The purpose of this study is to determine whether treatment with daily oral dose of AZD8529 40 mg administered over 28 days is safe, well tolerated and improves main symptoms of schizophrenia in adult schizophrenia patients.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
296
40mg oral daily capsule administered as a single dose in the morning for 28 days
4mg (2mg on Day 1) oral daily capsule administered as a single dose in the evening for 28 days
Placebo to match AZD8529 administered as a daily capsule in the morning for 28 days during the treatment period and also during the 3-7 day washout or run-in period
Research Site
Garden Grove, California, United States
Research Site
Glendale, California, United States
Research Site
Rockville, Maryland, United States
PANSS Total Score
Time frame: Prior to randomization (screening, admission to washout/run in, baseline) and Days 8, 15, 22, and 28
PANSS Positive, Negative, and General Psychopathology Subscale Scores
Time frame: Prior to randomization (screening, admission to washout/run in, baseline) and Days 8, 15, 22, and 28
CGI-S
Time frame: Prior to randomization (screening, admission to washout/run in, baseline) and Days 8, 15, 22, and 28
Vital signs measurements, body weight, physical exam, clinical laboratory evaluations, ECGs, Extrapyramidal Symptoms, suicidal symptoms, cognition and incidence of adverse events
Time frame: Prior to randomization (screening, admission to washout/run in, baseline) and Days 1, 8, 15, 22, and 28
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Placebo to match risperidone administered as a daily capsule in the evening for 28 days during the treatment period and also during the 3-7 day washout or run-in period