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 short term among acutely psychotic patients with chronic schizophrenia.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
488
Lurasidone 80 mg tablets
Lurasidone 4 40 mg tablets
Quetiapine XR 600mg
Primary Efficacy Endpoint: Mean Change in Total PANSS Score From Baseline to the End of the Double Blind Phase
The PANSS (Positive and Negative Syndrome Scale) is a 30-item scale (range 30-210) designed to assess various symptoms of schizophrenia including delusions, grandiosity, blunted affect, poor attention, and poor impulse control. The 30 symptoms are rated on a 7-point scale that ranges from 1 (absent) to 7 (extreme psychopathology). The PANSS total score consists of the sum of all 30 PANSS items. Higher scores indicate worsening.
Time frame: Week 6
Secondary Outcome: CGI-S From Baseline to the End of the Double-blind Treatment
Clinical Global Impression of Severity is a clinician-rated assessment of the subject's current illness state on a 7 point scale, where a higher score is associated with greater illness severity. The scale has a single item measured on a 7 point scale from 1 ('normal', not ill) to 7 (extremely ill).
Time frame: 6-Weeks
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Matching Placebo to Lurasidone or Quetiapine
K&S Professional Research Services, LLC
Little Rock, Arkansas, United States
Woodland International Research Group
Little Rock, Arkansas, United States
Clinical Pharmacological Studies, Inc.
Cerritos, California, United States
Comprehensive Neuroscience, Inc
Cerritos, California, United States
Clinical Innovations, Inc.
Costa Mesa, California, United States
Synergy Escondido
Escondido, California, United States
Collaborative Neuroscience Network
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
...and 55 more locations