Introduction
The Atypical Anti-psychotics (AAP) are being used increasingly for the treatment of Bipolar Disorder. Most evidence available for their use stems from monotherapy studies, but their clinical application, in the main, has been as an add-on medication or in combination with the more traditional mood stabilisers. This is because the majority of Bipolar patients respond inadequately to monotherapy alone. This paper will review available evidence for AAP's as either augmentation or combination drugs in Bipolar Disorder. The paper will also present data from a small study performed at The Melbourne Clinic where aripiprazole was studied as an add-on agent in Bipolar patients. Aripiprazole is an AAP with a unique mode of action, being a dopamine partial agonist.
Method
In this 8 week open study assessed efficacy of aripiprazole when added to a stable dose of medication in BPI or BPII. Patients were taking a mood stabiliser and/or a antidepressant and were experiencing clinically significant symptoms. 20 patients entered the study: 10 males and mean age 48 ± 12 years. 14 subjects were BP II and 6 BP I. Mean (±SD) baseline scores were: MADRS 20.5 ± 7.8, YMRS 7.5 ± 6.5, CGI-S 4.2 ± 0.7.
Results
There was a significant decrease in MADRS scores from baseline to week 8 (p=0.004, paired t-test, LOCF) and in CGI-S scores from baseline to week 8 (p=0.000, LOCF) but not in YRMS scores. Significant differences were apparent at weeks 2 and 4 also for MADRS and CGI-S scores. Observed case analysis resulted in similar significant findings. CGI-I analysis of those who completed 8 weeks found that 71% of subjects were improved.
Conclusions
Aripiprazole was shown to be an effective add-on therapy for depressive symptoms in BP I & II disorder in this open study.