Background: The use of atypical neuroleptics for bipolar depression is currently being studied extensively. Given ziprasidone's favorable side effect profile as compared to other atypical neuroleptics, and the dearth of studies of this drug in depressed bipolar patients, we initiated an 8 week open monotherapy trial in bipolar II patients suffering major depressive episodes.
Method: Patients met DSM IV criteria for bipolar II disorder, were in a major depressive episode, and had a 17 item HAM-D score of 18 or greater. Ziprasidone was begun at 20 mg bid and raised step wise to 60 mg bid if needed and tolerated. Change was assessed on the HAM-D (primary outcome measure), HAM-A, MADRS, YMRS, CGI-S, CGI-I, BDI and Q-LES-Q scales. Safety and tolerability were assessed. The study was approved by Asentral IRB and all patients gave written informed consent.
Results: Thirty patients (including 6 early terminators) completed the study. Significant improvement was seen at all visits on HAM-D, CGI-S and BDI (beginning week 1), and on MADRS and HAM-A (beginning week 2). Nine patients (30%) were responders and 5 (17%) remitters at week 1; 18 (60%) were responders and 13 (43%) remitters by the end of treatment. There was one serious AE's that was not study drug related, and no patient became manic. Occasional mild hypomania responded to dosage reduction. Mean end of study dose was 58 mg/day.
Limitations: Given the small sample size and lack of placebo control, the results must be considered preliminary.
Conclusions: Ziprasidone at a relatively low dose appears to be a rapid, effective and generally well tolerated treatment for bipolar II patients experiencing major depression. However, larger, placebo-controlled trials are needed to confirm these findings.