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Since AZD0328 is unlikely to meet the current Target Product Profile, Astrazeneca decided to stop further development of AZD0328
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This study is to assess the pharmacodynamics, pharmacokinetics, safety and tolerability of multiple ascending doses of AZD0328 in patients with schizophrenia
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | AZD0328 low dose |
|
| 2 | Experimental | AZD0328 Optimal dose |
|
| 3 | Experimental | AZD0328 High dose |
|
| 4 | Placebo Comparator | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AZD0328 | Drug |
| ||
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| CogState Groton Maze Learning Task (GMLT) and One Card Learning Task (OCLT) Standardized Composite Score at Day 14 | The GMLT and OCLT standardized change composite score will be calculated as the mean of the GMLT and OCLT standardized change from baseline scores. Least square means were derived using a mixed effects repeated measures model with protocol scheduled assessment day, treatment group, baseline score, and assessment day-by-treatment interaction as fixed factors, center as a random factor, and baseline score as a covariate. Scale range from negative infinity (worst value) to positive infinity (best value). | Baseline and Day 14 |
| Measure | Description | Time Frame |
|---|---|---|
| CogState Groton Maze Learning Task (GMLT) Standardized Change Score at Day 14 | GMLT score is defined as the -log10 transform of the sum of the number of errors made during GMLT trials. Mean GMLT score was calculated as the average of the 2 hour, 5 hour, and 8 hour scores. The GMLT standardized change score was calculated as the change from baseline in the mean GMLT score divided by the within subject standard deviation. Scale range from negative infinity (worst value) to positive infinity (best value). |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Center | Garden Grove | California | United States | |||
| Research Center |
Patients were to receive a stable dose of an antipsychotic for the 4 weeks prior to randomization, have stable psychotic symptoms without a hospitalization for the 8 weeks prior to randomization, and were to be smoking an average of >=10 cigarettes per day. Enrolled patients who no longer met entry criteria at randomization were not randomized.
A total of two US centers were inititated with first patient enrolled on 2 April 2008 and last patient completed on 4 November 2008. A total of 158 patients were enrolled with 100 patients allocated to randomized treatment.
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| ID | Title | Description |
|---|---|---|
| FG000 | AZD0328 Low Dose Group | AZD0328 Low dose group (0.00093 to 0.0028 mg oral solution) |
| FG001 | AZD0328 Optimal Dose Group | AZD0328 Optimal dose group (0.0048 to 0.0329 mg oral solution) |
| FG002 | AZD0328 High Dose Group | AZD0328 High dose group (0.075 to 0.675 mg oral solution) |
| FG003 | Placebo | Placebo |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | AZD0328 Low Dose Group | AZD0328 Low dose group (0.00093 to 0.0028 mg oral solution) |
| BG001 | AZD0328 Optimal Dose Group | AZD0328 Optimal dose group (0.0048 to 0.0329 mg oral solution) |
| 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 | CogState Groton Maze Learning Task (GMLT) and One Card Learning Task (OCLT) Standardized Composite Score at Day 14 | The GMLT and OCLT standardized change composite score will be calculated as the mean of the GMLT and OCLT standardized change from baseline scores. Least square means were derived using a mixed effects repeated measures model with protocol scheduled assessment day, treatment group, baseline score, and assessment day-by-treatment interaction as fixed factors, center as a random factor, and baseline score as a covariate. Scale range from negative infinity (worst value) to positive infinity (best value). | Posted | Least Squares Mean | Standard Error | units on a scale | Baseline and Day 14 |
|
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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 | AZD0328 Low Dose Group | AZD0328 Low dose group (0.00093 to 0.0028 mg oral solution) |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pulmonary Embolism | Respiratory, thoracic and mediastinal disorders | MedDRA 11.1 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| DYSPEPSIA | Gastrointestinal disorders | MedDRA 10.0 | 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 |
|---|---|
| C543642 | spiro(1-azabicyclo(2.2.2)octane-3,2'(3H)-furo(2,3-b)pyridine) |
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|
| Baseline and Day 14 |
| CogState One Card Learning Task (OCLT) Standardized Change Score at Day 14 | OCLT score is defined as the arcsine transform of the proportion of correct responses during OCLT trials. Mean OCLT score was calculated as the average of the 2 hour, 5 hour, and 8 hour scores. The OCLT standardized change score was calculated as the change from baseline in the mean OCLT score divided by the within-subject standard deviation. Scale range from negative infinity (worst value) to positive infinity (best value). | Baseline and Day 14 |
| CogState Detection Task (DT) Standardized Change Score at Day 14 | DT score is defined as -1 times the mean of log10 transformed reaction times for all correct responses. Mean DT score was calculated as the average of the 2 hour, 5 hour, and 8 hour scores. The DT standardized change score will be calculated as the change from baseline in the mean DT score divided by the within-subject standard deviation. Score range from negative infinity (worst value) to positive infinity (best value). | Baseline and Day 14 |
| CogState Identification Task (IT) Standardized Change Score at Day 14 | IT score defined as 1 times the mean of log10 transformed reaction times for all correct responses. Mean IT score calculated as the average of the 2 hour, 5 hour, and 8 hour scores. The IT standardized change score will be calculated as the change from baseline in the mean IT score divided by the within-subject standard dev. Least square means were derived using a mixed effects repeated measures model with protocol scheduled assessment day, treatment group, baseline score, and assessment day-by-treatment interaction as fixed factors, center as a random factor, and baseline score as a covariate | Baseline and Day 14 |
| CogState Groton Maze Recall Task (GMRT) Standardized Change Score at Day 14 | GMRT score defined as the -log10 transform of the sum of the number of errors made during GMRT trials. Mean GMRT score calculated as the average of the 2 hour, 5 hour, and 8 hour scores. The GMRT standardized change score was calculated as change from baseline in mean GMRT score divided by the within subject standard deviation. Least square means were derived using a mixed effects repeated measures model with protocol scheduled assessment day, treatment group, baseline score, assessment day-by-treatment interaction as fixed factors, center as random factor, and baseline score as a covariate | Baseline and Day 14 |
| Glendale |
| California |
| United States |
| Withdrawal by Subject |
|
| Lost to Follow-up |
|
| Protocol Violation |
|
| BG002 | AZD0328 High Dose Group | AZD0328 High dose group (0.075 to 0.675 mg oral solution) |
| BG003 | Placebo | Placebo |
| BG004 | Total | Total of all reporting groups |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Number | Participants |
|
| Baseline Positive and Negative Syndrome Scale (PANSS) total score | Baseline Positive and Negative Syndrome Scale (PANSS) total score. Best value for PANSS total score = 30 to worse value for PANSS total score = 210 | Mean | Standard Deviation | Points of PANSS score |
|
| AZD0328 Optimal Dose Group |
AZD0328 Optimal dose group (0.0048 to 0.0329 mg oral solution) |
| OG002 | AZD0328 High Dose Group | AZD0328 High dose group (0.075 to 0.675 mg oral solution) |
| OG003 | Placebo | Placebo |
|
|
| Secondary | CogState Groton Maze Learning Task (GMLT) Standardized Change Score at Day 14 | GMLT score is defined as the -log10 transform of the sum of the number of errors made during GMLT trials. Mean GMLT score was calculated as the average of the 2 hour, 5 hour, and 8 hour scores. The GMLT standardized change score was calculated as the change from baseline in the mean GMLT score divided by the within subject standard deviation. Scale range from negative infinity (worst value) to positive infinity (best value). | Posted | Least Squares Mean | Standard Error | units on a scale | Baseline and Day 14 |
|
|
|
| Secondary | CogState One Card Learning Task (OCLT) Standardized Change Score at Day 14 | OCLT score is defined as the arcsine transform of the proportion of correct responses during OCLT trials. Mean OCLT score was calculated as the average of the 2 hour, 5 hour, and 8 hour scores. The OCLT standardized change score was calculated as the change from baseline in the mean OCLT score divided by the within-subject standard deviation. Scale range from negative infinity (worst value) to positive infinity (best value). | Posted | Least Squares Mean | Standard Error | units on a scale | Baseline and Day 14 |
|
|
|
| Secondary | CogState Detection Task (DT) Standardized Change Score at Day 14 | DT score is defined as -1 times the mean of log10 transformed reaction times for all correct responses. Mean DT score was calculated as the average of the 2 hour, 5 hour, and 8 hour scores. The DT standardized change score will be calculated as the change from baseline in the mean DT score divided by the within-subject standard deviation. Score range from negative infinity (worst value) to positive infinity (best value). | Posted | Least Squares Mean | Standard Error | units on a scale | Baseline and Day 14 |
|
|
|
| Secondary | CogState Identification Task (IT) Standardized Change Score at Day 14 | IT score defined as 1 times the mean of log10 transformed reaction times for all correct responses. Mean IT score calculated as the average of the 2 hour, 5 hour, and 8 hour scores. The IT standardized change score will be calculated as the change from baseline in the mean IT score divided by the within-subject standard dev. Least square means were derived using a mixed effects repeated measures model with protocol scheduled assessment day, treatment group, baseline score, and assessment day-by-treatment interaction as fixed factors, center as a random factor, and baseline score as a covariate | Posted | Least Squares Mean | Standard Error | unit on a scale | Baseline and Day 14 |
|
|
|
| Secondary | CogState Groton Maze Recall Task (GMRT) Standardized Change Score at Day 14 | GMRT score defined as the -log10 transform of the sum of the number of errors made during GMRT trials. Mean GMRT score calculated as the average of the 2 hour, 5 hour, and 8 hour scores. The GMRT standardized change score was calculated as change from baseline in mean GMRT score divided by the within subject standard deviation. Least square means were derived using a mixed effects repeated measures model with protocol scheduled assessment day, treatment group, baseline score, assessment day-by-treatment interaction as fixed factors, center as random factor, and baseline score as a covariate | Posted | Least Squares Mean | Standard Error | unit on a scale | Baseline and Day 14 |
|
|
|
| 0 |
| 23 |
| 17 |
| 23 |
| EG001 | AZD0328 Optimal Dose Group | AZD0328 Optimal dose group (0.0048 to 0.0329 mg oral solution) | 0 | 37 | 22 | 37 |
| EG002 | AZD0328 High Dose Group | AZD0328 High dose group (0.075 to 0.675 mg oral solution) | 0 | 18 | 11 | 18 |
| EG003 | Placebo | Placebo | 1 | 22 | 11 | 22 |
| HEADACHE | Nervous system disorders | MedDRA 11.1 | Systematic Assessment |
|
| MYALGIA | Musculoskeletal and connective tissue disorders | MedDRA 11.1 | Systematic Assessment |
|
| NAUSEA | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
|
| CONSTIPATION | Gastrointestinal disorders | MedDRA 11.1 | Systematic Assessment |
|
| INSOMNIA | Psychiatric disorders | MedDRA 11.1 | Systematic Assessment |
|
| LETHARGY | Nervous system disorders | MedDRA 11.1 | Systematic Assessment |
|
| SEDATION | Nervous system disorders | MedDRA 11.1 | Systematic Assessment |
|
| ANXIETY | Psychiatric disorders | MedDRA 11.1 | Systematic Assessment |
|
| COUGH | Respiratory, thoracic and mediastinal disorders | MedDRA 11.1 | Systematic Assessment |
|
| NASAL CONGESTION | Respiratory, thoracic and mediastinal disorders | MedDRA 11.1 | Systematic Assessment |
|
| TOOTHACHE | Gastrointestinal disorders | MedDRA 11.1 | Systematic Assessment |
|
No publication or presentation of results until the earlier of the publication of the first multi-center publication and the second anniversary of the completion of the multi-center study at all sites. Sponsor must receive a copy of proposed manuscript for review and comment at least 60 days prior to its submission for publication or presentation.