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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)

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ClinicalTrials.gov Identifier: NCT01128114
Recruitment Status : Terminated (Poor recruitment)
First Posted : May 21, 2010
Results First Posted : April 10, 2012
Last Update Posted : April 17, 2012
Sponsor:
Information provided by (Responsible Party):
AstraZeneca

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Acute Bipolar Mania
Intervention Drug: Quetiapine fumarate (Seroquel XR)
Enrollment 32
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Quetiapine XR
Hide Arm/Group Description Extended Release (XR) 50mg, 200mg 300mg and/or 400mg tablet, oral once daily in the evening, from assignment to the end of the study
Period Title: Overall Study
Started 32
Completed 24
Not Completed 8
Reason Not Completed
Treatment Withdrawn             6
Screening Failed             2
Arm/Group Title Quetiapine XR
Hide Arm/Group Description Extended Release (XR) 50mg, 200mg 300mg and/or 400mg tablet, oral once daily in the evening, from assignment to the end of the study
Overall Number of Baseline Participants 32
Hide Baseline Analysis Population Description
[Not Specified]
Age, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 32 participants
<=18 years 0
Between 18 and 65 years 27
>=65 years 0
Unknown 5
Sex/Gender, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 32 participants
Unknown 4
Male 10
Female 18
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Korea, Republic of Number Analyzed 32 participants
32
1.Primary Outcome
Title The Proportion of Patients With Improvement From Baseline to Week 4 in Clinical Global Impression-Clinical Benefit Score (LOCF)
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
As the study was terminated prematurely none of the randomized patients have been analysed.
Arm/Group Title Quetiapine XR
Hide Arm/Group Description:
Extended Release (XR) 50mg, 200mg 300mg and/or 400mg tablet, oral once daily in the evening, from assignment to the end of the study
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
2.Secondary Outcome
Title The Mean Change From Baseline to Week 4 in - YMRS (Young Mania Rating Scale) Total Score
Hide 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
Outcome Measure Data Not Reported
3.Secondary Outcome
Title The CGI-I (Clinical Global Impression-Improvement of Illness) Change From Baseline to Week 4
Hide 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
Outcome Measure Data Not Reported
4.Secondary Outcome
Title The Mean Change From Baseline to Week 4 in CGI-S (Clinical Global Impression-Severity of Illness) Score
Hide 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
Outcome Measure Data Not Reported
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Quetiapine XR
Hide Arm/Group Description Extended Release (XR) 50mg, 200mg 300mg and/or 400mg tablet, oral once daily in the evening, from assignment to the end of the study
All-Cause Mortality
Quetiapine XR
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Quetiapine XR
Affected / at Risk (%)
Total   0/32 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Quetiapine XR
Affected / at Risk (%)
Total   0/32 (0.00%) 
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.
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.
Results Point of Contact
Name/Title: Gerard Lynch
Organization: AstraZeneca
Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT01128114     History of Changes
Other Study ID Numbers: D1443L00080
First Submitted: May 20, 2010
First Posted: May 21, 2010
Results First Submitted: May 24, 2011
Results First Posted: April 10, 2012
Last Update Posted: April 17, 2012