PMID- 22395527
OWN - NLM
STAT- MEDLINE
DCOM- 20120724
LR  - 20220316
IS  - 1473-5857 (Electronic)
IS  - 0268-1315 (Linking)
VI  - 27
IP  - 3
DP  - 2012 May
TI  - Long-term safety and tolerability of lurasidone in schizophrenia: a 12-month, 
      double-blind, active-controlled study.
PG  - 165-76
LID - 10.1097/YIC.0b013e32835281ef [doi]
AB  - The aim of this study is to evaluate the long-term safety and tolerability of 
      lurasidone in the treatment of schizophrenia. Clinically stable adult outpatients 
      with schizophrenia were randomized in a 2 : 1 ratio to 12 months of double-blind 
      treatment with once-daily, flexibly-dosed lurasidone (40-120 mg) or risperidone 
      (2-6 mg). Outcome measures included adverse events (AEs), vital signs, ECG, and 
      laboratory tests. Secondary assessments included measures of psychopathology. A 
      total of 427 patients were randomized to treatment with lurasidone and 202 with 
      risperidone. The three most frequent AEs in the lurasidone group (vs. 
      risperidone) were nausea (16.7 vs. 10.9%), insomnia (15.8 vs. 13.4%), and 
      sedation (14.6 vs. 13.9%); the three most frequent AEs in the risperidone group 
      (vs. lurasidone) were increased weight (19.8 vs. 9.3%), somnolence (17.8 vs. 
      13.6%), and headache (14.9 vs. 10.0%). A higher proportion of patients receiving 
      risperidone had at least a 7% endpoint increase in weight (14 vs. 7%). The median 
      endpoint change in prolactin was significantly higher for risperidone (P<0.001). 
      A comparable improvement in efficacy measures was observed with both agents and 
      the rates of relapse were similar. All-cause discontinuation rates were higher 
      for lurasidone versus risperidone. Long-term treatment with lurasidone was 
      generally well tolerated in this study, with minimal effects on weight and 
      metabolic outcomes.
FAU - Citrome, Leslie
AU  - Citrome L
AD  - Department of Psychiatry & Behavioral Sciences, New York Medical College, 
      Valhalla, New York, USA. nntman@gmail.com
FAU - Cucchiaro, Josephine
AU  - Cucchiaro J
FAU - Sarma, Kaushik
AU  - Sarma K
FAU - Phillips, Debra
AU  - Phillips D
FAU - Silva, Robert
AU  - Silva R
FAU - Tsuchiya, Satoru
AU  - Tsuchiya S
FAU - Loebel, Antony
AU  - Loebel A
LA  - eng
SI  - ClinicalTrials.gov/NCT00641745
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
PL  - England
TA  - Int Clin Psychopharmacol
JT  - International clinical psychopharmacology
JID - 8609061
RN  - 0 (Antipsychotic Agents)
RN  - 0 (Isoindoles)
RN  - 0 (Thiazoles)
RN  - L6UH7ZF8HC (Risperidone)
RN  - O0P4I5851I (Lurasidone Hydrochloride)
SB  - IM
MH  - Adult
MH  - Ambulatory Care
MH  - Analysis of Variance
MH  - Antipsychotic Agents/adverse effects/*therapeutic use
MH  - Croatia
MH  - Double-Blind Method
MH  - Female
MH  - Humans
MH  - Isoindoles/adverse effects/*therapeutic use
MH  - Israel
MH  - Kaplan-Meier Estimate
MH  - Lurasidone Hydrochloride
MH  - Male
MH  - Middle Aged
MH  - Proportional Hazards Models
MH  - Psychiatric Status Rating Scales
MH  - Risperidone/therapeutic use
MH  - Schizophrenia/diagnosis/*drug therapy
MH  - Schizophrenic Psychology
MH  - South Africa
MH  - South America
MH  - Thailand
MH  - Thiazoles/adverse effects/*therapeutic use
MH  - Time Factors
MH  - Treatment Outcome
MH  - United States
EDAT- 2012/03/08 06:00
MHDA- 2012/07/25 06:00
CRDT- 2012/03/08 06:00
PHST- 2012/03/08 06:00 [entrez]
PHST- 2012/03/08 06:00 [pubmed]
PHST- 2012/07/25 06:00 [medline]
AID - 10.1097/YIC.0b013e32835281ef [doi]
PST - ppublish
SO  - Int Clin Psychopharmacol. 2012 May;27(3):165-76. doi: 
      10.1097/YIC.0b013e32835281ef.