PMID- 18334909
OWN - NLM
STAT- MEDLINE
DCOM- 20080626
LR  - 20220310
IS  - 0271-0749 (Print)
IS  - 0271-0749 (Linking)
VI  - 28
IP  - 2 Suppl 1
DP  - 2008 Apr
TI  - Four-week, double-blind, placebo- and ziprasidone-controlled trial of iloperidone 
      in patients with acute exacerbations of schizophrenia.
PG  - S20-8
LID - 10.1097/JCP.0b013e318169d4ce [doi]
AB  - Iloperidone is a mixed D2/5-HT2 antagonist in development for treatment of 
      schizophrenia. This trial aimed to evaluate the efficacy and safety of a fixed 
      dose of iloperidone in patients with acute exacerbations of schizophrenia. This 
      randomized, placebo-controlled, multicenter study comprised a 1-week titration 
      period and a 3-week double-blind maintenance period. Eligible patients (n = 593) 
      were randomized to iloperidone 24 mg/d, ziprasidone 160 mg/d as an active 
      control, or placebo. Primary efficacy variable was change from baseline in the 
      Positive and Negative Syndrome Scale Total (PANSS-T) score, using a mixed-effects 
      model repeated measures analysis. Iloperidone demonstrated significant reduction 
      versus placebo on the PANSS-T score (P< 0.01). Significant improvement versus 
      placebo was also demonstrated with ziprasidone (P < 0.05). Compared with 
      ziprasidone, iloperidone was associated with lower rates of many adverse events 
      (AEs) that are particularly troublesome with antipsychotics, including sedation, 
      somnolence, extrapyramidal symptoms, akathisia, agitation, and restlessness; 
      iloperidone was associated with higher rates of weight gain, tachycardia, 
      orthostatic hypotension, dizziness, and nasal congestion as reported as an AE. 
      Most AEs were mild to moderate. A similar amount of QT prolongation was observed 
      with both active treatments, although no patient had a treatment-emergent 
      postbaseline corrected QT interval of 500 msec or greater. The incidence of 
      clinically relevant changes in laboratory parameters was comparable between 
      iloperidone and ziprasidone. Iloperidone was associated with a low incidence of 
      extrapyramidal symptoms. Overall, there was improvement in akathisia with 
      iloperidone treatment. Iloperidone treatment was effective, safe, and well 
      tolerated in patients with acute exacerbation of schizophrenia.
FAU - Cutler, Andrew J
AU  - Cutler AJ
AD  - University of Florida, Gainesville, FL, USA.
FAU - Kalali, Amir H
AU  - Kalali AH
FAU - Weiden, Peter J
AU  - Weiden PJ
FAU - Hamilton, Jennifer
AU  - Hamilton J
FAU - Wolfgang, Curt D
AU  - Wolfgang CD
LA  - eng
PT  - Clinical Trial, Phase III
PT  - Comparative Study
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
PL  - United States
TA  - J Clin Psychopharmacol
JT  - Journal of clinical psychopharmacology
JID - 8109496
RN  - 0 (Antipsychotic Agents)
RN  - 0 (Isoxazoles)
RN  - 0 (Piperazines)
RN  - 0 (Piperidines)
RN  - 0 (Thiazoles)
RN  - 6UKA5VEJ6X (ziprasidone)
RN  - VPO7KJ050N (iloperidone)
SB  - IM
MH  - Acute Disease
MH  - Adolescent
MH  - Adult
MH  - Aged
MH  - Antipsychotic Agents/administration & dosage/adverse effects/*therapeutic use
MH  - Double-Blind Method
MH  - Drug Administration Schedule
MH  - Female
MH  - Humans
MH  - Isoxazoles/administration & dosage/adverse effects/*therapeutic use
MH  - Male
MH  - Middle Aged
MH  - Piperazines/administration & dosage/adverse effects/*therapeutic use
MH  - Piperidines/administration & dosage/adverse effects/*therapeutic use
MH  - Prospective Studies
MH  - Schizophrenia/*drug therapy
MH  - Thiazoles/administration & dosage/adverse effects/*therapeutic use
MH  - Treatment Outcome
EDAT- 2008/05/06 09:00
MHDA- 2008/06/27 09:00
CRDT- 2008/05/06 09:00
PHST- 2008/05/06 09:00 [pubmed]
PHST- 2008/06/27 09:00 [medline]
PHST- 2008/05/06 09:00 [entrez]
AID - 10.1097/JCP.0b013e318169d4ce [doi]
PST - ppublish
SO  - J Clin Psychopharmacol. 2008 Apr;28(2 Suppl 1):S20-8. doi: 
      10.1097/JCP.0b013e318169d4ce.