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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | AZD8529 40 mg |
|
| 2 | Placebo Comparator | Placebo |
|
| 3 | Other | Risperidone 4 mg (2mg on Day 1) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AZD 8529 | Drug | 40mg oral daily capsule administered as a single dose in the morning for 28 days |
| |
| Measure | Description | Time Frame |
|---|---|---|
| PANSS Total Score | Prior to randomization (screening, admission to washout/run in, baseline) and Days 8, 15, 22, and 28 |
| Measure | Description | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Robert, Litman, M.D | CBH Health9605 Medical Center Drive Suite 270Rockville, MD, 20850 | Principal Investigator |
| Mark Smith | AstraZeneca1800 Concord PikeWilmington, DE, 19850 | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Garden Grove | California | United States | |||
| Research Site |
| Type | Date | Date Unknown |
|---|---|---|
| Release | Aug 18, 2020 | |
| Unrelease | Aug 25, 2020 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Aug 18, 2020 | Aug 25, 2020 |
| ID | Term |
|---|---|
| D012559 | Schizophrenia |
| D006212 | Hallucinations |
| D010259 | Paranoid Disorders |
| ID | Term |
|---|---|
| D019967 | Schizophrenia Spectrum and Other Psychotic Disorders |
| D001523 | Mental Disorders |
| D010468 | Perceptual Disorders |
| D019954 | Neurobehavioral Manifestations |
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| ID | Term |
|---|---|
| D018967 | Risperidone |
| ID | Term |
|---|---|
| D011744 | Pyrimidinones |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| Risperidone |
| Drug |
4mg (2mg on Day 1) oral daily capsule administered as a single dose in the evening for 28 days |
|
|
| Placebo to match AZD8529 | Drug | 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 |
|
| Placebo to match risperidone | Drug | 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 |
|
| 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 |
| Glendale |
| California |
| United States |
| Research Site | Rockville | Maryland | United States |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |