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-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.
  
  
  BACKGROUND
  Clinicaltrials.gov NCT00490542.
authors.affiliation: Department of Psychiatry, Duke University Medical Center, Durham, North Carolina, United States of America.
authors.forename: Ashwin
authors.initials: A
authors.lastname: Patkar
authors.forename: William
authors.initials: W
authors.lastname: Gilmer
authors.forename: Chi-un
authors.initials: CU
authors.lastname: Pae
authors.forename: Paul A
authors.initials: PA
authors.lastname: Vöhringer
authors.forename: Michael
authors.initials: M
authors.lastname: Ziffra
authors.forename: Edward
authors.initials: E
authors.lastname: Pirok
authors.forename: Molly
authors.initials: M
authors.lastname: Mulligan
authors.forename: Megan M
authors.initials: MM
authors.lastname: Filkowski
authors.forename: Elizabeth A
authors.initials: EA
authors.lastname: Whitham
authors.forename: Niki S
authors.initials: NS
authors.lastname: Holtzman
authors.forename: Sairah B
authors.initials: SB
authors.lastname: Thommi
authors.forename: Tanya
authors.initials: T
authors.lastname: Logvinenko
authors.forename: Antony
authors.initials: A
authors.lastname: Loebel
authors.forename: Prakash
authors.initials: P
authors.lastname: Masand
authors.forename: S Nassir
authors.initials: SN
authors.lastname: Ghaemi
mesh_terms: D000208:Acute Disease; D000328:Adult; D014150:Antipsychotic Agents / Q000009:adverse effects / Q000627:therapeutic use*; D001714:Bipolar Disorder / Q000188:drug therapy*; D003865:Major Depressive Disorder / Q000188:drug therapy*; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D010879:Piperazines / Q000009:adverse effects / Q000627:therapeutic use*; D013844:Thiazoles / Q000009:adverse effects / Q000627:therapeutic use*; D016896:Treatment Outcome
chemical_list: D014150:Antipsychotic Agents; D010879:Piperazines; D013844:Thiazoles; C092292:ziprasidone