Elsevier

Journal of Affective Disorders

Volume 145, Issue 1, 15 February 2013, Pages 130-132
Journal of Affective Disorders

Brief report
Asenapine for elderly bipolar manic patients

https://doi.org/10.1016/j.jad.2012.05.027Get rights and content

Abstract

Background

Bipolar disorder (BPD) in the elderly is probably heterogeneous and its etiopathogenesis is complex. The data for the treatment of late-life BPD are limited. Asenapine is approved in the United States for acute treatment of manic or mixed episodes of bipolar I disorder with or without psychotic features.

Aim

We report the results of acute treatment with asenapine in elderly patients with BPD.

Method

Elderly patients (N=11), mean age: 67.7±6.1 years, consecutively admitted to the psychogeriatric ward due to acute bipolar mania were treated by asenapine 10 mg/BID monotherapy for 4 weeks. Safety and tolerability assessments included adverse events (AEs), laboratory values, and anthropometric measures. Response, a secondary assessment, was measured as change in Young Mania Rating Scale (YMRS) total score from baseline to week 4.

Results

One patient developed a rash on day 6 of treatment and one patient developed peripheral edema on day 14 of treatment. Both AEs resolved rapidly following discontinuation of asenapine. Only mild sedation was reported by three patients. In all cases, mean (±SD) change (improvement) in YMRS total score at week 4 was −21.4±12.9 and 7/11 (63.6%) of patients remitted (YMRS≤12).

Conclusion

In this small open-label study of elderly patients with bipolar mania, acute treatment with asenapine was well tolerated and effective.

Introduction

Bipolar disorder (BPD) is a chronic mood disorder characterized by episodes of either elevated mood or depression in a sizable number of adults in the community. Though the prevalence rates of BPD in the elderly are lower in community settings (up to 0.1%), there is a significantly higher morbidity in protected environments, such as nursing homes and hospitals, where prevalence rates may be as high as 10% (Tsai et al., 2009). BPD in the elderly is probably heterogeneous and its etiopathogenesis is complex (Oostervink et al., 2009). Treatment of late life BPD is currently based on guidelines drawn up for younger BPD patients (Al Jurdi et al., 2008). Unfortunately, there is a considerable dearth of literature involving evidence-based clinical practice guidelines and randomized controlled trials in elderly individuals with BPD. Available options for the treatment of BPD (including those for mania, hypomania, depression, or maintenance) in the elderly include lithium, antiepileptics, antipsychotics, benzodiazepines, antidepressants, ECT, and psychotherapy (Sajatovic et al., 2005).

To date sparse research has been published focusing on the use of second generation antipsychotics for elderly bipolar patients (Maher et al., 2011). Asenapine is a second generation antipsychotic approved for bipolar disorder and schizophrenia. In one of the pivotal studies of asenapine for treating acute bipolar mania, 488 adults with manic or mixed episodes were randomized to asenapine, olanzapine or placebo. Mean daily dosages were asenapine 18.2 mg and olanzapine 15.8 mg. Compared to placebo, significantly greater changes in the Young Mania Rating Scale (YMRS) (Young et al., 1978) scores were observed as early as day 2 with asenapine and olanzapine and were maintained until day 21. However, there was only one patient older than 65 years in the asenapine arm (McIntyre et al., 2009). Thus, asenapine for elderly manic BPD patients has never been tested in a randomized controlled trial, or in “real-life” clinical settings.

The aim of the present study was to assess tolerability and response to asenapine treatment in elderly BPD patients admitted to a tertiary care psychiatric center with acute mania.

Section snippets

Methods

The Abarbanel Mental Health Center, Bat-Yam, Israel is affiliated with the Sackler School of Medicine, Tel-Aviv University. At this center, there are 300 inpatients beds and 60 day-patients, as well as a large outpatients clinic. The center serves an urban catchment area of approximately 900,000 people, of whom 15.4% are 60 years or older.

Eleven consecutively admitted elderly inpatients suffering from a manic episode since Jan 2012 were included in the study according to the following criteria:

Dosing

Mean daily dose of asenapine was 20 mg. For the first 3 days of treatment asenapine 5 mg BID was initiated and from day 4 to end of study the dose was maintained at 10 mg BID. Asenapine was prescribed as monotherapy in this study and no concomitant psychotropic medications were allowed.

Response

YMRS total score: Mean±SD YMRS total scores at baseline were within the clinically severe stage (33.5±12.7). With LOCF analysis, changes from baseline to day 28 were statistically significantly (−21.4±12.9; p<0.001).

Discussion

Asenapine is approved in the United States for acute treatment of manic or mixed episodes of bipolar I disorder with or without psychotic features. It has also been shown to be well tolerated and long-term maintenance of efficacy is supported (McIntyre et al., 2010). The present study aimed to assess the response to asenapine in treating acute mania in elderly bipolar patients. The results of this open trial indicates that asenapine at a fixed dose of 10 mg BID is effective and well tolerated in

Role of funding source

No sources of funding were provided and thus had no role in the design, execution and interpretation of this study.

Conflicts of interest statements

All authors declare that they have no conflicts of interest.

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