Seroquel XR in adults with schizophrenia

Study identifier:D1443L00060

ClinicalTrials.gov identifier:N/A

EudraCT identifier:N/A

CTIS identifier:N/A

Terminated/Withdrawn

Official Title

Open-label multicentre study on efficacy and safety of oral quetiapine (Seroquel XR) in adults with schizophrenia

Medical condition

schizophrenia

Phase

Phase 3

Healthy volunteers

Yes

Study drug

Quetiapine fumarate (Seroquel)

Sex

All

Actual Enrollment

Study type

Interventional

Age

18 Years - 65 Years

Date

Study Start Date: 01 Feb 2009

Primary Completion Date: 01 May 2010

Study Completion Date: 01 May 2010

Study design

Allocation: N/A
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Verification:

Verified 01 May 2012 by AstraZeneca Pharmaceuticals

Collaborators

Inclusion and exclusion criteria

No locations available

Arms	Assigned Interventions

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 provide informed consent and are screened for eligibility (at Visit 1) up to 7 days before baseline assessment on Day 1.

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
On Day 1, baseline assessments will be performed, and patients will be assigned to Seroquel XR at 300 mg. On Day 2 all patients are assigned to reach target dose of Seroquel XR at 600 mg. Administration of study medication continue with Seroquel XR 600 mg daily until Day 42. Each visit will have ± 3 days window period.

Reporting Groups

	Description
Seroquel XR	Seroquel XR 300mg on day 1, 600mg from day 2 onwards. The treatment period will take 6 weeks or 42 days.

Participant Flow: Overall Study

	Seroquel XR
STARTED	28
COMPLETED	17
NOT COMPLETED	11

Baseline Characteristics

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

Reporting Groups

	Description
Seroquel XR	Seroquel XR 300mg on day 1, 600mg from day 2 onwards. The treatment period will take 6 weeks or 42 days.

Baseline Measures

	Seroquel XR
Number of Participants [units: Participants]	28
Age Continuous [units: Years] Median ± Standard Deviation	43 ± 39.5
Gender, Male/Female [units: participants]
Female	8
Male	20

Outcome Measures

1. Primary Outcome Measure: Change in positive and Negative Syndrome Scale (PANSS) total score [ Time Frame: From Day 1 (baseline) to Day 42 ]

Measure Type	Primary
Measure Name	Change in positive and Negative Syndrome Scale (PANSS) total score
Measure Description	Change in Positive and Negative Syndrome Scale Total Score from Day 1 (baseline) to Day 42 (final visit) or withdrawal. Minimum value of total PANSS is 30 , Maximum is 210. Minimum value considered better is score decreased from baseline at least 30%.
Time Frame	From Day 1 (baseline) to Day 42
Safety Issue?	Yes

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 number of patient at Day 42 (n= 17) is different than at Baseline (n= 28), because some of them withdraw/terminate during the study.

Reporting Groups

	Description
Seroquel XR	Seroquel XR 300mg on day 1, 600mg from day 2 onwards. The treatment period will take 6 weeks or 42 days.

Measured Values

	Seroquel XR
Number of Participants Analyzed [units:participants]	28
Change in positive and Negative Syndrome Scale (PANSS) total score [units: Scores on a scale] Mean (Standard Deviation)
Day 1 (Baseline) (n= 28)	85.3 (28.8)
Day 42 (n= 17)	48.5 (28.6)

No statistical analysis provided for Change in positive and Negative Syndrome Scale (PANSS) total score

2. Secondary Outcome Measure: Change in Clinical Global Impression - Severity of Illness (CGI-S) score [ Time Frame: From Day 1 (Baseline) to Day 42 ]

Measure Type	Secondary
Measure Name	Change in Clinical Global Impression - Severity of Illness (CGI-S) score
Measure Description	Clinical Global Impression - Severity of Illness. Maximum possible value is 7 (worst outcome), the minimum is 1 (best outcome). Values are considered better outcome: decrease from baseline > 1 score.
Time Frame	From Day 1 (Baseline) to Day 42
Safety Issue?	Yes

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 number of patient at Day 42 (n= 17) is different than at Baseline (n= 28), because some of them withdraw/terminate during the study.

Reporting Groups

	Description
Seroquel XR	Seroquel XR 300mg on day 1, 600mg from day 2 onwards. The treatment period will take 6 weeks or 42 days.

Measured Values

	Seroquel XR
Number of Participants Analyzed [units:participants]	28
Change in Clinical Global Impression - Severity of Illness (CGI-S) score [units: Scores on a scale] Mean (Standard Deviation)
Day 1 (Baseline) (n= 28)	4.6 (0.7)
Day 42 (n= 17)	2.7 (1.1)

No statistical analysis provided for Change in Clinical Global Impression - Severity of Illness (CGI-S) score

3. Secondary Outcome Measure: Clinical Global Impression - Severity of Illness (CGI-S) score [ Time Frame: Day 14 ]

Measure Type	Secondary
Measure Name	Clinical Global Impression - Severity of Illness (CGI-S) score
Measure Description	Clinical Global Impression - Severity of Illness. Maximum possible value is 7 (worst outcome), the minimum is 1 (best outcome). Values are considered better outcome: decrease from baseline > 1 score.
Time Frame	Day 14
Safety Issue?	Yes

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 number of patient is different, because some of them withdraw/terminate during the study.

Reporting Groups

	Description
Seroquel XR	Seroquel XR 300mg on day 1, 600mg from day 2 onwards. The treatment period will take 6 weeks or 42 days.

Measured Values

	Seroquel XR
Number of Participants Analyzed [units:participants]	21
Clinical Global Impression - Severity of Illness (CGI-S) score [units: Scores on a scale] Mean (Standard Deviation)	3.2 (1.1)

No statistical analysis provided for Clinical Global Impression - Severity of Illness (CGI-S) score

Serious Adverse Events

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

Reporting Groups

	Description
Seroquel XR	Seroquel XR 300mg on day 1, 600mg from day 2 onwards. The treatment period will take 6 weeks or 42 days.

Serious Adverse Events

Seroquel XR

Total, serious adverse events

# participants affected / at risk

1/28 (3.57%)

Nervous system disorders

Seizure

# participants affected / at risk

1/28 (3.57%)

†	Events were collected by systematic assessment
1	Term from vocabulary,

Other Adverse Events

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

Frequency Threshold

Threshold above which other adverse events are reported	5%

Reporting Groups

	Description
Seroquel XR	Seroquel XR 300mg on day 1, 600mg from day 2 onwards. The treatment period will take 6 weeks or 42 days.

Other Adverse Events

Seroquel XR

Total, other (not including serious) adverse events

# participants affected / at risk

14/28 (50.00%)

Gastrointestinal disorders

Dry Mouth

# participants affected / at risk

2/28 (7.14%)

Gastrointestinal disorders

Constipation

# participants affected / at risk

3/28 (10.71%)

Nervous system disorders

Dizziness

# participants affected / at risk

2/28 (7.14%)

Nervous system disorders

Headache

# participants affected / at risk

2/28 (7.14%)

Vascular disorders

Hypotension

# participants affected / at risk

3/28 (10.71%)

Respiratory, thoracic and mediastinal disorders

Stiff nose

# participants affected / at risk

2/28 (7.14%)

†	Events were collected by systematic assessment
1	Term from vocabulary,

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.

Results Point of Contact

Name/Title:	Gerard Lynch
Organization:	AstraZeneca
E-mail:	[email protected]

Documents available

https://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_MED_6111&studyid=269&filename=CSR-D1443L00060.pdf
Download
CSR-D1443L00060.pdf
Download
Trial Results Summaries
Available here

Contacts

Contact

AstraZeneca Thainland Study Information

66-2-7397400

sasarose.rochanaruangrai@astrazeneca.com

Investigators

Principal Investigator

Thawatchai Leelahanaj

Phramongkutklao Hospital, Bangkok, Thailand

Sponsors

Collaborators

Inclusion Criteria

Exclusion Criteria

https://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_MED_6111&studyid=269&filename=CSR-D1443L00060.pdf

CSR-D1443L00060.pdf

Trial Results Summaries