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Lurasidone in the treatment of acute schizophrenia: a double-blind, placebo-controlled trial.

Abstract

OBJECTIVE

Lurasidone is a novel psychotropic agent with high affinity for D(2) and 5-HT(2A) receptors, as well as for receptors implicated in the enhancement of cognition and mood and the reduction of negative symptoms (5-HT(7), 5-HT(1A), and alpha(2c)). The objective of the study was to evaluate the safety and efficacy of lurasidone in patients hospitalized for an acute exacerbation of DSM-IV-defined schizophrenia.

METHOD

Patients were randomly assigned to 6 weeks of double-blind treatment with a fixed dose of lurasidone 80 mg (N = 90, 75.6% male, mean age = 39.7 years, mean baseline score on the Brief Psychiatric Rating Scale derived from the Positive and Negative Syndrome Scale [BPRSd] = 55.1) or placebo (N = 90, 77.8% male, mean age = 41.9 years, mean BPRSd score = 56.1). The primary efficacy measure was the BPRSd. The study was conducted from May to December 2004.

RESULTS

At day 42, last-observation-carried-forward endpoint, treatment with lurasidone was associated with significant improvement compared to placebo on the BPRSd (least squares mean +/- SE = -8.9 +/- 1.3 vs. -4.2 +/- 1.4; p = .012), as well as on all secondary efficacy measures, including the PANSS total score (-14.1 +/- 2.1 vs. -5.5 +/- 2.2; p = .004) and the PANSS positive (-4.3 +/- 0.7 vs. -1.7 +/- 0.7; p = .006), negative (-2.9 +/- 0.5 vs. -1.3 +/- 0.5; p = .025), and general psychopathology (-7.0 +/- 1.1 vs. -2.7 +/- 1.2; p = .0061) subscales. Significant improvement was seen as early as day 3, based on BPRSd, PANSS, and Clinical Global Impressions-Severity of Illness assessments. Treatment with lurasidone was generally well tolerated and was not associated with adverse changes in metabolic or electrocardiogram parameters. There were no clinically significant differences between lurasidone and placebo in objective measures of extrapyramidal symptoms.

CONCLUSIONS

The results of this study suggest that the novel psychotropic agent lurasidone is a safe and effective treatment for patients with an acute exacerbation of schizophrenia.

TRIAL REGISTRATION

(ClinicalTrials.gov) Identifier: NCT00088634.

Links

  • Publisher Full Text
  • Authors+Show Affiliations

    ,

    Dainippon Sumitomo Pharma America Inc, Fort Lee, NJ 07024, USA.

    , , , , ,

    Source

    The Journal of clinical psychiatry 70:6 2009 Jun pg 829-36

    MeSH

    Acute Disease
    Adult
    Antipsychotic Agents
    Brief Psychiatric Rating Scale
    Double-Blind Method
    Female
    Humans
    Isoindoles
    Lurasidone Hydrochloride
    Male
    Middle Aged
    Psychometrics
    Schizophrenia
    Schizophrenic Psychology
    Thiazoles
    Treatment Outcome
    Young Adult

    Pub Type(s)

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

    Language

    eng

    PubMed ID

    19497249

    Citation

    Nakamura, Mitsutaka, et al. "Lurasidone in the Treatment of Acute Schizophrenia: a Double-blind, Placebo-controlled Trial." The Journal of Clinical Psychiatry, vol. 70, no. 6, 2009, pp. 829-36.
    Nakamura M, Ogasa M, Guarino J, et al. Lurasidone in the treatment of acute schizophrenia: a double-blind, placebo-controlled trial. J Clin Psychiatry. 2009;70(6):829-36.
    Nakamura, M., Ogasa, M., Guarino, J., Phillips, D., Severs, J., Cucchiaro, J., & Loebel, A. (2009). Lurasidone in the treatment of acute schizophrenia: a double-blind, placebo-controlled trial. The Journal of Clinical Psychiatry, 70(6), pp. 829-36. doi:10.4088/JCP.08m04905.
    Nakamura M, et al. Lurasidone in the Treatment of Acute Schizophrenia: a Double-blind, Placebo-controlled Trial. J Clin Psychiatry. 2009;70(6):829-36. PubMed PMID: 19497249.
    * Article titles in AMA citation format should be in sentence-case
    TY - JOUR T1 - Lurasidone in the treatment of acute schizophrenia: a double-blind, placebo-controlled trial. AU - Nakamura,Mitsutaka, AU - Ogasa,Masaaki, AU - Guarino,John, AU - Phillips,Debra, AU - Severs,Joseph, AU - Cucchiaro,Josephine, AU - Loebel,Antony, Y1 - 2009/06/02/ PY - 2008/11/27/received PY - 2009/03/23/accepted PY - 2009/6/6/entrez PY - 2009/6/6/pubmed PY - 2009/7/21/medline SP - 829 EP - 36 JF - The Journal of clinical psychiatry JO - J Clin Psychiatry VL - 70 IS - 6 N2 - OBJECTIVE: Lurasidone is a novel psychotropic agent with high affinity for D(2) and 5-HT(2A) receptors, as well as for receptors implicated in the enhancement of cognition and mood and the reduction of negative symptoms (5-HT(7), 5-HT(1A), and alpha(2c)). The objective of the study was to evaluate the safety and efficacy of lurasidone in patients hospitalized for an acute exacerbation of DSM-IV-defined schizophrenia. METHOD: Patients were randomly assigned to 6 weeks of double-blind treatment with a fixed dose of lurasidone 80 mg (N = 90, 75.6% male, mean age = 39.7 years, mean baseline score on the Brief Psychiatric Rating Scale derived from the Positive and Negative Syndrome Scale [BPRSd] = 55.1) or placebo (N = 90, 77.8% male, mean age = 41.9 years, mean BPRSd score = 56.1). The primary efficacy measure was the BPRSd. The study was conducted from May to December 2004. RESULTS: At day 42, last-observation-carried-forward endpoint, treatment with lurasidone was associated with significant improvement compared to placebo on the BPRSd (least squares mean +/- SE = -8.9 +/- 1.3 vs. -4.2 +/- 1.4; p = .012), as well as on all secondary efficacy measures, including the PANSS total score (-14.1 +/- 2.1 vs. -5.5 +/- 2.2; p = .004) and the PANSS positive (-4.3 +/- 0.7 vs. -1.7 +/- 0.7; p = .006), negative (-2.9 +/- 0.5 vs. -1.3 +/- 0.5; p = .025), and general psychopathology (-7.0 +/- 1.1 vs. -2.7 +/- 1.2; p = .0061) subscales. Significant improvement was seen as early as day 3, based on BPRSd, PANSS, and Clinical Global Impressions-Severity of Illness assessments. Treatment with lurasidone was generally well tolerated and was not associated with adverse changes in metabolic or electrocardiogram parameters. There were no clinically significant differences between lurasidone and placebo in objective measures of extrapyramidal symptoms. CONCLUSIONS: The results of this study suggest that the novel psychotropic agent lurasidone is a safe and effective treatment for patients with an acute exacerbation of schizophrenia. TRIAL REGISTRATION: (ClinicalTrials.gov) Identifier: NCT00088634. SN - 1555-2101 UR - https://www.unboundmedicine.com/medline/citation/19497249/Lurasidone_in_the_treatment_of_acute_schizophrenia:_a_double_blind_placebo_controlled_trial_ L2 - http://www.psychiatrist.com/jcp/article/pages/2009/v70n06/v70n0606.aspx DB - PRIME DP - Unbound Medicine ER -