Trial Outcomes & Findings for Study of the Efficacy and Safety of Quetiapine Fumarate Extended Release (Seroquel XR) (NCT NCT00779506)
NCT ID: NCT00779506
Last Updated: 2011-11-23
Results Overview
PANSS, a 30-item scale where each symptom is rated on a severity scale ranging from 1 (absent) - 7 (extreme), total score is 30 - 210. Description of the reporting Groups: Evaluate the efficacy of Quetiapine XR with daily dose 400 mg - 800 mg used as mono-therapy in the treatment of acute schizophrenic patients by evaluation of the change from baseline to Day 57 in total score of PANSS using the last observation carried forward (LOCF) method
COMPLETED
PHASE4
96 participants
From baseline to Day 57
2011-11-23
Participant Flow
From 4 Nov 2008 to 9 July 2009, 96 subjects were enrolled from 9 centers in Korea
Participant milestones
| Measure |
Quetiapine XR
This is an 8-week, multi-centre, open-label, non-comparative study to evaluate the efficacy and safety of Quetiapine XR with daily dose 400mg-800mg used as mono-therapy in the treatment of acute schizophrenic patients
|
|---|---|
|
Overall Study
STARTED
|
96
|
|
Overall Study
Enrolled
|
96
|
|
Overall Study
Screen Failed
|
2
|
|
Overall Study
Assigned
|
94
|
|
Overall Study
MITT
|
89
|
|
Overall Study
Treatment Complete
|
67
|
|
Overall Study
Withdrawal Treatment
|
27
|
|
Overall Study
COMPLETED
|
67
|
|
Overall Study
NOT COMPLETED
|
29
|
Reasons for withdrawal
| Measure |
Quetiapine XR
This is an 8-week, multi-centre, open-label, non-comparative study to evaluate the efficacy and safety of Quetiapine XR with daily dose 400mg-800mg used as mono-therapy in the treatment of acute schizophrenic patients
|
|---|---|
|
Overall Study
Screening Failed
|
2
|
|
Overall Study
Adverse Event
|
4
|
|
Overall Study
Lack of Efficacy
|
11
|
|
Overall Study
Protocol Violation
|
5
|
|
Overall Study
Withdrawal by Subject
|
6
|
|
Overall Study
Lost to Follow-up
|
1
|
Baseline Characteristics
Study of the Efficacy and Safety of Quetiapine Fumarate Extended Release (Seroquel XR)
Baseline characteristics by cohort
| Measure |
Quetiapine XR
n=89 Participants
This is an 8-week, multi-centre, open-label, non-comparative study to evaluate the efficacy and safety of Quetiapine XR with daily dose 400mg-800mg used as mono-therapy in the treatment of acute schizophrenic patients
|
|---|---|
|
Age Continuous
Female
|
35.8 Years
STANDARD_DEVIATION 13 • n=5 Participants
|
|
Age Continuous
Male
|
42.4 Years
STANDARD_DEVIATION 9.8 • n=5 Participants
|
|
Age Continuous
Total
|
39.7 Years
STANDARD_DEVIATION 11.6 • n=5 Participants
|
|
Sex: Female, Male
Female
|
37 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
52 Participants
n=5 Participants
|
|
BMI
Female
|
23.7 kg/m2
STANDARD_DEVIATION 5.4 • n=5 Participants
|
|
BMI
Male
|
23.4 kg/m2
STANDARD_DEVIATION 3.5 • n=5 Participants
|
|
BMI
Total
|
23.5 kg/m2
STANDARD_DEVIATION 4.4 • n=5 Participants
|
|
Height
Female
|
158 cm
STANDARD_DEVIATION 5.9 • n=5 Participants
|
|
Height
Male
|
168.7 cm
STANDARD_DEVIATION 6.6 • n=5 Participants
|
|
Height
Total
|
164.2 cm
STANDARD_DEVIATION 8.2 • n=5 Participants
|
|
Weight
Female
|
59.1 kg
STANDARD_DEVIATION 13 • n=5 Participants
|
|
Weight
Male
|
66.6 kg
STANDARD_DEVIATION 11.4 • n=5 Participants
|
|
Weight
Total
|
63.5 kg
STANDARD_DEVIATION 12.6 • n=5 Participants
|
PRIMARY outcome
Timeframe: From baseline to Day 57Population: The MITT set was used for primary analyses (89) participants
PANSS, a 30-item scale where each symptom is rated on a severity scale ranging from 1 (absent) - 7 (extreme), total score is 30 - 210. Description of the reporting Groups: Evaluate the efficacy of Quetiapine XR with daily dose 400 mg - 800 mg used as mono-therapy in the treatment of acute schizophrenic patients by evaluation of the change from baseline to Day 57 in total score of PANSS using the last observation carried forward (LOCF) method
Outcome measures
| Measure |
Quetiapine XR
n=89 Participants
This is an 8-week, multi-centre, open-label, non-comparative study to evaluate the efficacy and safety of Quetiapine XR with daily dose 400mg-800mg used as mono-therapy in the treatment of acute schizophrenic patients
|
|---|---|
|
The Change in Positive and Negative Syndrome Scale(PANSS)Total Score
|
-26.8 score on a scale
Standard Deviation 4.2
|
SECONDARY outcome
Timeframe: From baseline to Day 57Population: The MITT set was used for primary analyses (89) participants
To evaluate the change of positive symptoms from baseline to Day 57 in PANSS positive score, a 7-item scale where eash symptom is rated on a severity scale ranging from 1 (absent) - 7 (extreme)
Outcome measures
| Measure |
Quetiapine XR
n=89 Participants
This is an 8-week, multi-centre, open-label, non-comparative study to evaluate the efficacy and safety of Quetiapine XR with daily dose 400mg-800mg used as mono-therapy in the treatment of acute schizophrenic patients
|
|---|---|
|
Positive and Negative Syndrome Scale (PANSS) Positive Score
|
-7.4 score on a scale
Standard Deviation 1.2
|
SECONDARY outcome
Timeframe: From baseline to Day 57Population: The MITT set was used for primary analyses (89) participants
To evaluate the change of negative symptoms from baseline to Day 57 in PANSS negative score, a 7-item scale where each symptom is rated on a severity scale ranging from 1 (absent) - 7 (extreme)
Outcome measures
| Measure |
Quetiapine XR
n=89 Participants
This is an 8-week, multi-centre, open-label, non-comparative study to evaluate the efficacy and safety of Quetiapine XR with daily dose 400mg-800mg used as mono-therapy in the treatment of acute schizophrenic patients
|
|---|---|
|
Positive and Negative Syndrome Scale (PANSS) Negative Score
|
-6.2 score on a scale
Standard Deviation 1.3
|
SECONDARY outcome
Timeframe: From baseline to Day 57Population: The MITT set was used for primary analyses (89) participants
To evaluate the change of general psychopathology symptoms from baseline to Day 57 in PANSS general score, a 16-item scale where each symptom is rated on a severity scale ranging from 1 (absent) to - 7 (extreme)
Outcome measures
| Measure |
Quetiapine XR
n=89 Participants
This is an 8-week, multi-centre, open-label, non-comparative study to evaluate the efficacy and safety of Quetiapine XR with daily dose 400mg-800mg used as mono-therapy in the treatment of acute schizophrenic patients
|
|---|---|
|
Positive and Negative Syndrome Scale (PANSS) General Psychopathology Score
|
-13.2 score on a scale
Standard Deviation 2.3
|
SECONDARY outcome
Timeframe: From baseline to Day 57Population: The MITT set was used for primary analyses (89) participants
The Clinical Global Impression - Severity (CGI-S) and - illness (CGI-I) is used in this study. The CGI-S is scored to rate the patient's current clinical state. The CGI-I is scored to rate the patient's change from baseline CGI. Each CGI item is scored on a scale from 1 to 7 (CGI-S: 1 = Normal, not ill, 7= Among the most extremely ill patients/ CGI-I: 1= very much improved, 7= very much worse). CGI-I scores greater than 4 indicate worsening, while scores less than 4 indicate improvement
Outcome measures
| Measure |
Quetiapine XR
n=89 Participants
This is an 8-week, multi-centre, open-label, non-comparative study to evaluate the efficacy and safety of Quetiapine XR with daily dose 400mg-800mg used as mono-therapy in the treatment of acute schizophrenic patients
|
|---|---|
|
Clinical Global Impression (CGI) Score
|
-1.46 score on a scale
Standard Deviation 0.25
|
SECONDARY outcome
Timeframe: From baseline to Day 57Population: The MITT set was used for primary analyses (89) participants
To treat depressive symptoms in acute schizophrenic patients by evaluation of the change from baseline to day 67 in MADRS total score, a 10-item scale for the evaluation of depressive symptoms. Each MADRS item is rated on a 0-6 scale, higher MADRS scores indicate higher levels of depressive symptoms.
Outcome measures
| Measure |
Quetiapine XR
n=89 Participants
This is an 8-week, multi-centre, open-label, non-comparative study to evaluate the efficacy and safety of Quetiapine XR with daily dose 400mg-800mg used as mono-therapy in the treatment of acute schizophrenic patients
|
|---|---|
|
Montgomery-Asberg Depression Rating Scale (MADRS) Total Score
|
-9.44 score on a scale
Standard Deviation 2
|
SECONDARY outcome
Timeframe: From baseline to Day 57Population: The MITT set was used for primary analyses (89) participants
To improve functional capability in acute schizophrenic patients by evaluation of the change from baseline to Day 57 in GAF scale score, a single-item rating scale for evaluating the overall functioning on a continuum from psychologic or psychiatric sickness to health.
Outcome measures
| Measure |
Quetiapine XR
n=81 Participants
This is an 8-week, multi-centre, open-label, non-comparative study to evaluate the efficacy and safety of Quetiapine XR with daily dose 400mg-800mg used as mono-therapy in the treatment of acute schizophrenic patients
|
|---|---|
|
Global Assessment of Functioning (GAF) Score
|
17.9 score on a scale
Standard Deviation 2.9
|
Adverse Events
Quetiapine XR
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Quetiapine XR
n=94 participants at risk
This is an 8-week, multi-centre, open-label, non-comparative study to evaluate the efficacy and safety of Quetiapine XR with daily dose 400mg-800mg used as mono-therapy in the treatment of acute schizophrenic patients
|
|---|---|
|
Psychiatric disorders
Insomnia
|
23.4%
22/94
Safety population who were taking at least one dose of study treatment were used for the safety analyses (94) participants
|
|
Psychiatric disorders
Anxiety
|
11.7%
11/94
Safety population who were taking at least one dose of study treatment were used for the safety analyses (94) participants
|
|
Psychiatric disorders
Agitation
|
5.3%
5/94
Safety population who were taking at least one dose of study treatment were used for the safety analyses (94) participants
|
|
Gastrointestinal disorders
Constipation
|
25.5%
24/94
Safety population who were taking at least one dose of study treatment were used for the safety analyses (94) participants
|
|
Gastrointestinal disorders
Dyspepsia
|
9.6%
9/94
Safety population who were taking at least one dose of study treatment were used for the safety analyses (94) participants
|
|
General disorders
Toothache
|
5.3%
5/94
Safety population who were taking at least one dose of study treatment were used for the safety analyses (94) participants
|
|
Nervous system disorders
Sedation
|
12.8%
12/94
Safety population who were taking at least one dose of study treatment were used for the safety analyses (94) participants
|
|
Nervous system disorders
Headache
|
8.5%
8/94
Safety population who were taking at least one dose of study treatment were used for the safety analyses (94) participants
|
|
Nervous system disorders
Dizziness
|
5.3%
5/94
Safety population who were taking at least one dose of study treatment were used for the safety analyses (94) participants
|
|
Renal and urinary disorders
Dysuria
|
5.3%
5/94
Safety population who were taking at least one dose of study treatment were used for the safety analyses (94) participants
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60