Study of the Broad Clinical Benefit for Seroquel XR with flexible dose as an add-on therapy in the Treatment of Acute Bipolar Mania patients with Partial Response to Current Therapy - RELEASE

Study identifier:D1443L00080

ClinicalTrials.gov identifier:N/A

EudraCT identifier:N/A

CTIS identifier:N/A

Terminated/Withdrawn

Official Title

A 4-week, Multi-Centre, Open-label, Non-comparative, Phase IV Study of the Broad Clinical Benefit for Seroquel XR (Quetiapine Fumarate extended release) with flexible dose as an add-on therapy in the Treatment of Acute Bipolar Mania patients with Partial Response to Current Therapy

Medical condition

Acute bipolar mania

Phase

Phase 4

Healthy volunteers

Study drug

Quetiapine fumarate (Seroquel XR)

Sex

All

Actual Enrollment

Study type

Interventional

Age

18 Years - 65 Years

Date

Study Start Date: 01 Jun 2010

Primary Completion Date: 01 Mar 2011

Study Completion Date: 01 Mar 2011

Study design

Allocation: None
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Verification:

Verified 01 Apr 2012 by AstraZeneca

Collaborators

Inclusion and exclusion criteria

Location

Research Site

BUCHEON, GUEONGGIDO, Republic of Korea

Location

Research Site

CHUNAN, CHOONGNAM, Republic of Korea

Location

Research Site

CHUNCHEON, GANGWONDO, Republic of Korea

Location

Research Site

DAEJEON, Republic of Korea

Location

Research Site

GYUNGBOOK, Republic of Korea

Location

Research Site

NAJU, Republic of Korea

Location

Research Site

SEOUL, Republic of Korea

Location

Research Site

SUWON, Gyeonggi-do, Republic of Korea

Arms	Assigned Interventions
Experimental: Quetiapine XR Quetiapine fumarate (Seroquel XR)	Drug: Quetiapine fumarate (Seroquel XR) Extended Release(XR) 50 mg, 200 mg, 300 mg and/or 400 mg tablet, oral, once daily in the evening, from assignment to the end of the study. Other Name: Seroquel XR tablet

Participant Flow

Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups

	Description
Quetiapine XR	Extended Release (XR) 50mg, 200mg 300mg and/or 400mg tablet, oral once daily in the evening, from assignment to the end of the study

Participant Flow: Overall Study

	Quetiapine XR
STARTED	32
COMPLETED	24
NOT COMPLETED	8
Treatment Withdrawn	6
Screening Failed	2

Baseline Characteristics

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

Reporting Groups

	Description
Quetiapine XR	Extended Release (XR) 50mg, 200mg 300mg and/or 400mg tablet, oral once daily in the evening, from assignment to the end of the study

Baseline Measures

	Quetiapine XR
Number of Participants [units: Participants]	32
Age, Customized [units: participants]
<=18 years	0
Between 18 and 65 years	27
>=65 years	0
Unknown	5
Gender, Customized [units: participants]
Unknown	4
Male	10
Female	18
Region of Enrollment [units: participants]	32

Outcome Measures

1. Primary Outcome Measure: The proportion of patients with improvement from baseline to week 4 in Clinical Global Impression-Clinical Benefit score (LOCF) [ Time Frame: Baseline, week 4 ]

Measure Type	Primary
Measure Name	The proportion of patients with improvement from baseline to week 4 in Clinical Global Impression-Clinical Benefit score (LOCF)
Measure Description	CGI-CB is used to evaluate the investigator's global weighted impression of efficacy and interference of adverse event from baseline to every visit. Improvement in clinical benefit is defined as a decrease from baseline in CGI-CB. Rank 1 denotes best possible benefit from new treatment and rank 10 indicates that there is no benefit from treatment.
Time Frame	Baseline, week 4
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.
As the study was terminated prematurely none of the randomized patients have been analysed.

Reporting Groups

	Description
Quetiapine XR	Extended Release (XR) 50mg, 200mg 300mg and/or 400mg tablet, oral once daily in the evening, from assignment to the end of the study

Measured Values

	Quetiapine XR
Number of Participants Analyzed [units:participants]	0
The proportion of patients with improvement from baseline to week 4 in Clinical Global Impression-Clinical Benefit score (LOCF) [units: Participants]

No statistical analysis provided for The proportion of patients with improvement from baseline to week 4 in Clinical Global Impression-Clinical Benefit score (LOCF)

2. Secondary Outcome Measure: The mean change from baseline to week 4 in - YMRS (Young Mania Rating Scale) total score [ Time Frame: Baseline, week 4 ]

Measure Type	Secondary
Measure Name	The mean change from baseline to week 4 in - YMRS (Young Mania Rating Scale) total score
Measure Description	The YMRS is an 11-item, multiple-choice diagnostic questionnaire which psychiatrists use to measure severity of manic episodes. There are 4 items graded on a 0 to 8 scale (irritability, speech, thought content, disruptive/aggressive behavior), and 7 items graded on 0 to 4 scale. These 4 items are given twice the weight of the others to compensate for poor cooperation from severely ill patients. Typical YMRS baseline scores can vary a lot. They depend on patients’ clinical features such as mania (YMRS = 12), depression (YMRS = 3), or euthymia (YMRS = 2.
Time Frame	Baseline, week 4
Safety Issue?	No

Results not yet posted. Anticipated Posting Date: No text entered. Safety Issue: No

3. Secondary Outcome Measure: The CGI-I (Clinical Global Impression-Improvement of Illness) change from baseline to week 4 [ Time Frame: Baseline, week 4 ]

Measure Type	Secondary
Measure Name	The CGI-I (Clinical Global Impression-Improvement of Illness) change from baseline to week 4
Measure Description	The Global Improvement scale (CGI-I) is scored to rate the patient’s change from baseline CGI. A CGI-I score of 1 indicates that a patient is “very much improved” and a score of 7 indicates that a patient is “very much worse.” CGI-I scores greater than 4 indicate worsening, while scores less than 4 indicate improvement. At all following visits CGI-I will also be rated. The following calculations will be made: Proportion of patients with CGI Global Improvement rating ≤ 2 at Day 29
Time Frame	Baseline, week 4
Safety Issue?	No

Results not yet posted. Anticipated Posting Date: No text entered. Safety Issue: No

4. Secondary Outcome Measure: The mean change from baseline to week 4 in CGI-S (Clinical Global Impression-Severity of Illness) score [ Time Frame: Baseline, week 4 ]

Measure Type	Secondary
Measure Name	The mean change from baseline to week 4 in CGI-S (Clinical Global Impression-Severity of Illness) score
Measure Description	The CGI-S is scored to rate patient’s current clinical state. At enrolment patient’s condition is rated using the CGI-S. At assignment CGI-S is again completed and a score of at least 4 (moderately ill). The score at assignment Day 1 will be regarded as the baseline value. At all following visits CGI-S will be rated. Each CGI item is scored on a scale from 1 to 7. A CGI-S score of 1 indicates that a patient is “Normal, not at all ill” and a score of 7 indicates that a patient is “Among the most extremely ill patients”.
Time Frame	Baseline, week 4
Safety Issue?	No

Results not yet posted. Anticipated Posting Date: No text entered. Safety Issue: No

Serious Adverse Events

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

Reporting Groups

	Description
Quetiapine XR	Extended Release (XR) 50mg, 200mg 300mg and/or 400mg tablet, oral once daily in the evening, from assignment to the end of the study

Serious Adverse Events

	Quetiapine XR
Total, serious adverse events
# participants affected / at risk	0/32 (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	5%

Reporting Groups

	Description
Quetiapine XR	Extended Release (XR) 50mg, 200mg 300mg and/or 400mg tablet, oral once daily in the evening, from assignment to the end of the study

Other Adverse Events

	Quetiapine XR
Total, other (not including serious) adverse events
# participants affected / at risk	0/32 (0.00%)

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
In March 2011, considering the low patient inclusion rate (32 patients recruited so far whereas study objective was 125 patients for 85 completers), the study was ended prematurely earlier than the planned date. No analysis was conducted afterwards.

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=272&filename=CSR-D1443L00080.pdf
Download
CSR-D1443L00080.pdf
Download
Trial Results Summaries
Available here

Contacts

Contact

AstraZeneca Korea Study Information

82-2-2188-0948

taesik.choi@astrazeneca.com

Investigators

Principal Investigator

Joon Woo Bahn

AstraZeneca

Sponsors

Collaborators

Inclusion Criteria

Exclusion Criteria

Research Site

Research Site

Research Site

Research Site

Research Site

Research Site

Research Site

Research Site

https://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_MED_6111&studyid=272&filename=CSR-D1443L00080.pdf

CSR-D1443L00080.pdf

Trial Results Summaries