According to new findings published in a report in Medical Xpress, four commonly prescribed antipsychotic drugs that are usually prescribed off-label to treat schizophrenia and bipolar disorder among older adults over the age 40, lacked safety and effectiveness.
Researchers at the University of California, San Diego School of Medicine, Stanford University and the University of Iowa, and funded by the National Institute of Mental Health involved in the study found four antipsychotics: aripiprazole (Abilify), olanzapine (Zyprexa), quetiapine (Seroquel), and risperidone (Risperdal).
"Our study suggests that off-label use of these drugs in older people should be short-term, and undertaken with caution," said Dilip V. Jeste, MD, Estelle and Edgar Levi Chair in Aging, Distinguished Professor of Psychiatry and Neurosciences, and director of the Stein Institute for Research on Aging at UC San Diego, according to Medical Xpress.
Jeste, who was a lead researcher in the five-year study, found the patients treated with these drugs developed various disorders over a period of time. One third of the patients developed a higher risk of cardiovascular disease or diabetes within a year of treatment, while a quarter of the patients developed serious adverse and half of the patients developed non-serious adverse effects within two years, according to Medical Xpress. This shows the higher risk of using these drugs.
The researchers included a technique called "equipoise stratified randomization," where patients were supposed to use different study drugs while their physicians were allowed to take a call of excluding one or two drugs from the four antipsychotics. This was to avoid any higher risk to patients related to the drug. "Our goal was to ensure clinical relevance. We attempted to make the study as 'user-friendly' as possible, to allow the drugs the best chance of success, while seeking to minimize the amount of bias," Jeste explained in the report by Medical Xpress.
It was estimated that the randomized medication will be carried out for two years but due to the failure of the drug to function or side effects involved, it was called off in six months. Brief Psychiatric Rating Scale, a device which was used in the study to measure symptoms like delusions, hallucinations, unusual behavior, depression, and anxiety and the evaluations were made at every 6 weeks and then followed by every 12 weeks. But BPRS did not show any improvement over time.
"While there were a few significant differences among the four drugs, the overall risk-benefit ratio for the AAPs in patients over age 40 was not favorable, irrespective of diagnosis and drug," said Jeste, according to Medical Xpress. "When these medications are used off-label, they should be given in low dosages and for short durations, and their side effects monitored closely. Clearly, there is also a critical need to develop and test new interventions that are safe and effective in older people with psychotic disorders."
