Lurasidone HCl is a compound being developed for the treatment of schizophrenia. This clinical study is designed to test the hypothesis that lurasidone is effective, tolerable, and safe as compared with quetiapine XR long term among schizophrenic outpatients with chronic schizophrenia.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
240
Lurasidone 40-160 mg/day flexibly dosed.
Quetiapine XR 200-800 mg/day flexibly dosed.
Relapse of Psychotic Symptoms
Time to relapse will be defined as the earliest occurrence of any of the following: * Worsening of \>= 30% positive and negative syndrome scale total score from NCT00790192 and clinical global impression-severity sub-scale \>=3 * rehospitalization for worsening of psychosis * emergence of suicidal ideation, homicidal ideation and/or risk of harm to self or others Comparison of time to relapse of psychotic symptoms between lurasidone and quetiapine XR after 1 year as analyzed using the Cox proportional hazard model with country as a covariate.
Time frame: 12 Months
Change From the Acute Phase Baseline to Month 6 of the Double-blind Treatment in the CogState Computerized Cognitive Scores.
The battery has seven outcome measures that measure the cognitive constructs. The seven domains are: detection, identification, one back task, international shopping list task, one card learning task, Groton maze learning task and social emotional matching. The standardized scores for each subject at each assessment will then be averaged to yield a composite score. There are no maximum or minimum values, however a higher score indicates improved performance on the cognitive constructs. The change score is change from baseline to month 6.
Time frame: Baseline and 6 Months
Change From the Acute Phase Baseline to the End (Month 12) of the Double-blind Treatment in the Positive and Negative Syndrome Scale (PANSS)
The PANSS is an interview-based measure of psychopathology severity in adults with psychotic disorders. Thirty items are rated using a Likert scale, from 1 - 7. The PANSS total score is the sum of thirty items ranging from 30 to 210 (higher score representing a worsening in psychosis).
Time frame: Baseline and 12 months
Change From the Acute Phase Baseline to the End (Month 12) of the Double-blind Treatment in the Clinical Global Impression Severity Scale (CGI-S) Scores
The CGI-S is a clinician-rated assessment of the subject's current illness state on a scale ranging from 1-7, where a higher score is associated with greater illness severity.
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K&S Professional Research Services, LLC
Little Rock, Arkansas, United States
Woodland International Research Group
Little Rock, Arkansas, United States
Comprehensive Neuroscience, Inc
Cerritos, California, United States
Clinical Innovations, Inc.
Costa Mesa, California, United States
Synergy Escondido,710 East Grand Ave.
Escondido, California, United States
Collaborative Neuroscience Network Inc
Garden Grove, California, United States
Apostle Clinical Trials, Inc.
Long Beach, California, United States
California Clinical Trials
Paramount, California, United States
Pasadena Research Institute
Pasadena, California, United States
CNRI - Los Angeles LLC,8309 Telegraph Road
Pico Rivera, California, United States
...and 55 more locations
Time frame: Baseline and 12 months