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| ID | Type | Description | Link |
|---|---|---|---|
| 2010-020579-21 | EudraCT Number |
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This will be a phase IV 20 -32 day prospective, double blind, double-dummy, randomised crossover study that will evaluate the effect of quetiapine XR and quetiapine IR on cognitive performance in patients with schizophrenia stabilized on a single antipsychotic medication.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| First Seroquel XR then Seroquel IR | Active Comparator | Patients randomised to Seroquel XR will have treatment for 10-16 days and after that cross-over to treatment with Seroquel IR for 10-16 days |
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| First Seroquel IR then Seroquel XR | Active Comparator | Patients randomised to Seroquel IR will have treatment for 10-16 days and after that cross-over to treatment with Seroquel XR for 10-16 days |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Seroquel XR- quetiapine fumarate extended release | Drug | Seroquel XR dose 400-700 mg (in tablet form). The investigator established the dosing schedule for each patient depending on the patient's dose when entering the study. The patients continued on the same dose during the study as they had prior to enrolment. Dose taken once a day for 10-16 days. |
| Measure | Description | Time Frame |
|---|---|---|
| Mean for Attentional Standardised Composite Score Based on Performance Scores From the CogState Test Battery Domains Detection (Speed of Processing)and Identification (Attention/Vigilance) | Attentional standardised composite score: Standardised speed of performance score. Higher Score=better performance. Score range minus infinity to plus infinity. Measured at baseline (before study drug administration) and in Period 1 at 3 visits,(post 1),(post 2),(post 3), in a 5-day (maximum 8 day) period. (Last test day not earlier than after 10 days of randomised)and in Period 2 at 3 visits,(post 1),(post 2),(post 3), in a 5-day (maximum 8 day) period. Last test day not earlier than after 10 days of crossover treatment. | Period 1 at 3 visits,(post 1),(post 2),(post 3), in a 5-day (maximum 8 day) period. Period 2 at 3 visits,(post 1),(post 2),(post 3), in a 5-day (maximum 8 day) period. |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Treatment Satisfaction for Treatment Satisfaction Questionnaire of Medication (TSQM) | TSQM is a 14-item questionnaire with 4 sub-scales: effectiveness of the medication; treatment side effects; convenience of the medication; global satisfaction with the medication. Scale range 0-100 for each sub-scale, higher=greater satisfaction/milder side effects/greater convenience/greater overall satisfaction. There are 2 measurement, (after the start of taking study drug) one at end of period 1 and one at end of period 2. That is one measurement per patient per treatment. The mean of all the patients is presented, one mean value per treatment group. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Eva Dencker Vansvik | AstraZeneca | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Vienna | Austria | ||||
| Research Site |
Screening (0 days to 14 days before enrolment), enrolment at Visit 1 (14 days to 3 days prior to randomisation), randomisation at Visit 2 after confirmation of eligibility. 75 patients were screened/enrolled. Of these, 9 were not randomised; 2 patients due to own decision to discontinue and 7 patients due to eligibility criteria not fulfilled.
Patients were recruited at 20 study centres in 5 countries: Austria (1 site), Denmark (1 site), Germany (6 sites), Italy (9 sites) and Spain (3 sites). Recruitment started 2 November 2010 and was completed 29 June 2011. The last patient completed the study on 3 August 2011.
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| ID | Title | Description |
|---|---|---|
| FG000 | First Seroquel XR Then Seroquel IR | Patients randomised to Seroquel XR will have treatment for 10-16 days and after that cross-over to treatment with Seroquel IR for 10-16 days |
| FG001 | First Seroquel IR Then Seroquel XR |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Period 1, First Intervention |
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| Seroquel IR - quetiapine fumarate | Drug | Seroquel IR dose 400-700 mg (in tablet form). The investigator established the dosing schedule for each patient depending on the patient's dose when entering the study. The patients continued on the same dose during the study as they had prior to enrolment. Dose taken twice a day for 10-16 days. |
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| Placebo matching Seroquel XR | Drug | Placebo matching Seroquel XR dose 400-700 mg (in tablet form). Dose taken once a day for 10-16 days. |
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| Placebo matching Seroquel IR | Drug | Placebo matching Seroquel IR dose 400-700 mg (in tablet form). Dose taken twice a day for 10-16 days. |
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| Before taking study drug, end of Period 1 and end of Period 2 |
| Mean Daytime Cognitive Performance Using CogState: - Working Memory - Verbal Learning) -Reasoning and Problem Solving | International Shopping List Task (ISLT): measures reasoning and problem solving. Min=minus infinity, max=plus infinity, higher score=better performance. Groton Maze Learning Test (GMLT): measures reasoning and problem solving. Min=minus infinity, max=plus infinity, lower score=better performance. Lower=better performance. One Back memory task (ONB: measures working memory, min=minus infinity, max=plus infinity, lower score=better performance. | Period 1 at 3 visits,(post 1),(post 2),(post 3), in a 5-day (maximum 8 day) period. Period 2 at 3 visits,(post 1),(post 2),(post 3), in a 5-day (maximum 8 day) period. |
| Mean Overall Sedation as Measured by the Modified Bond-Lader Visual Analogue Scale (VAS) When Administered According to Label | The modified Bond-Lader VAS: The degree of sedation was marked by the patient on a 100 mm VAS ranging between Alert (=0 mm) and Drowsy (=100 mm). The marked length in millimetres. There are 3 assessments made in each period (post 1, 2 and 3 for each period). That is three measurements per patient per treatment. The mean is an overall mean of all the recordings in all patients, one mean value per treatment group. | Period 1 at 3 visits,(post 1),(post 2),(post 3), in a 5-day (maximum 8 day) period. Period 2 at 3 visits,(post 1),(post 2),(post 3), in a 5-day (maximum 8 day) period. |
| Mean Overall Sedation as Measured by the Stanford Sleepiness Scale When Administered According to Label | Stanford Sleepiness Scale: The sleepiness was assessed by the patient on a 7 item rating scale ranging from 1 (Feeling active and vital) to 7 (Almost in reverie). There are 3 assessments made in each period (post 1, 2 and 3 for each period). That is three measurements per patient per treatment. The mean is an overall mean of all the recordings in all patients, one mean value per treatment group. | Period 1 at 3 visits,(post 1),(post 2),(post 3), in a 5-day (maximum 8 day) period. Period 2 at 3 visits,(post 1),(post 2),(post 3), in a 5-day (maximum 8 day) period. |
| Number of Dropouts. | The number of patients who dropped out was counted. | Period 1 and Period 2 |
| Mean Ratio of Morning Plasma Concentration of Quetiapine and Nor-quetiapine for Quetiapine IR and Quetiapine XR, at Steady-state Conditions in the End of Each Treatment Period 1 and 2. | The ratio was derived as individual plasma concentration of quetiapine divided by the plasma concentration of nor-quetiapine. The mean ratio was derived for each treatment, XR and IR, respectively. | End of Period 1, end of Period 2 |
| Middelfart |
| Denmark |
| Research Site | Berlin | Germany |
| Research Site | Bochum | Germany |
| Research Site | Hamburg | Germany |
| Research Site | München | Germany |
| Research Site | Rottweil | Germany |
| Research Site | Giarre | CT | Italy |
| Research Site | Genova | GE | Italy |
| Research Site | Lido di Camaiore | LU | Italy |
| Research Site | Barakaldo (vizcaya) | Pais Vasco | Italy |
| Research Site | Tivoli | RM | Italy |
| Research Site | Sant'Arsenio | SA | Italy |
| Research Site | Sassari | SS | Italy |
| Research Site | Borgomanero | Italy |
| Research Site | Catania | Italy |
| Research Site | Roma | Italy |
| Research Site | Torre Annunziata | Italy |
| Research Site | Salamanca | Castille and León | Spain |
| Research Site | Zamora | Castille and León | Spain |
Patients randomised to Seroquel IR will have treatment for 10-16 days and after that cross-over to treatment with Seroquel XR for 10-16 days
| COMPLETED |
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| NOT COMPLETED |
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| Period 2, Second Intervention |
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| ID | Title | Description |
|---|---|---|
| BG000 | First Seroquel XR Then Seroquel IR | Patients randomised to Seroquel XR will have treatment for 10-16 days and after that cross-over to treatment with Seroquel IR for 10-16 days |
| BG001 | First Seroquel IR Then Seroquel XR | Patients randomised to Seroquel IR will have treatment for 10-16 days and after that cross-over to treatment with Seroquel XR for 10-16 days |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age Continuous | Of the 66 patients randomised to treatment with XR or IR only 65 patients took any study drug. One patient withdrew before taking any study drug. 65 patients were analysed for baseline age. | Number | participants |
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| Age Continuous | Of the 66 patients randomised to treatment with XR or IR only 65 patients took any study drug. One patient withdrew before taking any study drug. 65 patients were analysed for baseline measure age. | Mean | Standard Deviation | years |
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| Gender | Of the 66 patients randomised to treatment with XR or IR only 65 patients took any study drug. One patient withdrew before taking any study drug. 65 patients were analysed for baseline measure gender. | Number | participants |
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| Region of Enrollment | Number | participants |
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| 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 | ||||||||||||||||||||||||||||||
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| Primary | Mean for Attentional Standardised Composite Score Based on Performance Scores From the CogState Test Battery Domains Detection (Speed of Processing)and Identification (Attention/Vigilance) | Attentional standardised composite score: Standardised speed of performance score. Higher Score=better performance. Score range minus infinity to plus infinity. Measured at baseline (before study drug administration) and in Period 1 at 3 visits,(post 1),(post 2),(post 3), in a 5-day (maximum 8 day) period. (Last test day not earlier than after 10 days of randomised)and in Period 2 at 3 visits,(post 1),(post 2),(post 3), in a 5-day (maximum 8 day) period. Last test day not earlier than after 10 days of crossover treatment. | The per protocol set (PPS) is a subset of the FAS consisting of patients who fulfilled all inclusion criteria but none of the exclusion criteria, complied with study medication dosing scheme, did not violate any of the study restrictions and completed the study without protocol violation. | Posted | Mean | Standard Deviation | standardised units | Period 1 at 3 visits,(post 1),(post 2),(post 3), in a 5-day (maximum 8 day) period. Period 2 at 3 visits,(post 1),(post 2),(post 3), in a 5-day (maximum 8 day) period. |
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| Secondary | Mean Treatment Satisfaction for Treatment Satisfaction Questionnaire of Medication (TSQM) | TSQM is a 14-item questionnaire with 4 sub-scales: effectiveness of the medication; treatment side effects; convenience of the medication; global satisfaction with the medication. Scale range 0-100 for each sub-scale, higher=greater satisfaction/milder side effects/greater convenience/greater overall satisfaction. There are 2 measurement, (after the start of taking study drug) one at end of period 1 and one at end of period 2. That is one measurement per patient per treatment. The mean of all the patients is presented, one mean value per treatment group. | Full Analysis Set (FAS)used for efficacy analysis included all patients who in both study periods, received at least 1 dose of investigational product and for whom post-dose efficacy data was available. | Posted | Mean | Standard Deviation | units on a scale | Before taking study drug, end of Period 1 and end of Period 2 |
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| Secondary | Mean Daytime Cognitive Performance Using CogState: - Working Memory - Verbal Learning) -Reasoning and Problem Solving | International Shopping List Task (ISLT): measures reasoning and problem solving. Min=minus infinity, max=plus infinity, higher score=better performance. Groton Maze Learning Test (GMLT): measures reasoning and problem solving. Min=minus infinity, max=plus infinity, lower score=better performance. Lower=better performance. One Back memory task (ONB: measures working memory, min=minus infinity, max=plus infinity, lower score=better performance. | Per Protocol (PPS), subset of the FAS consisting of patients who fulfilled all of inclusion but none of exclusion criteria, complied with study medication dosing, did not violate any of the restrictions and completed the study without protocol violation. | Posted | Mean | Standard Deviation | Units on a scale | Period 1 at 3 visits,(post 1),(post 2),(post 3), in a 5-day (maximum 8 day) period. Period 2 at 3 visits,(post 1),(post 2),(post 3), in a 5-day (maximum 8 day) period. |
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| Secondary | Mean Overall Sedation as Measured by the Modified Bond-Lader Visual Analogue Scale (VAS) When Administered According to Label | The modified Bond-Lader VAS: The degree of sedation was marked by the patient on a 100 mm VAS ranging between Alert (=0 mm) and Drowsy (=100 mm). The marked length in millimetres. There are 3 assessments made in each period (post 1, 2 and 3 for each period). That is three measurements per patient per treatment. The mean is an overall mean of all the recordings in all patients, one mean value per treatment group. | The full analysis set (FAS) used for analysis of efficacy included all patients who, in both study periods, received at least one dose of investigational product and for whom post-dose efficacy data are available in both periods. | Posted | Mean | Standard Deviation | units on a scale | Period 1 at 3 visits,(post 1),(post 2),(post 3), in a 5-day (maximum 8 day) period. Period 2 at 3 visits,(post 1),(post 2),(post 3), in a 5-day (maximum 8 day) period. |
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| Secondary | Mean Overall Sedation as Measured by the Stanford Sleepiness Scale When Administered According to Label | Stanford Sleepiness Scale: The sleepiness was assessed by the patient on a 7 item rating scale ranging from 1 (Feeling active and vital) to 7 (Almost in reverie). There are 3 assessments made in each period (post 1, 2 and 3 for each period). That is three measurements per patient per treatment. The mean is an overall mean of all the recordings in all patients, one mean value per treatment group. | The full analysis set (FAS) used for analysis of efficacy included all patients who, in both study periods, received at least one dose of investigational product and for whom post-dose efficacy data are available in both periods. | Posted | Mean | Standard Deviation | units on a scale | Period 1 at 3 visits,(post 1),(post 2),(post 3), in a 5-day (maximum 8 day) period. Period 2 at 3 visits,(post 1),(post 2),(post 3), in a 5-day (maximum 8 day) period. |
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| Secondary | Number of Dropouts. | The number of patients who dropped out was counted. | The Safety analysis set was used, that is all patients who received at least one dose of study medication and for whom any post-dose safety data are available were included in the safety set. | Posted | Number | participants | Period 1 and Period 2 |
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| Secondary | Mean Ratio of Morning Plasma Concentration of Quetiapine and Nor-quetiapine for Quetiapine IR and Quetiapine XR, at Steady-state Conditions in the End of Each Treatment Period 1 and 2. | The ratio was derived as individual plasma concentration of quetiapine divided by the plasma concentration of nor-quetiapine. The mean ratio was derived for each treatment, XR and IR, respectively. | 21 patients for the FAS were analysed. This outcome measure was introduced as a protocol amendment after study start and plasma concentration was not measured in all patients. FAS is all patients who, in both study periods, received at least one dose of investigational product and for whom post-dose efficacy data are available in both periods. | Posted | Mean | Standard Deviation | Ratio | End of Period 1, end of Period 2 |
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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 | Seroquel XR | Patients treated with at least one dose of Seroquel XR | 0 | 63 | 4 | 63 | ||
| EG001 | Seroquel IR | Patients treated with at least one dose of Seroquel IR | 0 | 62 | 4 | 62 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| neutropenia | Blood and lymphatic system disorders | MedDRA (14.0) | Non-systematic Assessment |
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| tachycardia | Cardiac disorders | MedDRA (14.0) | Non-systematic Assessment |
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| vertigo | Ear and labyrinth disorders | MedDRA (14.0) | Non-systematic Assessment |
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| fatigue | General disorders | MedDRA (14.0) | Non-systematic Assessment |
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| heart rate increase | Investigations | MedDRA (14.0) | Non-systematic Assessment |
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| dizziness | Nervous system disorders | MedDRA (14.0) | Non-systematic Assessment |
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| sedation | Nervous system disorders | MedDRA (14.0) | Non-systematic Assessment |
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| somnolence | Nervous system disorders | MedDRA (14.0) | Non-systematic Assessment |
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| delusion | Psychiatric disorders | MedDRA (14.0) | Non-systematic Assessment |
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| psychotic disorder | Psychiatric disorders | MedDRA (14.0) | Non-systematic Assessment |
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| sleep disorder | Psychiatric disorders | MedDRA (14.0) | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Gerard Lynch | Astra Zeneca | ClinicalTrailTransparency@astrazeneca.com |
| ID | Term |
|---|---|
| D012559 | Schizophrenia |
| ID | Term |
|---|---|
| D019967 | Schizophrenia Spectrum and Other Psychotic Disorders |
| D001523 | Mental Disorders |
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| >50 years |
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| Male |
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| Denmark |
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| Austria |
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| Germany |
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| Italy |
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| Post 3 |
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