention of these devastating illnesses.” NeuroCog Trials is supporting this study by providing outcome measure training, rigorous data review, and leading an adjudication committee that determines whether these prodromal patients convert to psychosis.