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

Abstract

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 (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.

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.

• Authors: Ashwin Patkar, William Gilmer, Chi-un Pae, Paul A Vöhringer, Michael Ziffra, Edward Pirok, Molly Mulligan, Megan M Filkowski, Elizabeth A Whitham, Niki S Holtzman, Sairah B Thommi, Tanya Logvinenko, Antony Loebel, Prakash Masand, S Nassir Ghaemi
• Journal: PloS one (PLoS One) Vol. 7 Issue 4 Pg. e34757 ( 2012) ISSN: 1932-6203 [Electronic] United States
• PMID: 22545088 (Publication Type: Journal Article, Randomized Controlled Trial, Research Support, N.I.H., Extramural, Research Support, Non-U.S. Gov't)

Chemical References

• Antipsychotic Agents
• Piperazines
• Thiazoles
• ziprasidone

Topics

• Acute Disease
• Adult
• Antipsychotic Agents (adverse effects, therapeutic use)
• Bipolar Disorder (drug therapy)
• Depressive Disorder, Major (drug therapy)
• Double-Blind Method
• Female
• Humans
• Male
• Middle Aged
• Piperazines (adverse effects, therapeutic use)
• Thiazoles (adverse effects, therapeutic use)
• Treatment Outcome