Trial Outcomes & Findings for 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 (NCT NCT01128114)
NCT ID: NCT01128114
Last Updated: 2012-04-17
Results Overview
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.
TERMINATED
PHASE4
32 participants
Baseline, week 4
2012-04-17
Participant Flow
Participant milestones
| Measure |
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
|
|---|---|
|
Overall Study
STARTED
|
32
|
|
Overall Study
COMPLETED
|
24
|
|
Overall Study
NOT COMPLETED
|
8
|
Reasons for withdrawal
| Measure |
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
|
|---|---|
|
Overall Study
Treatment Withdrawn
|
6
|
|
Overall Study
Screening Failed
|
2
|
Baseline Characteristics
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
Baseline characteristics by cohort
| Measure |
Quetiapine XR
n=32 Participants
Extended Release (XR) 50mg, 200mg 300mg and/or 400mg tablet, oral once daily in the evening, from assignment to the end of the study
|
|---|---|
|
Age, Customized
<=18 years
|
0 participants
n=5 Participants
|
|
Age, Customized
Between 18 and 65 years
|
27 participants
n=5 Participants
|
|
Age, Customized
>=65 years
|
0 participants
n=5 Participants
|
|
Age, Customized
Unknown
|
5 participants
n=5 Participants
|
|
Sex/Gender, Customized
Unknown
|
4 participants
n=5 Participants
|
|
Sex/Gender, Customized
Male
|
10 participants
n=5 Participants
|
|
Sex/Gender, Customized
Female
|
18 participants
n=5 Participants
|
|
Region of Enrollment
Korea, Republic of
|
32 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline, week 4Population: As the study was terminated prematurely none of the randomized patients have been analysed.
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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline, week 4The 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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline, week 4The 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
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline, week 4The 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".
Outcome measures
Outcome data not reported
Adverse Events
Quetiapine XR
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place