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| Content Provider | World Health Organization (WHO)-Global Index Medicus |
|---|---|
| Author | Meltzer, Herbert Y. Cucchiaro, Josephine Silva, Robert Ogasa, Masaaki Phillips, Debra Xu, Jane Kalali, Amir H. Schweizer, Edward Pikalov, Andrei Loebel, Antony |
| Description | Country affiliation: United States Author Affiliation: Meltzer HY ( Department of Psychiatry, Vanderbilt University School of Medicine, Nashville, Tenn., USA. herbert.meltzer@vanderbilt.edu) |
| Abstract | OBJECTIVE: The study was designed to evaluate the short-term efficacy and safety of lurasidone in the treatment of acute schizophrenia. METHOD: Participants, who were recently admitted inpatients with schizophrenia with an acute exacerbation of psychotic symptoms, were randomly assigned to 6 weeks of double-blind treatment with 40 mg of lurasidone, 120 mg of lurasidone, 15 mg of olanzapine (included to test for assay sensitivity), or placebo, dosed once daily. Efficacy was evaluated using a mixed-model repeated-measures analysis of the change from baseline to week 6 in Positive and Negative Syndrome Scale (PANSS) total score (as the primary efficacy measure) and Clinical Global Impressions severity (CGI-S) score (as the key secondary efficacy measure). RESULTS: Treatment with both doses of lurasidone or with olanzapine was associated with significantly greater improvement at week 6 on PANSS total score, PANSS positive and negative subscale scores, and CGI-S score compared with placebo. There was no statistically significant difference in mean PANSS total or CGI-S change scores for the lurasidone groups compared with the olanzapine group. With responders defined as those with an improvement of at least 20% on the PANSS, endpoint responder rates were significant compared with placebo for olanzapine only. The incidence of akathisia was higher with 120 mg of lurasidone (22.9%) than with 40 mg of lurasidone (11.8%), olanzapine (7.4%), or placebo (0.9%). The proportion of patients experiencing ≥ 7% weight gain was 5.9% for the lurasidone groups combined, 34.4% for the olanzapine group, and 7.0% for the placebo group. CONCLUSIONS: Lurasidone was an effective treatment for patients with acute schizophrenia. Safety assessments indicated a higher frequency of adverse events associated with 120 mg/day of lurasidone compared with 40 mg/day. |
| File Format | HTM / HTML |
| ISSN | 0002953X |
| e-ISSN | 15357228 |
| Journal | American Journal of Psychiatry |
| Issue Number | 9 |
| Volume Number | 168 |
| Language | English |
| Publisher | American Psychiatric Association |
| Publisher Date | 2011-09-01 |
| Publisher Place | United States |
| Access Restriction | Open |
| Subject Keyword | Discipline Psychiatry Antipsychotic Agents Therapeutic Use Benzodiazepines Isoindoles Schizophrenia Drug Therapy Thiazoles Acute Disease Dose-response Relationship, Drug Double-blind Method Adverse Effects Lurasidone Hydrochloride Patient Admission Psychiatric Status Rating Scales Comparative Study Multicenter Study Randomized Controlled Trial |
| Content Type | Text |
| Resource Type | Article |
| Subject | Psychiatry and Mental Health |
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