A 6 week randomized double-blind placebo-controlled trial of ziprasidone for the acute depressive mixed state.

Journal Article

OBJECTIVE: To examine the efficacy of ziprasidone vs. placebo for the depressive mixed state in patients with bipolar disorder type II or major depressive disorder (MDD). METHODS: 73 patients were randomized in a double-blinded, placebo-controlled study to ziprasidone (40-160 mg/d) or placebo for 6 weeks. They met DSM-IV criteria for a major depressive episode (MDE), while also meeting 2 or 3 (but not more nor less) DSM-IV manic criteria. They did not meet DSM-IV criteria for a mixed or manic episode. Baseline psychotropic drugs were continued unchanged. The primary endpoint measured was Montgomery-Åsberg Depression Rating Scale (MADRS) scores over time. The mean dose of ziprasidone was 129.7±45.3 mg/day and 126.1±47.1 mg/day for placebo. RESULTS: The primary outcome analysis indicated efficacy of ziprasidone versus placebo (pā€Š=ā€Š0.0038). Efficacy was more pronounced in type II bipolar disorder than in MDD (pā€Š=ā€Š0.036). Overall ziprasidone was well tolerated, without notable worsening of weight or extrapyramidal symptoms. CONCLUSIONS: There was a statistically significant benefit with ziprasidone versus placebo in this first RCT of any medication for the provisional diagnostic concept of the depressive mixed state. TRIAL REGISTRATION: Clinicaltrials.gov NCT00490542.

Full Text

Duke Authors

Cited Authors

  • Patkar, A; Gilmer, W; Pae, C-U; Vöhringer, PA; Ziffra, M; Pirok, E; Mulligan, M; Filkowski, MM; Whitham, EA; Holtzman, NS; Thommi, SB; Logvinenko, T; Loebel, A; Masand, P; Ghaemi, SN

Published Date

  • 2012

Published In

Volume / Issue

  • 7 / 4

Start / End Page

  • e34757 -

PubMed ID

  • 22545088

Electronic International Standard Serial Number (EISSN)

  • 1932-6203

Digital Object Identifier (DOI)

  • 10.1371/journal.pone.0034757

Language

  • eng

Conference Location

  • United States