Long-Term Safety and Efficacy of Ziprasidone in Subpopulations of Patients With Bipolar Mania
J Clin Psychiatry 2009;70(6):844-851
© Copyright 2015 Physicians Postgraduate Press, Inc.
Purchase This PDF for $40.00
If you are not a paid subscriber, you may purchase the PDF.
(You'll need the free Adobe Acrobat Reader.)
Receive immediate full-text access to JCP. You can subscribe to JCP online-only ($86) or print + online ($156 individual).
With your subscription, receive a free PDF collection of the NCDEU Festschrift articles. Hurry! This offer ends December 31, 2011.
If you are a paid subscriber to JCP and do not yet have a username and password, activate your subscription now.
As a paid subscriber who has activated your subscription, you have access to the HTML and PDF versions of this item.
Click here to login.
Did you forget your password?
Still can't log in? Contact the Circulation Department at 1-800-489-1001 x4 or send email
Objective: To evaluate long-term safety and efficacy of ziprasidone.
Method: Subjects completing a 21-day placebo-controlled trial of ziprasidone in DSM-IV acute bipolar mania (N = 65) were enrolled in a 52-week open-label extension of flexibly dosed ziprasidone 40 to 160 mg/day, administered b.i.d. Three subjects had missing evaluations (N = 62) but still provided demographic data. Subpopulations with manic (N = 43) or mixed (N =19) episodes, and with (N = 37) or without (N = 25) psychotic symptoms, were identified. Safety evaluations included adverse event monitoring, electrocardiography, and standard laboratory assessments. Efficacy measures included change from initial study baseline in Mania Rating Scale (MRS) and Clinical Global Impressions-Severity of Illness scale (CGI-S) scores, as well as MRS responder rates (50% reduction from initial study baseline). The study was conducted from March 1998 to September 1999.
Results: Almost all adverse events (98%) were mild to moderate in severity. The mean±
SD reduction in MRS score at week 55 (last observation carried forward [LOCF]) was 23.5 ± 1.5 (p
Conclusion: Sustained and comparable improvements in symptoms were seen with up to 55 weeks of ziprasidone treatment for patients initially treated for bipolar mania, regardless of whether the baseline episode was manic or mixed or involved psychotic symptoms.