Low-dose Amisulpride Effective in Late-onset Psychosis
By Anne Harding
NEW YORK—Low-dose amisulpride (100 mg daily) is superior to placebo in reducing psychotic symptoms in patients with very late-onset schizophrenia-like psychosis, according to results from the ATLAS trial.
Very late-onset schizophrenia-like psychosis is the third-most common mental-health diagnosis in older people after dementia and depression, Dr. Robert Howard of University College London in the U.K. and colleagues note in The Lancet Psychiatry, online June 4. These patients are diagnosed at age 60 or later, have positive symptoms and face an increased risk of social dysfunction, institutionalization and mortality.
"Clinicians' concerns about the poor efficacy and substantial risks associated with the prescribing of antipsychotic drugs for older people with Alzheimer's disease, compounded by the characteristic impairment of insight into the potential value of treatment among patients with very late-onset schizophrenia-like psychosis, have resulted in less than half of eligible patients currently receiving treatment," they add.
Until now, no randomized controlled trials of antipsychotic treatment had been conducted in very late-onset schizophrenia-like psychosis, Dr. Howard and his team write, although there is some evidence that atypical antipsychotics may be effective.
The researchers randomly assigned 101 patients to one of three groups: amisulpride 100 mg orally daily during both the first and second 12-week treatment periods of the study (stage 1 and 2, respectively); amisulpride followed by placebo; or placebo followed by amisulpride. The patients were recruited from 25 old-age psychiatry services in the U.K.
Ninety-two participants (91%) started taking trial medication, 59 (64%) completed stage 1, and 34 (58%) completed stage 2. Brief Psychiatric Rating Scale (BPRS) scores improved 7.7 points in patients on active treatment compared to those on placebo (P=0.0002), with a mean increase of 11.9 points with amisulpride and 4.2 points for the placebo group.
In the second stage of the study, patients who continued on amisulpride had a mean improvement of 1.1 in BPRS score, while patients switched to placebo from amisulpride deteriorated by 5.2 points (P=0.024).
Patients on amisulpride were significantly less likely to drop out due to lack of efficacy than those taking placebo, but they had a non-significantly increased risk of serious adverse events.
"The proportion of dropouts is frustrating since the findings showed that many patients who chose to stay in care responded robustly to the medication," Dr. Carl I. Cohen of SUNY Downstate Medical Center in Brooklyn writes in a comment accompanying the study.
"Howard and colleagues found that people taking amisulpride did not perceive any notable improvement in their quality of life and 11 (18%) of all 61 medicated patients stopped treatment because of side effects versus three (10%) of 31 people," he adds. "People who are reluctant to take medications might see the risk of adverse events as too high."
Comorbidities can make it more difficult to diagnose very late-onset schizophrenia-like psychosis, Dr. Cohen notes. "A final concern is that the precise age of onset of the disorder is difficult to determine and a diagnosis of very late-onset schizophrenia-like psychosis might be based on age at clinical contact rather than onset age. Because of these concerns, the findings reported by Howard and colleagues should be viewed as encouraging but provisional."
The study was funded by the U.K. National Institute for Health Research.
SOURCE: https://bit.ly/2MkS4qp and https://bit.ly/2JGaQ9X
Lancet Psychiatry 2018.
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