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Lurasidone in the treatment of schizophrenia: a 6-week, placebo-controlled study.
Psychopharmacology (Berl). 2013 Feb; 225(3):519-30.P

Abstract

RATIONALE

There is an unmet need in the treatment of schizophrenia for effective medications with fewer adverse effects.

OBJECTIVE

This study aims to evaluate the efficacy and safety of lurasidone, an atypical antipsychotic, for the treatment of schizophrenia.

METHODS

Patients with an acute exacerbation of schizophrenia were randomized to 6 weeks of double-blind treatment with once-daily, fixed-dose lurasidone 40 mg (N = 50), lurasidone 120 mg (N = 49), or placebo (N = 50). The primary efficacy measure was mean change from baseline to day 42 (last observation carried forward) in the Brief Psychiatric Rating Scale derived (BPRSd) from the Positive and Negative Syndrome Scale (PANSS).

RESULTS

Mean change in BPRSd was significantly greater in patients receiving lurasidone 40 and 120 mg/day versus placebo (-9.4 and -11.0 versus -3.8; p = 0.018 and 0.004, respectively). Treatment with lurasidone 120 mg/day was superior to placebo across all secondary measures, including PANSS total (p = 0.009), PANSS positive (p = 0.005), PANSS negative (p = 0.011), and PANSS general psychopathology (p = 0.023) subscales and Clinical Global Impression of Severity (CGI-S; p = 0.001). Treatment with lurasidone 40 mg/day was superior to placebo on the PANSS positive subscale (p = 0.018) and CGI-S (p = 0.002). The most common adverse events for patients receiving lurasidone were nausea (16.2 versus 4.0 % for placebo) and sedation (16.2 versus 10.0 % for placebo). Minimal changes in weight, cholesterol, triglyceride, and glucose levels were observed.

CONCLUSIONS

In this study, which was limited by a relatively high discontinuation rate, lurasidone provided effective treatment for patients with acute exacerbation of chronic schizophrenia and had minimal effects on weight and metabolic parameters.

Authors+Show Affiliations

Dainippon Sumitomo Pharma Co., Ltd., 6-8, Doshomachi 2-Chome, Chuo-ku, Osaka, Japan. masaaki-ogasa@ds-pharma.co.jpNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

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

Language

eng

PubMed ID

22903391

Citation

Ogasa, Masaaki, et al. "Lurasidone in the Treatment of Schizophrenia: a 6-week, Placebo-controlled Study." Psychopharmacology, vol. 225, no. 3, 2013, pp. 519-30.
Ogasa M, Kimura T, Nakamura M, et al. Lurasidone in the treatment of schizophrenia: a 6-week, placebo-controlled study. Psychopharmacology (Berl). 2013;225(3):519-30.
Ogasa, M., Kimura, T., Nakamura, M., & Guarino, J. (2013). Lurasidone in the treatment of schizophrenia: a 6-week, placebo-controlled study. Psychopharmacology, 225(3), 519-30. https://doi.org/10.1007/s00213-012-2838-2
Ogasa M, et al. Lurasidone in the Treatment of Schizophrenia: a 6-week, Placebo-controlled Study. Psychopharmacology (Berl). 2013;225(3):519-30. PubMed PMID: 22903391.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Lurasidone in the treatment of schizophrenia: a 6-week, placebo-controlled study. AU - Ogasa,Masaaki, AU - Kimura,Tatsuya, AU - Nakamura,Mitsutaka, AU - Guarino,John, Y1 - 2012/08/19/ PY - 2012/05/14/received PY - 2012/07/30/accepted PY - 2012/8/21/entrez PY - 2012/8/21/pubmed PY - 2013/6/26/medline SP - 519 EP - 30 JF - Psychopharmacology JO - Psychopharmacology (Berl) VL - 225 IS - 3 N2 - RATIONALE: There is an unmet need in the treatment of schizophrenia for effective medications with fewer adverse effects. OBJECTIVE: This study aims to evaluate the efficacy and safety of lurasidone, an atypical antipsychotic, for the treatment of schizophrenia. METHODS: Patients with an acute exacerbation of schizophrenia were randomized to 6 weeks of double-blind treatment with once-daily, fixed-dose lurasidone 40 mg (N = 50), lurasidone 120 mg (N = 49), or placebo (N = 50). The primary efficacy measure was mean change from baseline to day 42 (last observation carried forward) in the Brief Psychiatric Rating Scale derived (BPRSd) from the Positive and Negative Syndrome Scale (PANSS). RESULTS: Mean change in BPRSd was significantly greater in patients receiving lurasidone 40 and 120 mg/day versus placebo (-9.4 and -11.0 versus -3.8; p = 0.018 and 0.004, respectively). Treatment with lurasidone 120 mg/day was superior to placebo across all secondary measures, including PANSS total (p = 0.009), PANSS positive (p = 0.005), PANSS negative (p = 0.011), and PANSS general psychopathology (p = 0.023) subscales and Clinical Global Impression of Severity (CGI-S; p = 0.001). Treatment with lurasidone 40 mg/day was superior to placebo on the PANSS positive subscale (p = 0.018) and CGI-S (p = 0.002). The most common adverse events for patients receiving lurasidone were nausea (16.2 versus 4.0 % for placebo) and sedation (16.2 versus 10.0 % for placebo). Minimal changes in weight, cholesterol, triglyceride, and glucose levels were observed. CONCLUSIONS: In this study, which was limited by a relatively high discontinuation rate, lurasidone provided effective treatment for patients with acute exacerbation of chronic schizophrenia and had minimal effects on weight and metabolic parameters. SN - 1432-2072 UR - https://www.unboundmedicine.com/medline/citation/22903391/Lurasidone_in_the_treatment_of_schizophrenia:_a_6_week_placebo_controlled_study_ L2 - https://dx.doi.org/10.1007/s00213-012-2838-2 DB - PRIME DP - Unbound Medicine ER -