Compare the effect on cognitive functioning of two formulations of Seroquel, Seroquel XR and IR in patients with stable schizophrenia - eXtRa

Study identifier:D1443L00082

ClinicalTrials.gov identifier:N/A

EudraCT identifier:2010-020579-21

CTIS identifier:N/A

Study Complete

Official Title

A Phase IV Prospective, Double-blind, Double-dummy, Randomised, Crossover Study to Assess the Impact on Daily Cognitive Functioning of Quetiapine Fumarate Immediate Release (Seroquel IR®) Dosed twice Daily and Quetiapine Fumarate Extended Release (Seroquel XR®) Dosed once Daily in the Evening in Patients with Stable Schizophrenia

Medical condition

schizophrenia

Phase

Phase 4

Healthy volunteers

Study drug

Seroquel XR- quetiapine fumarate extended release, Seroquel IR - quetiapine fumarate, Placebo matching Seroquel XR, Placebo matching Seroquel IR

Sex

All

Actual Enrollment

Study type

Interventional

Age

18 Years - 50 Years

Date

Study Start Date: 01 Nov 2010

Primary Completion Date: 01 Aug 2011

Study Completion Date: 01 Aug 2011

Study design

Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind
Primary Purpose: Treatment

Verification:

Verified 01 May 2012 by AstraZeneca Pharmaceuticals

Collaborators

Inclusion and exclusion criteria

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)

Location

Research Site

WIEN, Austria

Location

Research Site

BERLIN, Germany

Location

Research Site

BOCHUM, Germany

Location

Research Site

HAMBURG, Germany

Location

Research Site

MUNCHEN, Germany

Location

Research Site

ROTTWEIL, Germany

Location

Research Site

GIARRE, CT, Italy

Location

Research Site

GENOVA, GE, Italy

Arms	Assigned Interventions
Active Comparator: 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	Drug: Seroquel 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. Drug: Seroquel 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. Drug: Placebo matching Seroquel XR Placebo matching Seroquel XR dose 400-700 mg (in tablet form). Dose taken once a day for 10-16 days. Drug: Placebo matching Seroquel IR Placebo matching Seroquel IR dose 400-700 mg (in tablet form). Dose taken twice a day for 10-16 days.
Active Comparator: 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	Drug: Seroquel 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. Drug: Seroquel 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. Drug: Placebo matching Seroquel XR Placebo matching Seroquel XR dose 400-700 mg (in tablet form). Dose taken once a day for 10-16 days. Drug: Placebo matching Seroquel IR Placebo matching Seroquel IR dose 400-700 mg (in tablet form). Dose taken twice a day for 10-16 days.

Arms

Assigned Interventions

Active Comparator: 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

Drug: Seroquel 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.

Drug: Seroquel 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.

Drug: Placebo matching Seroquel XR
Placebo matching Seroquel XR dose 400-700 mg (in tablet form). Dose taken once a day for 10-16 days.

Drug: Placebo matching Seroquel IR
Placebo matching Seroquel IR dose 400-700 mg (in tablet form). Dose taken twice a day for 10-16 days.

Active Comparator: 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

Drug: Placebo matching Seroquel XR
Placebo matching Seroquel XR dose 400-700 mg (in tablet form). Dose taken once a day for 10-16 days.

Drug: Placebo matching Seroquel IR
Placebo matching Seroquel IR dose 400-700 mg (in tablet form). Dose taken twice a day for 10-16 days.

Participant Flow

Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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.

Reporting Groups

	Description
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
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

Participant Flow for 2 periods

Period 1: Period 1, First intervention

	First Seroquel XR then Seroquel IR	First Seroquel IR then Seroquel XR
STARTED	34	32
COMPLETED	31	29
NOT COMPLETED	3	3
Adverse Event	2	1
Protocol Violation	0	1
Withdrawal by Subject	1	1

Period 2: Period 2, Second intervention

	First Seroquel XR then Seroquel IR	First Seroquel IR then Seroquel XR
STARTED	31	29
COMPLETED	31	29
NOT COMPLETED	0	0

Baseline Characteristics

Analysis Population Description -- Explanation of how the number of participants for analysis was determined.

Reporting Groups

	Description
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
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

Baseline Measures

	First Seroquel XR then Seroquel IR	First Seroquel IR then Seroquel XR	Total
Number of Participants [units: Participants]	34	32	66
Age Continuous ^[1] [units: participants]
between 18 and 29 years	6	3	9
Between 30 and 50 years	26	28	54
>50 years	2	0	2
Age Continuous ^[2] [units: years] Mean ± Standard Deviation	38.6 ± 8.2	37.0 ± 5.2	37.8 ± 6.9
Gender, Male/Female ^[3] [units: participants]
Female	11	9	20
Male	23	22	45
Region of Enrollment [units: participants]
Spain	1	1	2
Denmark	1	1	2
Austria	1	2	3
Germany	18	10	28
Italy	13	18	31

Outcome Measures

1. Primary Outcome Measure: Mean for Attentional standardised composite score based on performance scores from the CogState Test Battery domains Detection (speed of processing)and Identification (attention/vigilance) [ 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. ]

Measure Type	Primary
Measure Name	Mean for Attentional standardised composite score based on performance scores from the CogState Test Battery domains Detection (speed of processing)and Identification (attention/vigilance)
Measure Description	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.
Safety Issue?	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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.

Reporting Groups

	Description
Seroquel XR	Patients that took Seroquel XR in arm XR-IR and arm IR-XR.
Seroquel IR	Patients that took Seroquel XR in arm XR-IR and arm IR-XR.

Measured Values

	Seroquel XR	Seroquel IR
Number of Participants Analyzed [units:participants]	51	51
Mean for Attentional standardised composite score based on performance scores from the CogState Test Battery domains Detection (speed of processing)and Identification (attention/vigilance) [units: standardised units] Mean (Standard Deviation)
Post 1	0.002 (0.856)	-0.098 (0.983)
Post 2	-0.201 (1.054)	-0.131 (1.053)
Post 3	-0.194 (1.040)	-0.120 (1.100)

No statistical analysis provided for Mean for Attentional standardised composite score based on performance scores from the CogState Test Battery domains Detection (speed of processing)and Identification (attention/vigilance)

2. Secondary Outcome Measure: Mean treatment satisfaction for Treatment Satisfaction Questionnaire of Medication (TSQM) [ Time Frame: Before taking study drug, end of Period 1 and end of Period 2 ]

Measure Type	Secondary
Measure Name	Mean treatment satisfaction for Treatment Satisfaction Questionnaire of Medication (TSQM)
Measure Description	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
Safety Issue?	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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.

Reporting Groups

	Description
Seroquel XR	Patients that took Seroquel XR in arm XR-IR and arm IR-XR.
Seroquel IR	Patients that took Seroquel IR in arm XR-IR and arm IR-XR.

Measured Values

	Seroquel XR	Seroquel IR
Number of Participants Analyzed [units:participants]	60	59
Mean treatment satisfaction for Treatment Satisfaction Questionnaire of Medication (TSQM) [units: units on a scale] Mean (Standard Deviation)
Side Effects	87.9 (20.5)	81.5 (27.5)
Effectiveness	65.4 (16.8)	62.2 (19.1)
Convenience	66.2 (19.3)	63.6 (19.7)
Overall Satisfaction	63.0 (19.7)	58.9 (21.1)

No statistical analysis provided for Mean treatment satisfaction for Treatment Satisfaction Questionnaire of Medication (TSQM)

3. Secondary Outcome Measure: Mean daytime cognitive performance using CogState: - working memory - verbal learning) -reasoning and problem solving [ 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. ]

Measure Type	Secondary
Measure Name	Mean daytime cognitive performance using CogState: - working memory - verbal learning) -reasoning and problem solving
Measure Description	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.
Safety Issue?	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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.

Reporting Groups

	Description
Seroquel XR	Patients that took Seroquel XR in arm XR-IR and arm IR-XR.
Seroquel IR	Patients that took Seroquel IR in arm XR-IR and arm IR-XR.

Measured Values

	Seroquel XR	Seroquel IR
Number of Participants Analyzed [units:participants]	51	51
Mean daytime cognitive performance using CogState: - working memory - verbal learning) -reasoning and problem solving [units: Units on a scale] Mean (Standard Deviation)
ISLT post 1	24.020 (5.746)	23.588 (5.787)
ISLT post 2	23.551 (4.899)	23.152 (5.562)
ISLT post 3	23.216 (5.360)	22.920 (4.944)
GMLT post 1	64.180 (29.822)	61.040 (28.721)
GMLT post 2	59.021 (21.257)	56.956 (21.798)
GMLT post 3	57.229 (24.162)	57.300 (22.307)
ONB post 1	2.875 (0.143)	2.897 (0.134)
ONB post 2	2.896 (0.151)	2.896 (0.169)
ONB post 3	2.894 (0.161)	2.893 (0.154)

No statistical analysis provided for Mean daytime cognitive performance using CogState: - working memory - verbal learning) -reasoning and problem solving

4. Secondary Outcome Measure: Mean overall sedation as measured by the modified Bond-Lader visual analogue scale (VAS) when administered according to label [ 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. ]

Measure Type	Secondary
Measure Name	Mean overall sedation as measured by the modified Bond-Lader visual analogue scale (VAS) when administered according to label
Measure Description	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.
Safety Issue?	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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.

Reporting Groups

	Description
Seroquel XR	Patients that took Seroquel XR in arm XR-IR and arm IR-XR.
Seroquel IR	Patients that took Seroquel IR in arm XR-IR and arm IR-XR.

Measured Values

	Seroquel XR	Seroquel IR
Number of Participants Analyzed [units:participants]	60	60
Mean overall sedation as measured by the modified Bond-Lader visual analogue scale (VAS) when administered according to label [units: units on a scale] Mean (Standard Deviation)	23.5 (19.0)	28.6 (21.4)

No statistical analysis provided for Mean overall sedation as measured by the modified Bond-Lader visual analogue scale (VAS) when administered according to label

5. Secondary Outcome Measure: Mean overall sedation as measured by the Stanford Sleepiness Scale when administered according to label [ 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. ]

Measure Type	Secondary
Measure Name	Mean overall sedation as measured by the Stanford Sleepiness Scale when administered according to label
Measure Description	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.
Safety Issue?	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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.

Reporting Groups

	Description
Seroquel XR	Patients that took Seroquel XR in arm XR-IR and arm IR-XR.
Seroquel IR	Patients that took Seroquel IR in arm XR-IR and arm IR-XR.

Measured Values

	Seroquel XR	Seroquel IR
Number of Participants Analyzed [units:participants]	60	60
Mean overall sedation as measured by the Stanford Sleepiness Scale when administered according to label [units: units on a scale] Mean (Standard Deviation)	2.4 (0.9)	2.6 (1.0)

No statistical analysis provided for Mean overall sedation as measured by the Stanford Sleepiness Scale when administered according to label

6. Secondary Outcome Measure: Number of dropouts. [ Time Frame: Period 1 and Period 2 ]

Measure Type	Secondary
Measure Name	Number of dropouts.
Measure Description	The number of patients who dropped out was counted.
Time Frame	Period 1 and Period 2
Safety Issue?	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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.

Reporting Groups

	Description
Seroquel XR	Patients treated with at least one dose of Seroquel XR
Seroquel IR	Patients treated with at least one dose of Seroquel IR

Measured Values

	Seroquel XR	Seroquel IR
Number of Participants Analyzed [units:participants]	34	31
Number of dropouts. [units: participants]
Period 1	3	2
Period 2	0	0

No statistical analysis provided for Number of dropouts.

7. Secondary Outcome Measure: 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. [ Time Frame: End of Period 1, end of Period 2 ]

Measure Type	Secondary
Measure Name	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.
Measure Description	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
Safety Issue?	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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.

Reporting Groups

	Description
Seroquel XR	Patients that took Seroquel XR in arm XR-IR and arm IR-XR.
Seroquel IR	Patients that took Seroquel IR in arm XR-IR and arm IR-XR.

Measured Values

	Seroquel XR	Seroquel IR
Number of Participants Analyzed [units:participants]	21	21
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. [units: Ratio] Mean (Standard Deviation)	1.941 (1.504)	2.128 (2.369)

No statistical analysis provided for 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.

Serious Adverse Events

Time Frame	No text entered.
Additional Description	No text entered.

Reporting Groups

	Description
Seroquel XR	Patients treated with at least one dose of Seroquel XR
Seroquel IR	Patients treated with at least one dose of Seroquel IR

Serious Adverse Events

	Seroquel XR	Seroquel IR
Total, serious adverse events
# participants affected / at risk	0/63 (0.00%)	0/62 (0.00%)

Other Adverse Events

Time Frame	No text entered.
Additional Description	No text entered.

Frequency Threshold

Threshold above which other adverse events are reported	1%

Reporting Groups

	Description
Seroquel XR	Patients treated with at least one dose of Seroquel XR
Seroquel IR	Patients treated with at least one dose of Seroquel IR