Aripiprazole Therapy in 20 Older Adults With Bipolar Disorder: A 12-Week, Open-Label Trial

Objective: Bipolar disorder in older adult populations has gained increasing attention due to the growing proportion of elderly in the United States and worldwide. A continuing unmet need is the identification of agents that are generally well-tolerated and effective in later life bipolar disorder. Aripiprazole is an atypical antipsychotic compound that is approved by the U.S. Food and Drug Administration for the treatment of bipolar mania and for the long-term treatment of bipolar disorder. This study is an open-label, prospective trial of aripiprazole therapy in 20 older adult patients with bipolar disorder.

Method: Older adults with bipolar I disorder (confirmed by the Mini-International Neuropsychiatric Interview) who were currently suboptimally responsive to their prescribed medication treatments received 12 weeks of open-label aripiprazole added on to existing mood stabilizer medication treatment. Aripiprazole was initiated at 5 mg daily and increased as tolerated. Efficacy outcomes included psychopathology measures (the Young Mania Rating Scale [YMRS] and the Hamilton Rating Scale for Depression [HAM-D]), extrapyramidal symptoms, and a level of functioning measure (the Global Assessment Scale [GAS]). The study was conducted from April 2004 to June 2005.

Results: Twenty older adults (mean age = 59.6 years, range 50-83 years) received aripiprazole therapy. Compared to baseline, individuals had significant reductions in mean depression scores (HAM-D baseline = 13.8, HAM-D end point = 6.1, p < .001), as well as mania scores (YMRS baseline = 8.6, YMRS end point = 3.9, p < .03). There were also significant improvements in functional status as measured by the GAS (p < .001). The mean ± SD daily dose of aripiprazole was 10.26 ± 4.9 mg/day. Overall, aripiprazole was adequately tolerated in this older adult population.

Conclusion: Aripiprazole therapy may reduce symptoms in bipolar older adults, and it appears to be reasonably tolerated. However, larger, controlled trials are needed to confirm these preliminary findings.