These findings suggest that monitoring studies increase the risk for postictal psychiatric events, which neurologists need to be familiar with, as they represent important morbidity associated with these studies.
Objective
In spite of growing numbers of elderly there are few treatment studies on late-life bipolar disorder (BD). This was a 12-week prospective, open-label trial to assess efficacy and tolerability of adjunct asenapine in non-demented elderly (≥60 years) with sub-optimal previous response to BD treatments.
Methods
Asenapine was initiated at 5 mg/day and titrated as tolerated. Effects on global psychopathology were measured with Clinical Global Impression, Bipolar version (CGI-BP) and the Brief Psychiatric Rating Scale (BPRS). Mood polarity severity was measured with the Hamilton Depression Rating Scale (HAM-D), Montgomery Asberg Depression Rating Scale (MADRS) and Young Mania Rating Scale (YMRS). Other outcomes included the WHO-Disability Assessment Schedule II (WHO-DAS II).
Results
Fifteen individuals were enrolled (mean age 68.6, SD 6.12), 53% female, 73% Caucasian, 13% African-American, 7% Asian). There were 4/15 (27%) individuals who prematurely terminated study while 11/15 (73%) completed study. There were significant improvements from baseline on BPRS (P<.05), on CGI overall (P<.01), and on CGI mania (P<.05) and depression (P<.01) sub-scales. Mean dose of asenapine was 11.2 (SD 6.2) mg/day. The most common reported side effects were gastrointestinal discomfort (n=5, 33%), restlessness (n=2, 13%), tremors (n=2, 13%), cognitive difficulties (n=2, 13%), and sluggishness (n=2, 13%).
Conclusions
Elders with BD had global improvements on asenapine. Most reported adverse effects were mild and transient, but adverse effects prompted drug discontinuation in just over one-quarter of patients. While risks vs. benefits in older people must always be carefully considered, asenapine may be a treatment consideration for some non-demented geriatric BD patients.
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