Trial Outcomes & Findings for Efficacy and Safety of SEROQUEL Extended Release (XR) in Acute Schizophrenia (NCT NCT00954122)
NCT ID: NCT00954122
Last Updated: 2013-01-08
Results Overview
PANSS- Excited Component (EC) subscale score will be calculated by adding together the following item scores: excitement (positive subscale item 4); hostility (positive subscale item 7); tension (general subscale item 4); uncooperativeness (general subscale item 8); poor impulse control (general subscale item 14). This is rated on a 7-point Likert scale from 'absent' to 'extremely severe' (score range 5 to 35 points; mean scores = 20 points clinically corresponds to severe agitation). Lower value gives the better outcome.
COMPLETED
PHASE4
35 participants
Baseline and Day 21
2013-01-08
Participant Flow
18 Years to 65 Years Male \& Female Acte schizophrenia (DSM-IV) Positive and Negative Syndrome Scale (PANSS) score at least 75, Clinical Global Impression (CGI)
40 patients enrolled, 35 patients randomised and 28 patients completed the study
Participant milestones
| Measure |
Quetiapine Fumarate XR
This is a one arm Study. Patients were on quetiapine XR 300 mg on day 1, 600 mg on day 2, and 400-800 mg (at investigator's discretion) on day 3 and onwards
|
|---|---|
|
Overall Study
STARTED
|
35
|
|
Overall Study
COMPLETED
|
28
|
|
Overall Study
NOT COMPLETED
|
7
|
Reasons for withdrawal
| Measure |
Quetiapine Fumarate XR
This is a one arm Study. Patients were on quetiapine XR 300 mg on day 1, 600 mg on day 2, and 400-800 mg (at investigator's discretion) on day 3 and onwards
|
|---|---|
|
Overall Study
Withdrawal by Subject
|
5
|
|
Overall Study
Adverse Event
|
1
|
|
Overall Study
Safety Reason
|
1
|
Baseline Characteristics
Efficacy and Safety of SEROQUEL Extended Release (XR) in Acute Schizophrenia
Baseline characteristics by cohort
| Measure |
Quetiapine Fumarate XR
n=35 Participants
This is a one arm Study. Patients were on quetiapine XR 300 mg on day 1, 600 mg on day 2, and 400-800 mg (at investigator's discretion) on day 3 and onwards
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
35 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
|
Age Continuous
|
38.3 years
STANDARD_DEVIATION 11 • n=5 Participants
|
|
Sex: Female, Male
Female
|
11 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
24 Participants
n=5 Participants
|
|
Region of Enrollment
Malaysia
|
35 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline and Day 21Population: ITT population, which comprise of patients who have baseline and at least ONE (1) set of post-baseline PANSS assessments. No imputation on PANSS-EC score.
PANSS- Excited Component (EC) subscale score will be calculated by adding together the following item scores: excitement (positive subscale item 4); hostility (positive subscale item 7); tension (general subscale item 4); uncooperativeness (general subscale item 8); poor impulse control (general subscale item 14). This is rated on a 7-point Likert scale from 'absent' to 'extremely severe' (score range 5 to 35 points; mean scores = 20 points clinically corresponds to severe agitation). Lower value gives the better outcome.
Outcome measures
| Measure |
Quetiapine Fumarate XR
n=35 Participants
Patients were on quetiapine XR 300 mg on day 1, 600 mg on day 2, and 400-800 mg (at investigator's discretion) on day 3 and onwards
|
|---|---|
|
Change From Baseline in Positive and Negative Syndrome Scale Excited Component (PANSS-EC) Score
|
-7.5 Scores on a scale
Standard Deviation 4
|
SECONDARY outcome
Timeframe: Baseline and Day 21Population: ITT population, which comprise of patients who have baseline and at least ONE (1) set of post-baseline PANSS assessments. No imputation on PANSS Negative score.
Positive scale includes 7 Items (Delusions, Conceptual disorganization, Hallucinations, Hyperactivity, Grandiosity, Suspiciousness/persecution, Hostility)and is calculated by adding the positive subscale item scores. Minimum score is 7, maximum score is 49. General Psychopathology scale:16 items (Somatic concern, Anxiety, Guilt feelings, Tension, Mannerisms and posturing, Depression, Motor retardation, Uncooperativeness, Unusual thought content, Disorientation, Poor attention, Lack of judgment and insight, Disturbance of volition, Poor impulse control, Preoccupation, Active social avoidance). Minimum score is 16, maximum score is 112. The higher score- the worse outcome. The biggest reduction of score from baseline- a better efficacy. Measure includes PANSS-Positive (range 8-30), PANSS-General Psychopathological (PANSS-G)(range 17-70), total PANSS score (range 37-143), PANSS aggression, hostility and depression cluster scores (range 4-19).
Outcome measures
| Measure |
Quetiapine Fumarate XR
n=35 Participants
Patients were on quetiapine XR 300 mg on day 1, 600 mg on day 2, and 400-800 mg (at investigator's discretion) on day 3 and onwards
|
|---|---|
|
Change From Baseline to Final Visit at Day 21 in PANSS Positive, General Psychopathological Scores.
|
-9.3 Scores on a scale
Standard Deviation 5.5
|
SECONDARY outcome
Timeframe: Baseline and Day 21Population: ITT population, which comprise of patients who have baseline and at least ONE (1) set of post-baseline PANSS assessments. No imputation on PANSS Positive score.
Negative scale includes 7 items (Blunted affect, Emotional withdrawal, Poor rapport, Passive/apathetic social withdrawal, Difficulty in abstract thinking, Lack of spontaneity and flow of conversation, Stereotyped thinking)and is calculated by adding the negative subscale item scores. Minimum score is 7, maximum score is 49. General Psychopathology scale includes 16 Items (Somatic concern, Anxiety, Guilt feelings, Tension, Mannerisms and posturing, Depression, Motor retardation, Uncooperativeness, Unusual thought content, Disorientation, Poor attention, Lack of judgment and insight, Disturbance of volition, Poor impulse control, Preoccupation, Active social avoidance). Minimum score is 16, maximum score is 112. The higher score- the worse outcome. Measure includes PANSS-Negative (range 8-37), PANSS-General Psychopathological (PANSS-G)(range 17-70), total PANSS score (range 37-143), PANSS aggression, hostility and depression cluster scores (range 4-19).
Outcome measures
| Measure |
Quetiapine Fumarate XR
n=35 Participants
Patients were on quetiapine XR 300 mg on day 1, 600 mg on day 2, and 400-800 mg (at investigator's discretion) on day 3 and onwards
|
|---|---|
|
Change From Baseline to Final Visit at Day 21 in PANSS Negative, General Psychopathological Scores
|
-5.7 Scores on a scale
Standard Deviation 4.9
|
SECONDARY outcome
Timeframe: Baseline and Day 21Population: ITT population, which comprise of patients who have baseline and at least ONE (1) set of post-baseline PANSS assessments. No imputation on PANSS Total score.
Positive and Negative Syndrome Scale (PANSS) total score is a medical scale used for measuring symptom severity of patients with schizophrenia. It is calculated by adding together PANSS-Positive (minimum score = 7, maximum score = 49, PANSS-Negative (minimum score = 7, maximum score = 49), PANSS-General Psychopathological (PANSS-G) subscale scores (minimum score = 16, maximum score = 112), supplementary subscale item scores. The minimum is 30, maximum is 210. Total PANSS score classification: Mildly ill 58- 74, Moderately ill 75-94, Markly ill 95- 115, Severely ill \>116.
Outcome measures
| Measure |
Quetiapine Fumarate XR
n=35 Participants
Patients were on quetiapine XR 300 mg on day 1, 600 mg on day 2, and 400-800 mg (at investigator's discretion) on day 3 and onwards
|
|---|---|
|
Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score
|
-33.2 Scores on a scale
Standard Deviation 21.3
|
SECONDARY outcome
Timeframe: Baseline and Day 21Population: ITT population, which comprise of patients who have baseline and at least ONE (1) set of post-baseline PANSS (Positive and Negative Syndrome Scale) assessments. No imputation on CGI-S score.
Clinical Global Impression, Severity (CGI-S) is a single-item (7-point) scale that evaluates the overall severity of the subject's mental illness. A reduction in score indicates an improvement in the subject's condition. The CGI-S assessment should be based upon the subject's symptoms during the previous week. Change from baseline in CGI-S score is calculated by subtracting the CGI-S score at baseline from the CGI-S score at the relevant time point.
Outcome measures
| Measure |
Quetiapine Fumarate XR
n=35 Participants
Patients were on quetiapine XR 300 mg on day 1, 600 mg on day 2, and 400-800 mg (at investigator's discretion) on day 3 and onwards
|
|---|---|
|
Change From Baseline in Clinical Global Impression-Severity Scale (CGI-S)
|
-1.2 scores on a scale
Standard Deviation 0.9
|
SECONDARY outcome
Timeframe: Baseline and Day 21Population: ITT population, which comprise of patients who have baseline and at least ONE (1) set of post-baseline PANSS (Positive and Negative Syndrome Scale) assessments. No imputation on CGI-I score.
Clinical Global Impression, Improvement (CGI-I) is a single-item (7-point) scale that evaluates the overall improvement in the subject's mental. A reduction in score indicates an improvement in the subject's condition. This assessment is based on the improvement since initiation of the study treatment. Change in CGI-I score is analyzed by comparing CSI-score at the relevant time point to the baseline CGI-I score.
Outcome measures
| Measure |
Quetiapine Fumarate XR
n=35 Participants
Patients were on quetiapine XR 300 mg on day 1, 600 mg on day 2, and 400-800 mg (at investigator's discretion) on day 3 and onwards
|
|---|---|
|
Change From Baseline in Absolute Clinical Global Impression-Improvement (CGI-I) Scale
Baseline
|
3.9 Scores on a scale
Standard Deviation 0.4
|
|
Change From Baseline in Absolute Clinical Global Impression-Improvement (CGI-I) Scale
Day 21
|
2.4 Scores on a scale
Standard Deviation 1.2
|
SECONDARY outcome
Timeframe: Baseline and Day 21Population: ITT population, which comprise of patients who have baseline and at least ONE (1) set of post-baseline PANSS assessments. No imputation on Outcome Measurement.
Excited Component was used to evaluate the control of agitation and aggression in patients with schizophrenia. Difference in mean score at baseline and day 21 is used to assess the improvement. It is shown by reduction in mean score and confirmed by p value lower than 0,05. Positive and Negative Syndrome Scale Excited Component (PANSS-EC) is a subscale score which is calculated by adding together the following item scores: excitement (positive subscale item 4); hostility (positive subscale item 7); tension (general subscale item 4); uncooperativeness (general subscale item 8); poor impulse control (general subscale item 14). This is rated on a 7-point Likert scale from 'absent' to 'extremely severe' (score range 5 to 35 points; mean scores = 20 points clinically corresponds to severe agitation).
Outcome measures
| Measure |
Quetiapine Fumarate XR
n=35 Participants
Patients were on quetiapine XR 300 mg on day 1, 600 mg on day 2, and 400-800 mg (at investigator's discretion) on day 3 and onwards
|
|---|---|
|
Change of the Positive and Negative Syndrome Scale Excited Component (PANSS-EC) Score Compared From Baseline to Day 21.
|
-33.2 Scores on a scale
Standard Deviation 21.3
|
Adverse Events
Quetiapine Fumarate XR
Serious adverse events
| Measure |
Quetiapine Fumarate XR
n=35 participants at risk
This is a one arm Study. Patients were on quetiapine XR 300 mg on day 1, 600 mg on day 2, and 400-800 mg (at investigator's discretion) on day 3 and onwards
|
|---|---|
|
Psychiatric disorders
Hospitalization
|
2.9%
1/35
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: OTHER