Schizophrenia
Conditions
Keywords
Stable schizophrenia, cognitive functioning
Brief summary
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.
Interventions
DRUGSeroquel XR- quetiapine fumarate extended release
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.
DRUGSeroquel IR - quetiapine fumarate
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.
DRUGPlacebo matching Seroquel XR
Placebo matching Seroquel XR dose 400-700 mg (in tablet form). Dose taken once a day for 10-16 days.
DRUGPlacebo matching Seroquel IR
Placebo matching Seroquel IR dose 400-700 mg (in tablet form). Dose taken twice a day for 10-16 days.
Sponsors
AstraZeneca
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
No
Inclusion criteria
* Provision of written informed consent prior to any study specific procedures * Documented clinical diagnosis of schizophrenia, paranoid type, for at least 2 years before randomisation meeting the Diagnostic and Statistical Manual of Mental Disorders, 4th Edition (DSM-IV, American Psychiatric Association 2000) criteria of schizophrenia (DSM-IV codes 295.3) confirmed by MINI version 5.0 * Outpatient status at enrolment * Dose of quetiapine IR or quetiapine XR unchanged during the last 56 days before randomisation
Exclusion criteria
* Diagnosis of any DSM-IV Axis I disorder other than those included in inclusion criteria above within 6 months before randomisation (e.g., alcohol dependence or psychoactive substance dependence not in full remission, concurrent organic mental disorder, or mental retardation \[axis II diagnosis\]) of a degree that may interfere with the patient's ability to co-operate. * Previous stable use of high dosage of benzodiazepines during one year or more * Significant neurological medical history (complicated head trauma as judged by the investigator, epilepsy, meningo-encephalitis) * Use of the following medication: * other antipsychotic drug than quetiapine within 28 days prior to randomisation * a depot antipsychotic injection within two dosing intervals (for the depot) before randomisation (Visit 2) * other psychoactive drugs within 14 days prior to randomisation (hypnotic or anxiolytic drugs, other than those allowed) * Use of concomitant therapy likely to affect cognition, Medication prohibited 28 days prior to randomisation: benzodiazepines, amphetamines, reboxitin, atomoxinetine, buspiron, donepezil, duloxetine, galantamine, ginko biloba, memantine, methylphenidate, modafinil, rivastigmine, tacrine, smoking cessation therapy varencicline and any dosage form of nicotine replacement therapy. Medication prohibited 14 days prior to randomisation: irreversible monoamine oxidase inhibitors (MAOI), tricyclic antidepressants (TCA), biperiden, antoicholinergic agents (even if the indications are extra pyramidal symptoms or urinary symptoms)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean for Attentional Standardised Composite Score Based on Performance Scores From the CogState Test Battery Domains Detection (Speed of Processing)and Identification (Attention/Vigilance) | 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. | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mean Daytime Cognitive Performance Using CogState: - Working Memory - Verbal Learning) -Reasoning and Problem Solving | 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. | 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. |
| Mean Overall Sedation as Measured by the Modified Bond-Lader Visual Analogue Scale (VAS) When Administered According to Label | 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. | 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. |
| Mean Treatment Satisfaction for Treatment Satisfaction Questionnaire of Medication (TSQM) | Before taking study drug, end of Period 1 and end of Period 2 | 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. |
| Number of Dropouts. | Period 1 and Period 2 | The number of patients who dropped out was counted. |
| 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. | End of Period 1, end of Period 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. |
| Mean Overall Sedation as Measured by the Stanford Sleepiness Scale When Administered According to Label | 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. | 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. |
Countries
Austria, Denmark, Germany, Italy, Spain
Participant flow
Recruitment details
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.
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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 | 34 |
| 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 | 32 |
| Total | 66 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Period 1, First Intervention | Adverse Event | 2 | 1 |
| Period 1, First Intervention | Protocol Violation | 0 | 1 |
| Period 1, First Intervention | Withdrawal by Subject | 1 | 1 |
Baseline characteristics
| Characteristic | Total | First Seroquel IR Then Seroquel XR | First Seroquel XR Then Seroquel IR |
|---|---|---|---|
| Age Continuous >50 years | 2 participants | 0 participants | 2 participants |
| Age Continuous between 18 and 29 years | 9 participants | 3 participants | 6 participants |
| Age Continuous Between 30 and 50 years | 54 participants | 28 participants | 26 participants |
| Age Continuous | 37.8 years STANDARD_DEVIATION 6.9 | 37.0 years STANDARD_DEVIATION 5.2 | 38.6 years STANDARD_DEVIATION 8.2 |
| Gender Female | 20 participants | 9 participants | 11 participants |
| Gender Male | 45 participants | 22 participants | 23 participants |
| Region of Enrollment Austria | 3 participants | 2 participants | 1 participants |
| Region of Enrollment Denmark | 2 participants | 1 participants | 1 participants |
| Region of Enrollment Germany | 28 participants | 10 participants | 18 participants |
| Region of Enrollment Italy | 31 participants | 18 participants | 13 participants |
| Region of Enrollment Spain | 2 participants | 1 participants | 1 participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 4 / 63 | 4 / 62 |
| serious Total, serious adverse events | 0 / 63 | 0 / 62 |
Outcome results
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.
Time frame: 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.
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Seroquel XR | Mean for Attentional Standardised Composite Score Based on Performance Scores From the CogState Test Battery Domains Detection (Speed of Processing)and Identification (Attention/Vigilance) | Post 1 | 0.002 standardised units | Standard Deviation 0.856 |
| Seroquel XR | Mean for Attentional Standardised Composite Score Based on Performance Scores From the CogState Test Battery Domains Detection (Speed of Processing)and Identification (Attention/Vigilance) | Post 2 | -0.201 standardised units | Standard Deviation 1.054 |
| Seroquel XR | Mean for Attentional Standardised Composite Score Based on Performance Scores From the CogState Test Battery Domains Detection (Speed of Processing)and Identification (Attention/Vigilance) | Post 3 | -0.194 standardised units | Standard Deviation 1.04 |
| Seroquel IR | Mean for Attentional Standardised Composite Score Based on Performance Scores From the CogState Test Battery Domains Detection (Speed of Processing)and Identification (Attention/Vigilance) | Post 1 | -0.098 standardised units | Standard Deviation 0.983 |
| Seroquel IR | Mean for Attentional Standardised Composite Score Based on Performance Scores From the CogState Test Battery Domains Detection (Speed of Processing)and Identification (Attention/Vigilance) | Post 2 | -0.131 standardised units | Standard Deviation 1.053 |
| Seroquel IR | Mean for Attentional Standardised Composite Score Based on Performance Scores From the CogState Test Battery Domains Detection (Speed of Processing)and Identification (Attention/Vigilance) | Post 3 | -0.120 standardised units | Standard Deviation 1.1 |
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.
Time frame: 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.
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Seroquel XR | Mean Daytime Cognitive Performance Using CogState: - Working Memory - Verbal Learning) -Reasoning and Problem Solving | ISLT post 2 | 23.551 Units on a scale | Standard Deviation 4.899 |
| Seroquel XR | Mean Daytime Cognitive Performance Using CogState: - Working Memory - Verbal Learning) -Reasoning and Problem Solving | GMLT post 3 | 57.229 Units on a scale | Standard Deviation 24.162 |
| Seroquel XR | Mean Daytime Cognitive Performance Using CogState: - Working Memory - Verbal Learning) -Reasoning and Problem Solving | GMLT post 1 | 64.180 Units on a scale | Standard Deviation 29.822 |
| Seroquel XR | Mean Daytime Cognitive Performance Using CogState: - Working Memory - Verbal Learning) -Reasoning and Problem Solving | ONB post 1 | 2.875 Units on a scale | Standard Deviation 0.143 |
| Seroquel XR | Mean Daytime Cognitive Performance Using CogState: - Working Memory - Verbal Learning) -Reasoning and Problem Solving | ISLT post 3 | 23.216 Units on a scale | Standard Deviation 5.36 |
| Seroquel XR | Mean Daytime Cognitive Performance Using CogState: - Working Memory - Verbal Learning) -Reasoning and Problem Solving | ONB post 2 | 2.896 Units on a scale | Standard Deviation 0.151 |
| Seroquel XR | Mean Daytime Cognitive Performance Using CogState: - Working Memory - Verbal Learning) -Reasoning and Problem Solving | GMLT post 2 | 59.021 Units on a scale | Standard Deviation 21.257 |
| Seroquel XR | Mean Daytime Cognitive Performance Using CogState: - Working Memory - Verbal Learning) -Reasoning and Problem Solving | ONB post 3 | 2.894 Units on a scale | Standard Deviation 0.161 |
| Seroquel XR | Mean Daytime Cognitive Performance Using CogState: - Working Memory - Verbal Learning) -Reasoning and Problem Solving | ISLT post 1 | 24.020 Units on a scale | Standard Deviation 5.746 |
| Seroquel IR | Mean Daytime Cognitive Performance Using CogState: - Working Memory - Verbal Learning) -Reasoning and Problem Solving | ONB post 3 | 2.893 Units on a scale | Standard Deviation 0.154 |
| Seroquel IR | Mean Daytime Cognitive Performance Using CogState: - Working Memory - Verbal Learning) -Reasoning and Problem Solving | ISLT post 1 | 23.588 Units on a scale | Standard Deviation 5.787 |
| Seroquel IR | Mean Daytime Cognitive Performance Using CogState: - Working Memory - Verbal Learning) -Reasoning and Problem Solving | ISLT post 2 | 23.152 Units on a scale | Standard Deviation 5.562 |
| Seroquel IR | Mean Daytime Cognitive Performance Using CogState: - Working Memory - Verbal Learning) -Reasoning and Problem Solving | ISLT post 3 | 22.920 Units on a scale | Standard Deviation 4.944 |
| Seroquel IR | Mean Daytime Cognitive Performance Using CogState: - Working Memory - Verbal Learning) -Reasoning and Problem Solving | GMLT post 1 | 61.040 Units on a scale | Standard Deviation 28.721 |
| Seroquel IR | Mean Daytime Cognitive Performance Using CogState: - Working Memory - Verbal Learning) -Reasoning and Problem Solving | GMLT post 2 | 56.956 Units on a scale | Standard Deviation 21.798 |
| Seroquel IR | Mean Daytime Cognitive Performance Using CogState: - Working Memory - Verbal Learning) -Reasoning and Problem Solving | GMLT post 3 | 57.300 Units on a scale | Standard Deviation 22.307 |
| Seroquel IR | Mean Daytime Cognitive Performance Using CogState: - Working Memory - Verbal Learning) -Reasoning and Problem Solving | ONB post 1 | 2.897 Units on a scale | Standard Deviation 0.134 |
| Seroquel IR | Mean Daytime Cognitive Performance Using CogState: - Working Memory - Verbal Learning) -Reasoning and Problem Solving | ONB post 2 | 2.896 Units on a scale | Standard Deviation 0.169 |
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.
Time frame: 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.
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Seroquel XR | Mean Overall Sedation as Measured by the Modified Bond-Lader Visual Analogue Scale (VAS) When Administered According to Label | 23.5 units on a scale | Standard Deviation 19 |
| Seroquel IR | Mean Overall Sedation as Measured by the Modified Bond-Lader Visual Analogue Scale (VAS) When Administered According to Label | 28.6 units on a scale | Standard Deviation 21.4 |
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.
Time frame: 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.
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Seroquel XR | Mean Overall Sedation as Measured by the Stanford Sleepiness Scale When Administered According to Label | 2.4 units on a scale | Standard Deviation 0.9 |
| Seroquel IR | Mean Overall Sedation as Measured by the Stanford Sleepiness Scale When Administered According to Label | 2.6 units on a scale | Standard Deviation 1 |
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.
Time frame: End of Period 1, end of Period 2
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Seroquel XR | 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. | 1.941 Ratio | Standard Deviation 1.504 |
| Seroquel IR | 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. | 2.128 Ratio | Standard Deviation 2.369 |
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.
Time frame: Before taking study drug, end of Period 1 and end of Period 2
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Seroquel XR | Mean Treatment Satisfaction for Treatment Satisfaction Questionnaire of Medication (TSQM) | Side Effects | 87.9 units on a scale | Standard Deviation 20.5 |
| Seroquel XR | Mean Treatment Satisfaction for Treatment Satisfaction Questionnaire of Medication (TSQM) | Effectiveness | 65.4 units on a scale | Standard Deviation 16.8 |
| Seroquel XR | Mean Treatment Satisfaction for Treatment Satisfaction Questionnaire of Medication (TSQM) | Convenience | 66.2 units on a scale | Standard Deviation 19.3 |
| Seroquel XR | Mean Treatment Satisfaction for Treatment Satisfaction Questionnaire of Medication (TSQM) | Overall Satisfaction | 63.0 units on a scale | Standard Deviation 19.7 |
| Seroquel IR | Mean Treatment Satisfaction for Treatment Satisfaction Questionnaire of Medication (TSQM) | Overall Satisfaction | 58.9 units on a scale | Standard Deviation 21.1 |
| Seroquel IR | Mean Treatment Satisfaction for Treatment Satisfaction Questionnaire of Medication (TSQM) | Side Effects | 81.5 units on a scale | Standard Deviation 27.5 |
| Seroquel IR | Mean Treatment Satisfaction for Treatment Satisfaction Questionnaire of Medication (TSQM) | Convenience | 63.6 units on a scale | Standard Deviation 19.7 |
| Seroquel IR | Mean Treatment Satisfaction for Treatment Satisfaction Questionnaire of Medication (TSQM) | Effectiveness | 62.2 units on a scale | Standard Deviation 19.1 |
Secondary
Number of Dropouts.
The number of patients who dropped out was counted.
Time frame: Period 1 and Period 2
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Seroquel XR | Number of Dropouts. | Period 1 | 3 participants |
| Seroquel XR | Number of Dropouts. | Period 2 | 0 participants |
| Seroquel IR | Number of Dropouts. | Period 1 | 2 participants |
| Seroquel IR | Number of Dropouts. | Period 2 | 0 participants |