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This study is designed to assess the effects of AZD 2624 in patients with schizophrenia
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AZD2624 | Experimental | AZD2624 40 mg |
|
| Olanzapine | Other | Olanzapine 15 mg |
|
| Placebo | Placebo Comparator | Matching Placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AZD2624 | Drug | Oral Suspension |
| |
| Olanzapine |
| Measure | Description | Time Frame |
|---|---|---|
| Positive and Negative Syndrome Scale (PANSS) Total Score Change From Baseline | PANSS total score, sum of 30 item scores (each on a 0 to 7 scale), assesses positive and negative symptoms of psychopathology on a continuous scale from 0 (the best) to 210 (the worst). Day 28 value was calculated using last observation carried forward (LOCF). Change from baseline was calculated as Day 28 value minus baseline value. | Baseline, Day 28 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Dhaval Desai, MD | AstraZeneca | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Rockville | Maryland | United States |
Patients were screened up to 21 days, and admitted to the Clinical Research Unit (CRU) for a maximum of 2 days until eligibility was determined. Once eligibility was determined, patients currently on medication entered a 7 days washout period, patients not currently on medication had a 3 day washout, prior to randomization to study medication.
A total of 2 centers in the US were initiated and enrolled patients. 159 patients enrolled, of which 106 randomized
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| ID | Title | Description |
|---|---|---|
| FG000 | AZD2624 | AZD2624 40 mg |
| FG001 | Placebo | Matching Placebo |
| FG002 | Olanzapine | Olanzapine 15 mg |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | AZD2624 | AZD2624 40 mg |
| BG001 | Placebo | Matching Placebo |
| BG002 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Positive and Negative Syndrome Scale (PANSS) Total Score Change From Baseline | PANSS total score, sum of 30 item scores (each on a 0 to 7 scale), assesses positive and negative symptoms of psychopathology on a continuous scale from 0 (the best) to 210 (the worst). Day 28 value was calculated using last observation carried forward (LOCF). Change from baseline was calculated as Day 28 value minus baseline value. | Posted | Mean | Standard Error | Points on a scale | Baseline, Day 28 |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | AZD2624 | AZD2624 40 mg |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Psychotic disorder | Psychiatric disorders | MedDRA 11.1 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Headache | Nervous system disorders | MedDRA 11.1 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Gerard Lynch | Astrazeneca | aztrial_results_posting@astrazeneca.com |
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| ID | Term |
|---|---|
| D012559 | Schizophrenia |
| ID | Term |
|---|---|
| D019967 | Schizophrenia Spectrum and Other Psychotic Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| C555357 | 3-((methylsulfonyl)amino)-2-phenyl-N-(1-phenylpropyl)quinolin-4-carboxamide |
| D000077152 | Olanzapine |
| ID | Term |
|---|---|
| D001569 | Benzodiazepines |
| D001552 | Benzazepines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
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| Drug |
PO BID |
|
|
| Placebo | Drug |
|
| Lack of Efficacy |
|
| Other |
|
| Safety Reasons |
|
| Olanzapine |
Olanzapine 15 mg |
| BG003 | Total | Total of all reporting groups |
| Year |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Olanzapine |
Olanzapine 15 mg |
|
|
| 4 |
| 43 |
| 29 |
| 43 |
| EG001 | Placebo | Matching Placebo | 2 | 41 | 27 | 41 |
| EG002 | Olanzapine | Olanzapine 15 mg | 0 | 22 | 18 | 22 |
| Weight Increased | Investigations | MedDRA 11.1 | Systematic Assessment |
|
| Sedation | Nervous system disorders | MedDRA 11.1 | Systematic Assessment |
|
| Somnolence | Nervous system disorders | MedDRA 11.1 | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA 11.1 | Systematic Assessment |
|
| Musculoskeletal Pain | Musculoskeletal and connective tissue disorders | MedDRA 11.1 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA 11.1 | Systematic Assessment |
|
| Psychotic Disorder | Psychiatric disorders | MedDRA 11.1 | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA 11.1 | Systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA 11.1 | Systematic Assessment |
|
| Increased Appetite | Metabolism and nutrition disorders | MedDRA 11.1 | Systematic Assessment |
|
| Stomach Discomfort | Gastrointestinal disorders | MedDRA 11.1 | Systematic Assessment |
|
| Decreased Appetite | Metabolism and nutrition disorders | MedDRA 11.1 | Systematic Assessment |
|
| Back Pain | Musculoskeletal and connective tissue disorders | MedDRA 11.1 | Systematic Assessment |
|
| Dry Mouth | Gastrointestinal disorders | MedDRA 11.1 | Systematic Assessment |
|
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| D006571 | Heterocyclic Compounds |