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A 6-month, Randomized, Placebo-controlled, Double Blind Trial of Ziprasidone Plus a Mood Stabilizer in Subjects With Bipolar I Disorder

Published online by Cambridge University Press:  16 April 2020

E. Vieta ,
C. Bowden ,
K. Ice ,
O. Gurtovaya ,
J. Schwartz  and
P. Wang
E. Vieta
Affiliation:
Clinical Institute of Neuroscience Hospital Clinic, University of Barcelona, IDIBAPS, CIBERSAM, Barcelona, Spain
C. Bowden
Affiliation:
Department of Psychiatry, University of Texas Health Sciences Center, San Antonio, New London, USA
K. Ice
Affiliation:
Pfizer Global Research and Development, New London, USA
O. Gurtovaya
Affiliation:
Pfizer Global Research and Development, New London, USA
J. Schwartz
Affiliation:
Pfizer Global Research and Development, New London, USA
P. Wang
Affiliation:
Pfizer Global Research and Development, New London, USA

Abstract

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Background:

The objective of this study was to evaluate the efficacy and safety of ziprasidone adjunctive to a mood stabilizer for the maintenance treatment of bipolar mania.

Methods:

Male and female subjects with bipolar I disorder with MRS 3 14 were enrolled. Subjects achieving ≥ 8 consecutive weeks of stability with open-label ziprasidone (80-160 mg/d) and lithium or divalproex were randomized into the 6-month double-blind maintenance period, to ziprasidone + mood stabilizer or placebo + mood stabilizer. The primary and key secondary end points were the time to intervention for a mood episode, and time to discontinuation for any reason, respectively. Inferential analysis was performed using a Kaplan-Meier product-limit estimator (Log-rank test).

Results:

127 and 112 subjects were randomized to and treated in the ziprasidone and placebo groups, respectively. The time to intervention for a mood episode was significantly different, favoring ziprasidone (p = 0.0104). 19.7% and 32.4% of ziprasidone and placebo subjects, respectively, required intervention for a mood episode. Time to discontinuation for any reason was significantly different (p = 0.0047), favoring ziprasidone. Among treatment-emergent adverse events occurring in the double-blind period, the only event occurring more frequently in the ziprasidone group than in the placebo group (≥ 5%) was tremor (6.3% vs 3.6%, respectively).

Conclusions:

These results demonstrate that ziprasidone is an effective, safe, and well-tolerated adjunctive treatment with a mood stabilizer for long-term maintenance treatment of bipolar mania.

Type
P01-206
Information
European Psychiatry , Volume 24 , Issue S1: 17th EPA Congress - Lisbon, Portugal, January 2009, Abstract book , January 2009 , 24-E594
Copyright
Copyright © European Psychiatric Association 2009
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