Schizophrenia
Conditions
Keywords
Schizophrenia, Hallucinations, Paranoia, Inpatient schizophrenia clinical trial
Brief summary
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.
Interventions
DRUGAZD 8529
40mg oral daily capsule administered as a single dose in the morning for 28 days
DRUGRisperidone
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
DRUGPlacebo to match risperidone
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
Sponsors
AstraZeneca
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Patient will need to read, understand and sign an informed consent prior to any study specific procedures * Patient will have certain schizophrenia symptoms deemed by the investigator as appropriate for the study entry
Exclusion criteria
* Patients will be excluded based on recent history of significant illness or current disease as assessed by the investigator during screening process (based on physical examination, laboratory studies and electrocardiogram studies) * Patients will be excluded if urine drug screen test show positive results * Smoking of more than 2 packs of cigarettes a day
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| PANSS Total Score | Prior to randomization (screening, admission to washout/run in, baseline) and Days 8, 15, 22, and 28 |
Secondary
| Measure | Time frame |
|---|---|
| PANSS Positive, Negative, and General Psychopathology Subscale Scores | Prior to randomization (screening, admission to washout/run in, baseline) and Days 8, 15, 22, and 28 |
| CGI-S | 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 | Prior to randomization (screening, admission to washout/run in, baseline) and Days 1, 8, 15, 22, and 28 |
Countries
United States
Outcome results
None listed