The purpose of this study is to evaluate the efficacy of the drug SM-13496 compared to a placebo and to haloperidol in patients with schizophrenia.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
356
Lurasidone 20mg/day tablets
Lurasidone 40mg/day tablets
Lurasidone 80mg/day - 2 40mg tablets
Change From Baseline to the End of the Double-blind Treatment in the BPRS (Brief Psychiatric Rating Scale)Total Score
The BPRS consists of 18 ordered categorical items (from "not present" to "extremely severe," on a 1- to 7-point scale), each developed to assess patient symptomatology in a relatively discrete symptom area. The BPRS will be extracted from the PANSS by adding the scores of the 18 items (P2 to P7, N1, N2, and G1 to G10) of the PANSS and will not be assessed separately. The minimum score on the BPRS is 18 and the maximum is 126. The higher number indicates a worsening of schizophrenia.
Time frame: Baseline and 6 weeks
Change From Baseline to the End of the Double-blind Treatment in the PANSS (Positive and Negative Syndrome Scale) Scores
The PANSS Positive and Negative Syndrome Scale)is a 30-item scale that evaluates positive, negative, and other symptoms in patients with schizophrenia. Each item is rated on a 7-point scale that ranges from 1 (absent) to 7 (extreme). Scores range from 30-210 with higher scores representing a worsening of schizophrenia.
Time frame: Baseline and 6 weeks
Change From Baseline to the End of the Double-blind Treatment in the CGI-S (Clinical Global Impression of Severity) Scores
The CGI Severity (CGI-S) assesses the severity of illness of the patient relative to the particular population on a 7-point scale ranging from 1 (normal, not at all ill) to 7 (among the most extremely ill patients).
Time frame: Baseline and 6 weeks
Change From Baseline to the End of the Double-blind Treatment in the MADRS (Montgomery Asberg-Depression Scale) Scores
The MADRS is a 10-item rating scale that assesses apparent and reported sadness, lassitude, pessimism, inner tension, suicidality, reduced sleep or appetite, difficulty in concentration, and lack of interest. Each item is scored on a 7-point scale with a score of 0 reflecting no symptoms and a score of 6 reflecting symptoms of maximum severity.
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Haloperidol 10mg/day tablets
Matching Placebo to Lurasdione and Haloperidol
Birmingham Psychiatry Pharmaceutical
Birmingham, Alabama, United States
Institute for Psychopharmacology Research
Cerritos, California, United States
CNS Network
Garden Grove, California, United States
California Clinical Trials Medical Group
Glendale, California, United States
Optimum Health Services
La Mesa, California, United States
University of California, Irvine
Orange, California, United States
Affiliated Research Institute
San Diego, California, United States
Sharp Mesa Vista Hospital
San Diego, California, United States
California Neuropsychopharmacolgoy Clinical Research Insitute
San Diego, California, United States
Comprehensive Neuroscience. Inc.
Washington D.C., District of Columbia, United States
...and 24 more locations
Time frame: Baseline and 6 weeks