Ziprasidone plus a mood stabilizer in subjects with bipolar i disorder

A 6-month, randomized, placebo-controlled, double-blind trial

Charles L. Bowden, Eduard Vieta, Kathleen S. Ice, Jeffrey H. Schwartz, Paul P. Wang, Mark Versavel

Research output: Contribution to journalArticle

99 Citations (Scopus)

Abstract

Objective: To evaluate the efficacy and safety of ziprasidone adjunctive to a mood stabilizer for the maintenance treatment of bipolar mania. Method: Subjects with DSM-IV bipolar I disorder with a Mania Rating Scale score ≥ 14 were enrolled. Subjects achieving ≥ 8 consecutive weeks of stability with open-label ziprasidone (80-160mg/d) and lithium or valproate (period 1) were randomly assigned in the 6-month, double-blind maintenance period (period 2) to ziprasidone plus mood stabilizer or placebo plus 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). The study was conducted from December 2005 to May 2008. Results: A total of 127 and 113 subjects were randomly assigned to ziprasidone and placebo, respectively. Intervention for a mood episode was required in 19.7% and 32.4% of ziprasidone and placebo subjects, respectively. The time to intervention for a mood episode was significantly longer for ziprasidone than placebo (P = .0104). The median time to intervention for a mood episode among those requiring such an intervention (n = 61) was 43.0 days for ziprasidone versus 26.5 days for placebo. The time to discontinuation for any reason was significantly longer for ziprasidone (P = .0047). Adjunctive ziprasidone treatment was well tolerated. Among treatment-emergent adverse events occurring in ≥5% of subjects in either treatment group during period 2, only tremor occurred more frequently in the ziprasidone versus placebo group (6.3% vs 3.6%). Conclusions: Ziprasidone is an effective, safe, and well-tolerated adjunctive treatment with a mood stabilizer for long-term maintenance treatment of bipolar mania. Trial Registration: clinicaltrials.gov Identifier: NCT00280566.

Original languageEnglish (US)
Pages (from-to)130-137
Number of pages8
JournalJournal of Clinical Psychiatry
Volume71
Issue number2
DOIs
StatePublished - Feb 2010

Fingerprint

Bipolar Disorder
Placebos
ziprasidone
Therapeutics
Valproic Acid
Tremor
Lithium
Diagnostic and Statistical Manual of Mental Disorders
Maintenance
Safety

ASJC Scopus subject areas

  • Psychiatry and Mental health

Cite this

Ziprasidone plus a mood stabilizer in subjects with bipolar i disorder : A 6-month, randomized, placebo-controlled, double-blind trial. / Bowden, Charles L.; Vieta, Eduard; Ice, Kathleen S.; Schwartz, Jeffrey H.; Wang, Paul P.; Versavel, Mark.

In: Journal of Clinical Psychiatry, Vol. 71, No. 2, 02.2010, p. 130-137.

Research output: Contribution to journalArticle

Bowden, Charles L. ; Vieta, Eduard ; Ice, Kathleen S. ; Schwartz, Jeffrey H. ; Wang, Paul P. ; Versavel, Mark. / Ziprasidone plus a mood stabilizer in subjects with bipolar i disorder : A 6-month, randomized, placebo-controlled, double-blind trial. In: Journal of Clinical Psychiatry. 2010 ; Vol. 71, No. 2. pp. 130-137.
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