A 6 Week Randomized Double-Blind Placebo-Controlled Trial of Ziprasidone for the Acute Depressive Mixed State

作者：Patkar Ashwin^*; Gilmer William; Pae Chi un; Voehringer Paul A; Ziffra Michael; Pirok Edward; Mulligan Molly; Filkowski Megan M; Whitham Elizabeth A; Holtzman Niki S; Thommi Sairah B; Logvinenko Tanya; Loebel Antony; Masand Prakash; Ghaemi S Nassir

来源：PLos One, 2012, 7(4): e34757.

DOI：10.1371/journal.pone.0034757

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). %26lt;br%26gt;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-A sberg 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. %26lt;br%26gt;Results: The primary outcome analysis indicated efficacy of ziprasidone versus placebo (p = 0.0038). Efficacy was more pronounced in type II bipolar disorder than in MDD (p = 0.036). Overall ziprasidone was well tolerated, without notable worsening of weight or extrapyramidal symptoms. %26lt;br%26gt;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.

• 出版日期2012-4-24
• 单位西北大学