Lurasidone in the treatment of schizophrenia: a 6-week, placebo-controlled study.
BACKGROUND
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.
Dainippon Sumitomo Pharma Co., Ltd., 6-8, Doshomachi 2-Chome, Chuo-ku, Osaka, Japan. masaaki-ogasa@ds-pharma.co.jp
Masaaki
M
Ogasa
Tatsuya
T
Kimura
Mitsutaka
M
Nakamura
John
J
Guarino
D000293:Adolescent; D000328:Adult; D000704:Analysis of Variance; D014150:Antipsychotic Agents / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D010054:Brief Psychiatric Rating Scale; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D054833:Isoindoles / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D000069056:Lurasidone Hydrochloride; D008297:Male; D008875:Middle Aged; D012559:Schizophrenia / Q000188:drug therapy*; D012565:Schizophrenic Psychology; D016037:Single-Blind Method; D013844:Thiazoles / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D055815:Young Adult
D014150:Antipsychotic Agents; D054833:Isoindoles; D013844:Thiazoles; D000069056:Lurasidone Hydrochloride