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

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Authors: Patkar, A.; Gilmer, W.; Pae, C. U.; Vohringer, P. A.; Ziffra, M.; Pirok, E.; Mulligan, M.; Filkowski, M. M.; Whitham, E. A.; Holtzman, N. S.; Thommi, S. B.; Logvinenko, T.; Loebel, A.; Masand, P.; Ghaemi, S. N.
Article Title: 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-Asberg 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.
Journal Title: PloS one
Volume: 7
Issue: 4
ISSN: 1932-6203; 1932-6203
Publisher: Unknown  
Journal Place: United States
Date Published: 2012
Start Page: e34757
Language: eng
DOI/URL:

10.1371/journal.pone.0034757

10.1371/journal.pone.0034757
Notes: LR: 20131106; ClinicalTrials.gov/NCT00490542; GR: UL1 RR025752/RR/NCRR NIH HHS/United States; JID: 101285081; 0 (Antipsychotic Agents); 0 (Piperazines); 0 (Thiazoles); 6UKA5VEJ6X (ziprasidone); OID: NLM: PMC3335844; 2011/07/29 [received]; 2012/03/05 [accepted]; 2012/04/24 [epublish]; ppublish