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Four-week, double-blind, placebo- and ziprasidone-controlled trial of iloperidone in patients with acute exacerbations of schizophrenia.
J Clin Psychopharmacol. 2008 Apr; 28(2 Suppl 1):S20-8.JC

Abstract

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.

Authors+Show Affiliations

University of Florida, Gainesville, FL, USA.No affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Clinical Trial, Phase III
Comparative Study
Journal Article
Multicenter Study
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

18334909

Citation

Cutler, Andrew J., et al. "Four-week, Double-blind, Placebo- and Ziprasidone-controlled Trial of Iloperidone in Patients With Acute Exacerbations of Schizophrenia." Journal of Clinical Psychopharmacology, vol. 28, no. 2 Suppl 1, 2008, pp. S20-8.
Cutler AJ, Kalali AH, Weiden PJ, et al. Four-week, double-blind, placebo- and ziprasidone-controlled trial of iloperidone in patients with acute exacerbations of schizophrenia. J Clin Psychopharmacol. 2008;28(2 Suppl 1):S20-8.
Cutler, A. J., Kalali, A. H., Weiden, P. J., Hamilton, J., & Wolfgang, C. D. (2008). Four-week, double-blind, placebo- and ziprasidone-controlled trial of iloperidone in patients with acute exacerbations of schizophrenia. Journal of Clinical Psychopharmacology, 28(2 Suppl 1), S20-8. https://doi.org/10.1097/JCP.0b013e318169d4ce
Cutler AJ, et al. Four-week, Double-blind, Placebo- and Ziprasidone-controlled Trial of Iloperidone in Patients With Acute Exacerbations of Schizophrenia. J Clin Psychopharmacol. 2008;28(2 Suppl 1):S20-8. PubMed PMID: 18334909.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Four-week, double-blind, placebo- and ziprasidone-controlled trial of iloperidone in patients with acute exacerbations of schizophrenia. AU - Cutler,Andrew J, AU - Kalali,Amir H, AU - Weiden,Peter J, AU - Hamilton,Jennifer, AU - Wolfgang,Curt D, PY - 2008/5/6/pubmed PY - 2008/6/27/medline PY - 2008/5/6/entrez SP - S20 EP - 8 JF - Journal of clinical psychopharmacology JO - J Clin Psychopharmacol VL - 28 IS - 2 Suppl 1 N2 - 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. SN - 0271-0749 UR - https://www.unboundmedicine.com/medline/citation/18334909/Four_week_double_blind_placebo__and_ziprasidone_controlled_trial_of_iloperidone_in_patients_with_acute_exacerbations_of_schizophrenia_ DB - PRIME DP - Unbound Medicine ER -